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Laparoscopic Sacrocolpopexy for Management of Pelvic Organ Prolapse Enhances Quality of Life at One Year: A Prospective Observational Study
Original Article
Laparoscopic Sacrocolpopexy for Management of Pelvic Organ Prolapse Enhances Quality of Life at One Year: A Prospective Observational Study Thomas Perez, MD, Patrice Crochet, MD*, Ger^ ome Descargues, MD, Philippe Tribondeau, MD, Franc¸oise Soffray, MD, Pierre Gadonneix, MD, A. Loundou, MD, and K. Baumstarck-Barrau, MD From the Department of Gynecology, Clinique La Casamance, Aubagne, France (Dr. Perez), Department of Gynecology, Centre Hospitalier Henry Duffaut, Avignon, France (Dr. Crochet), Department of Gynecology, Clinique Saint Hilaire, Rouen, France (Dr. Descargues), Department of Gynecology, Clinique Saint Martin, Pessac, France (Drs. Tribondeau and Soffray), Department of Gynecology, Hospital des Diaconesses, Paris, France (Dr. Gadonneix), and Self-perceived Health Assessment Research Unit and Department of Public Health, Marseille, France (Drs. Loundou and Baumstarck-Barrau).
ABSTRACT Study Objective: Assessment of 1-year quality of life outcome of patients treated with laparoscopic sacrocolpopexy. Design: A prospective multicenter observational study (Canadian Task Force classification II-3). Setting: Four French medical centers. Patients: A total of 94 women who underwent laparoscopic sacrocolpopexy for pelvic organ prolapse between June 2006 and May 2007 were included in the study. Measurements and Main Results: Women attended a research clinic where they completed validated quality of life questionnaires and were examined. Women were assessed before and 1 year after surgery for the degree and impact of vaginal, urinary, and bowel symptoms with validated quality of life questionnaires, evaluation of sexual function with a validated questionnaire, and pelvic organ support was assessed by a Pelvic Organ Prolapse Quantification score. Mean age of the women was 58.8 years. Anatomic success occurred in 94% of women. Concomitant urinary continence surgery was performed in 39% of cases. All the scores of quality of life and sexuality were significantly improved at 1 year. Conclusions: Laparoscopic sacrocolpopexy for pelvic floor prolapse is a safe and effective treatment that has a positive impact on every aspect of quality of life (symptoms, social impact, sexual function) in the medium term. Journal of Minimally Invasive Gynecology (2011) 18, 747–754 Ó 2011 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopy; Sacrocolpopexy; Pelvic organ prolapse; Quality of life
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Pelvic organ prolapse is a highly prevalent disorder estimated to affect up to 40% of women [1]. The prevalence of this disease is currently increasing in developed countries, primarily because of increased life expectancies. The lifetime risk of requiring surgical repair is estimated at 11% [2]. The authors have no commercial, proprietary, or financial interest and support in the products or companies described in the article. Corresponding author: Mr. Patrice Crochet, Hopital Henry Duffaut, Department of Gynaecology, 305 rue Raoul Follereau, Avignon cedex 9 84902, France. E-mail: [email protected] Submitted June 3, 2011. Accepted for publication August 3, 2011. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2011 AAGL. All rights reserved. doi:10.1016/j.jmig.2011.08.002
Although not a life-threatening condition, disorders of the pelvic floor cause a broad range of symptoms, such as pelvic organ prolapse and urinary and fecal incontinence. These symptoms have a social, psychological, and sexual impact that can significantly alter the quality of life of affected women [3]. Surgical treatment options include vaginal approach, laparotomy, and, more recently, laparoscopy. Abdominal sacral colpopexy is associated with a lower rate of recurrence and dyspareunia than with vaginal sacrospinous colpopexy [4]. However, laparotomy involves longer recovery times than the vaginal approach.
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Laparoscopic sacrocolpopexy (LSC) provides the potential to combine success rates obtained by laparotomy with the benefits of miniinvasive surgery. The feasibility of this technique has been largely demonstrated, as well as its good anatomic results and low morbidity rate [5–9]. A recent study comparing LSC (efficacy/tolerance) with vaginal sacrospinofixation reported a higher satisfaction rate and objective success rate with LSC [10]. Surgical success on the basis of anatomic outcomes is, however, poorly correlated with the patient’s experience [11,12]. Indeed, some cases of surgical failure are associated with few symptoms [8], and conversely patients with good anatomic outcomes can remain dissatisfied with the surgical cure [12]. It is therefore important to measure quality of life in women with pelvic floor disorders when evaluating the efficacy of this surgical procedure. Quality of life can be assessed through a validated self-administered questionnaire specifically developed for women with pelvic organ prolapse: the Pelvic Floor Distress Inventory (PFDI) focuses on symptom distress, the Pelvic Floor Impact Questionnaire (PFIQ) on life impact [13], and the Pelvic Incontinence Sexual Questionnaire (PSIQ) on sexual function [14]. The primary objective of this prospective multicenter observational study was to estimate the change of patient self-reported outcomes 1 year after LSC for pelvic organ prolapse and to determine the impact of 6 parameters of interest on these changes. The secondary objectives were to report anatomic outcomes, morbidity, and women’s overall satisfaction rates. Materials and Methods Subjects Patients included in the study presented a pelvic organ prolapse stage 2 to 4 according to the Pelvic Organ Prolapse Quantitation (POP-Q) classification system [11]. They all filled in a self-administered questionnaire and signed a consent form. Exclusion criteria were contraindication to laparoscopy, current genital or urinary infection, and previous pelvic radiotherapy. Previous surgical treatment for prolapse was not an exclusion criterion. Surgical Technique Surgery performed was laparoscopic sacrocolpopexy, with the following points: (1) A polyester mesh kit (Pro-Swing PS2; Swing Technologies, Montpellier, France) was used. (2) Posterior mesh was placed along the full length of the posterior vaginal wall and fixed at the lower end on the levator ani muscles and laterally on the uterosacral ligaments. The cranial aspect of this mesh was secured to the sacral promontory or to the posterior peritoneum. (3) Anterior mesh was fixed on the upper third of the anterior vaginal wall and at the uterine isthmus (for patients with the uterus in place). The cranial aspect of this mesh was secured to the sacral promontory (appropriate mesh tension was controlled visually or by simulta-
neous vaginal examination). (4) Sutures or staples were used for fixation. (5) Finally the peritoneum was closed with a polyglactin running suture. (6) Antibiotic (cefazoline 2 g) was administered during the procedure. Additional procedures were undertaken as appropriate: (1) Transobturator tape placement in cases of stress urinary incontinence diagnosed at the preoperative exanimation, (2) laparoscopic subtotal hysterectomy, and (3) annexectomy or tubal sterilization. Total hysterectomy and perineorrhaphy were excluded. All procedures and postoperative follow-up evaluations were performed by 5 gynecologic surgeons practicing in 4 French medical centers (both private and public institutions). Every physician had previous experience of LSC (more than 30 procedures performed), and all were members of the French quality of life promotofixation group (Groupe d’Etude de la Promontofixation et son Impact sur la Qualite de vie). Assessment Tools Patient outcomes were documented with 3 selfadministered quality of life questionnaires developed for female patients presenting all forms of pelvic floor disorders: the Pelvic Floor Distress Inventory (PFDI) focused on symptom distress, the Pelvic Floor Impact Questionnaire (PFIQ) assessed quality of life [13], and a short version of the Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire (PSIQ) assessed sexual function [14]. A French version of PFID and PFIQ was used [15]. A short form of PFDI and PFIQ has been recently validated in French [16,17]. PFDI questionnaire was used to assess symptom distress related to pelvic floor dysfunction. The PFDI has 46 items and contains 3 scales: the Urinary Distress Inventory (UDI), the Pelvic Organ Prolapse Distress Inventory (POPDI), and the Colorectal–anal Distress Inventory (CRADI). The PFIQ was used to assess life and emotional impact of pelvic floor disorders. The PFIQ has a total of 93 items and contains 3 scales: The Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colo-Rectal-Anal Impact Questionnaire (CRAIQ), each with 31 items. Twenty-five of the 31 questions refer to the degree to which symptoms related to bladder, bowel, and vaginal function affect everyday life activities. The remaining 6 questions ask about the emotional effects of pelvic floor symptoms on women, whether they cause embarrassment or frustration. A high score for the PFDI/PFIQ scales represents a high level of symptoms. A short French version of the PSIQ (PSIQ-12) was used to evaluate sexual function in these patients [18]. PSIQ-12 contains 12 items divided into 3 domains labeled behavioral/emotive, physical, and partner related. A global PSIQ-12 score is calculated. Higher PISQ-12 scores indicate better sexual function. Three additional questions were asked of the patients to assess overall satisfaction with respect to the surgical procedure. The 3 questions asked were as follow: (1) Are you
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Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
generally satisfied with the surgical procedure? (Very satisfied/Satisfied/Moderately satisfied/Not satisfied). (2) If needed, would you agree to undergo this procedure one more time? (Yes/No). (3) Would you advise this surgery to a friend? (Yes/No). Anatomic results were assessed during an examination with the POP-Q system [11]. The result was considered successful when less than stage 2 at any point of measure 12 months after surgery. Data Collection Women were seen before the surgery (T0) and 12 months after surgery (T1) during consultations. At T0 and T1, all women were asked to complete PFDI, PFIQ, and PSIQ-12 questionnaires, and a physical examination was performed to determine the type and degree of prolapse with the POP-Q system. The preoperative evaluation included a clinical examination (including a Bonney and Ulmsten maneuver) to determine the presence of concurrent or occult stress urinary incontinence before the LSC. Details of surgical procedures were collected from operative reports, such as posterior meshes fixed to the sacral promontory or to the posterior peritoneum, subtotal hysterectomy, operative adverse events, and tension-free vaginal tape procedure. At T1, clinicians reported postoperative complications that happened during the follow-up period: erosion, mesh contraction, urinary incontinence, pain, and other adverse events. Answers to the 3 additional questions were collected at T1. Six variables were identified as parameters of interest: preoperative hysterectomy (no/yes), posterior mesh fixed to the promontory (no/yes), posterior compartment prolapse (no/yes), prolapse stage POP-Q (stage 2/stage 3 or 4), preoperative SUI (no/yes), age group (,60 years/R60 years). Statistical Analysis Categorical parameters were described with the number and percentage of subjects, and continuous parameters using
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mean and standard deviation. Seven scores of the scale dimensions were computed by use of appropriate algorithms: UDI, CRADI, POPDI, UIQ, CRAIQ, POPIQ, and PISQ-12. The change of scores between T0 and T1 was tested with the Wilcoxon signed-rank test. Ratios were computed from the scores of the 7 dimensions as follows: (score T0 – score T1)/score T0 ! 100. For each ratio, 4 categories of women were arbitrarily defined: (1) women with worsened conditions: ratio ,210%; (2) women with stable conditions: ratio R210% and %10%; (3) women with improved conditions: ratio .10% and %50%; (4) women with very improved conditions: ratio .50%. The 6 parameters of interest were compared between the 2 groups: ‘‘worsened group’’ and ‘‘stable/improved group’’ by use of c2 testing or Fisher’s exact test for categorical variables. The statistical analyses were performed with the SPSS version 15.0 software package (SPSS Inc., Chicago, IL). All tests were 2-sided. The statistical significance threshold was defined as p , .05.
Results Subjects Between June 2006 and May 2007, 94 patients signed the consent form and underwent LSC as described before. A total of 85 patients attended the postoperative clinical examination 12 months after surgery (T1), and 80 responded to the questionnaires at both times T0 and T1. The main characteristics of the 3 groups are detailed in Table 1. Preoperative clinical examination revealed 20 (21%) cases of obvious stress urinary incontinence (95% confidence interval [13%–30%]). Occult stress urinary incontinence was found in 17 women (18%, 95% IC [10–26%]). An anti-incontinence treatment was performed by placement of tension-free vaginal tape in these 37 patients (39.4%, 95% IC [30%–49%]).
Table 1 Characteristics of participants
Age (mean 6 SD) Prolapse stage 2 3–4 Prolapse compartment Anterior Apical Posterior All History of hysterectomy Posterior mesh fixation Subtotal hysterectomy
Consent form and LSC (n 5 94)
Postoperative clinical examination (n 5 85)
Questionnaires at T0 and T1 (n 5 80)
58.79 6 11.35
58.73 6 11.21
58.71 6 10.76
27 (28.7%) 67 (71.3%)
22 (25.9%) 63 (74.1%)
20 (25%) 60 (75%)
82 (87.2%) 73 (77.7%) 63 (67%) 53 (56.4%) 5 (5.3%) 48 (51.1%) 47 (50.0%)
80 (94.1%) 62 (72.9%) 55 (64.7%) 47 (55.3%) 3 (3.5%) 45 (52.9%) 46 (54.1%)
74 (92.5%) 58 (72.5%) 52 (65%) 45 (56.3%) 3 (3.8%) 44 (55%) 42 (52.5%)
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Table 2 Changes in quality of life scales score between T0 and T1 (n 5 94) Mean 6 Standard deviation Scales
T0
PFDI UDIy CRADIy POPDIy PFIQ UIQy CRAIQy POPIQy PISQ 12z
T1
T0–T1
p*
66.57 6 48.64 56.67 6 57.30 81.90 6 55.17
20.14 6 32.15 33.24 6 41.30 25.66 6 40.32
44.32 6 50.02 21.85 6 49.13 55.22 6 66.51
,.001 ,.001 ,.001
144.23 6 49.63 120.15 6 42.54 131.02 6 46.91 33.67 6 7.05
114.18 6 28.20 109.07 6 28.90 105.15 6 18.05 36.08 6 5.42
29.61 6 47.54 11.82 6 37.00 28.91 6 50.26 22.31 6 5.89
,.001 .001 ,.001 .004
* The p value between T0 and T1. y The higher the score, the higher symptom. z The higher the score, the higher the sexual life level.
Quality of Life Scores All scores of the 7 scales (UDI, POPDI, CRADI, UIQ, POPIQ, CRAIQ, PSIQ-12), at T0 and T1, as well as the difference T1–T0, are presented in Table 2. The 3 scales of PFDI and PFIQ revealed significantly lower scores at T1 than at T0, indicating that the women reported fewer symptoms at 1 year than during the preoperative period. PSIQ-12 scores were significantly higher at T1 than at T0, indicating that women reported a better sex life after surgery. The distribution of patients according to scales evolution (worsened/stable/improved/very improved) is displayed in Table 3. Among the 11 patients who showed a worse UDI score after surgery, 10 had worsened stress subscale scores, 4 had worsened obstruction subscale scores, and 8 had worsened irritative/discomfort subscale scores. Among the 14 patients who showed a worse CRADI score after surgery, 11 had worsened incontinence subscale scores, 7 had worsened obstructive subscale scores, 6 had worsened pain/irritation subscale scores, and none had worsened rectal prolapse subscale scores. Links among the 6 Parameters of Interest and the Score Changes None of the 6 parameters of interest (preoperative hysterectomy, posterior mesh fixed to the promontory, posterior compartment prolapse, prolapse stage POP-Q, preoperative
SUI, age group) were significantly linked to score changes (worsened or not worsened) from the 7 studied scales. All results are displayed in Table 4. Among women with worsened UDI scores, none of them presented stress urinary incontinence at the preoperative clinical examination, versus 19 of the 67 women with stable/improved conditions. Women with worsened UDI and UIQ scores tend to have less frequently tension-free vaginal tape placement than women who did not have worsened UDI and UIQ scores (nonsignificant results, p 5 .08 and p 5 .051, respectively). Women with worsened POPIQ and PSIQ-12 scores more frequently tended to have stage 2 than stage 3 or 4 prolapse at T0 (nonsignificant results, p 5 .06 and p 5 .07, respectively). Overall Satisfaction At T1, 98.6% of patients declared they were satisfied or very satisfied with the procedure, 98.6% of patients would undergo the same procedure if needed, and the same percentage would recommend this surgery to a friend. Anatomic Result and Complications Anatomic success (stage 0 or 1) was found in 94.1% of patients at T1. A complication occurred during surgery in
Table 3 Distribution of patients according to scales evolution: worsened/stable/improved/very improved PFDI
Worsened Stable Improved Very improved Total
PFIQ
UDI
CRADI
POPDI
UIQ
CRAIQ
POPIQ
PISQ-12
11 (14.1%) 1 (1.3%) 4 (5.1%) 62 (79.5%) 78
14 (20.6%) 6 (8.8%) 13 (19.1%) 35 (51.5%) 68
7 (9.1%) 3 (3.9%) 10 (13%) 57 (74%) 77
7 (9%) 29 (37.2%) 36 (46.2%) 6 (7.7%) 78
6 (7.8%) 49 (63.6%) 19 (24.7%) 3 (3.9%) 77
2 (2.6%) 39 (51.3%) 26 (34.2%) 9 (11.8%) 76
7 (10.8%) 34 (52.3%) 20 (30.8%) 4 (6.2%) 65
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Table 4
Table 4 Impact of the 6 parameters of interest on self-reported outcomes: ‘‘worsened’’ versus ‘‘stable/improved’’ conditions
Worsened UDI Hysterectomy No 11 (14.7%) Yes 0 (0%) Posterior mesh fixed to the promontory No 4 (11.8%) Yes 7 (15.9%) Posterior compartment prolapse No 1 (3.7%) Yes 10 (19.6%) Prolapse stage (POP-Q) 2 4 (20.0%) 3–4 7 (12.1%) Preoperative SUI No 11(18.6%) Yes 0 (0%) Age ,60 5 (13.9%) R60 6 (14.3%) CRADI Hysterectomy No 14 (21.2%) Yes 0 (0%) Posterior mesh fixed to the promontory No 7 (23.5%) Yes 7 (18.4%) Posterior compartment prolapse No 5 (20.8%) Yes 9 (20.5%) Prolapse stage (POP-Q) 2 4 (22.2%) 3–4 10 (20.0%) Preoperative SUI No 9 (18.1%) Yes 5 (27.8%) Age ,60 7 (21.2%) R60 7 (20.0%) POPDI Hysterectomy No 6 (8.1%) Yes 1 (33.3%) Posterior mesh fixed to the promontory No 5 (15.2%) Yes 2 (4.5%) Posterior compartment prolapse No 2 (7.4%) Yes 5 (10.0%) Prolapse stage (POP-Q) 2 3 (15.0%) 3–4 4 (7.0%)
Stable or improved
Continued Worsened
p Value ..999
64 (85.3) 3 (100%) .747 30 (88.2%) 34 (84.1%) .086 26 (96.3%) 41 (80.4%) .459 16 (80.0%) 51 (87.9%) .057 48 (81.0%) 19 (100%) ..999 31 (86.1%) 36 (85.7%) ..999 52 (78.8%) 2 (100%) .764 23 (76.7%) 31(81.6%) ..999 19 (79.2%) 35 (79.5%) ..999 14 (78.8%) 40 (80.0%) .498 41 (82%) 13 (72.2%) ..999 26 (78.8%) 28 (80.0%) .252 68 (91.9%) 2 (66.7%) .131 28 (84.8%) 45 (95.5%) ..999 25 (92.6%) 45 (90.0%) .367 17 (85.0%) 53 (93.0%) (Continued )
Preoperative SUI No 6 (10.3%) Yes 1 (5.3%) Age ,60 5 (13.9%) R60 2 (4.9%) UIQ Hysterectomy No 7 (9.3%) Yes 0 (0%) Posterior mesh fixed to the promontory No 1 (2.9%) Yes 6 (13.6%) Posterior compartment prolapse No 1 (3.7%) Yes 6 (11.8) Prolapse stage (POP-Q) 2 2 (10.5%) 3–4 5 (8.5%) Preoperative SUI No 7 (11.9%) Yes 0 (0%) Age ,60 3 (8.1%) R60 4 (9.8%) CRAIQ Hysterectomy No 6 (8.1%) Yes 0 (0%) Posterior mesh fixed to the promontory No 3 (8.8%) Yes 3 (7.0%) Posterior compartment prolapse No 4 (14.8%) Yes 2 (4.0%) Prolapse stage (POP-Q) 2 3 (15.8%) 3–4 3 (5.2%) Preoperative SUI No 5 (8.6%) Yes 1 (5.3%) Age ,60 5 (13.5%) R60 1 (2.5%) POPQI Hysterectomy No 2 (2.7%) Yes 0 (0%) Posterior mesh fixed to the promontory No 1 (3%) Yes 1 (2.3%) Posterior compartment prolapse No 1 (3.8%) Yes 1 (2.0%)
Stable or improved
p Value .674
52 (89.7%) 18 (94.7%) .242 31 (86.1%) 39 (95.1%) ..999 68 (90.7%) 3 (100%) .130 33 (97.1%) 38 (86.4%) .411 26 (96.3%) 45 (88.2%) ..999 17 (89.5%) 54 (91.5%) .185 52 (88.1%) 19 (100%) ..999 34 (91.9%) 37 (90.2%) ..999 68 (91.9%) 3 (100%) ..999 31 (91.2%) 40 (93.0%) .176 23 (85.2%) 48 (96.0%) .156 16 (84.2%) 55 (94.8%) ..999 53 (91.4%) 18 (94.7%) .100 32 (86.5%) 35 (97.5%) ..999 71 (97.3%) 3 (100%) ..999 32 (97%) 42 (97.7%) ..999 25 (96.2%) 49 (98.0%) (Continued )
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Table 4 Continued Worsened Prolapse stage (POP-Q) 2 2 (10.5%) 3–4 0 (0%) Preoperative SUI No 2 (3.4%) Yes 0 (0%) Age ,60 2 (5.4%) R60 0 (0%) PISQ-12 Hysterectomy No 6 (9.7%) Yes 1 (33.3%) Posterior mesh fixed to the promontory No 4 (12.5%) Yes 3 (9.1%) Posterior compartment prolapse No 3 (12.5%) Yes 4 (9.8%) Prolapse stage (POP-Q) 2 4 (23.5%) 3–4 3 (6.3%) Preoperative SUI No 6 (12.6%) Yes 1 (6.3%) Age ,60 5 (14.7%) R60 2 (6.5%)
Stable or improved
p Value .06
17 (89.5%) 57 (100%) ..999 56 (96.6%) 18 (100%) .234 35 (94.6%) 39 (100%) .294 56 (90.3%) 2 (66.6%) .708 28 (87.5%) 30 (90.9%) .516 21 (87.5%) 37 (90.2%) .070 13 (76.5%) 45 (93.8%) .671 43 (87.8%) 15 (93.8%) .430 29 (85.3%) 29 (93.5%)
2 cases, without long-term consequences: a bladder injury (diagnosed during the procedure, sutured, and followed by bladder catheterization in the postoperative course) and a sigmoid infracentimetric injury (sutured by minilaparotomy). One patient presented an episode of intestinal obstruction 6 weeks after surgery, which was medically managed successfully. Three women had development of small mesh erosions in the weeks after surgery. These erosions were successfully managed by local treatment. Two patients had painful mesh contractions at T1. Nine patients (9.3%) had minor complications reported in the follow-up period: 1 urinary infection, 1 chronic pelvic pain, 1 rectal discomfort (heaviness feeling) with a good anatomic result and 6 cases of stress urinary incontinence. Among the 6 patients who had stress urinary incontinence after surgery, 4 underwent a tension-free tape placement within the year after the LSC. Discussion There are a large number of surgical techniques described in the literature for pelvic organ prolapse. This can partly be
explained by the variety of clinical presentations but also by the lack of consensus on this issue within the surgical community. LSC is one of the latest options developed to repair prolapse. Disorders of the pelvic floor affect the quality of life of women, and measuring that quality of life is critical when evaluating a therapy. Validated quality of life questionnaires that can assess interrelated symptoms associated with pelvic floor disorders and thus the impact of a therapy have been available since 2001 [13,14]. North et al [19] published an observational study in 2009 on a small number of patients who underwent LSC for vault prolapse. Results showed an improved quality of life 26 months after the procedure according to PFDI and PFIQ scores. Subsequent studies found similar results regarding the impact of LSC on quality of life [20,21]. In a prospective case series of 132 patients undergoing LSC for prolapse with a 12.5-month mean follow-up, Claerhout et al [8] observed good functional outcomes. However, preoperative and postoperative evaluation with another validated quality of life questionnaire (P QOL) [22] was available for only 36 of the 132 women included, and statistical analysis was not conducted on score changes. In a single-center case series of 119 women undergoing LSC for vault prolapse with a 34-month mean follow-up, Sergent et al [20] reported a significant improvement on every aspect of the quality of life measured by validated questionnaires (PFID, PFIQ, and PSIQ-12). This study was intended to further evaluate quality of life outcomes after LSC by use of specific validated quality of life questionnaires, in a multicenter setting. Findings of the study are limited by the 1-year follow-up period that only allows assessment of medium-term outcomes. A longer follow-up period is needed to draw firm conclusions with regard to quality of life and anatomic results. Thus complications inherent to the mesh placement as erosion infection or mesh contraction can happen years after surgery and impair quality of life for these patients [7]. Responses to questionnaires were not available for a small percentage of women operated. It concerns women who were reluctant to address some issues considered as too intimate especially in the PSIQ-12 questionnaire. One point should be discussed regarding our arbitrary definition of the quality of life change. Barber et al [23] have used a different definition of the quality of life change, as the smallest change in score associated with a clinically meaningful change. This minimally important difference was provided only for the UDI and UIQ. Another limitation to consider in looking at the results is that surgeons themselves were the investigators of this study. Thus the physical examination at T0 and T1 was nonblinded. This study provides further evidence that LSC improves quality of life on patients with pelvic floor disorders. Quality of life scores significantly improved on each of the 3 scales used in this study. These main outcomes correlated with the high degree of overall satisfaction (98%) described by the patients.
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Urinary symptoms were improved in most patients (84.6%) according to the UDI. Among the patients with worsened scores (14.1%), most of them presented an impairment of their incontinence subscale. Four patients required treatment for stress incontinence during the follow-up period, and 2 patients reported bothersome symptomatic stress urinary incontinence at T1. These 6 patients with de novo USI represent 6.3% of the study population, and 16.2% of the patients tested negative for USI before surgery. They could have been offered concomitant transobturator tape placement. In this case, prior information on the risks and benefits of this surgery must be provided. Indeed, patients should be informed about the moderate risk for development of postoperative SUI when no concomitant incontinence procedure is performed. The risk of postoperative SUI after a surgery for pelvic floor prolapse has been mentioned by many authors: Misrai et al [24] reported 13% of de novo SUI after laparoscopic promontofixation without concomitant incontinence procedure. Other studies describe a rate of SUI after LSC between 7% and 9.5% [6,8]. The performance of a routine concomitant continence procedure at the time of the sacrocolpopexy remains controversial [26] and appears to be excessive. However, better screening of patients who could benefit from a concomitant continence procedure is required to improve postoperative quality of life. Symptoms directly related to organ prolapse are significantly improved by LSC (POPDI). However, an important percentage of patients have an unchanged impact score (POPIQ). One explanation could be the difficulty for the questionnaire to isolate prolapse-related social impact from other associated factors (emotional or psychological). None of the women required further surgical treatment for prolapse during the follow-up period. However, the followup period is too short to estimate the long-term recurrence rate that can approach 40% according to Higgs et al [1]. The data with regard to functional outcome for the bowel after LSC showed a substantial improvement for most patients. However, the rate of women with worsened scores is important (20.6%) and concerned the following subscales: incontinence, obstruction, and irritation. None of the patient scores were worsened on the posterior compartment prolapse subscale. Pathophysiological study of bowel symptoms that appear or worsen after this procedure remains unclear. Dissection of the upper rectovaginal space and mesh placement may have variable impact depending on patients’ tissues sensitivities. Criteria of sensitivity have yet to be defined and could be the subject of further research. In their studies, Rozet et al [6], Rivoire et al [5], and Xiromeritis et al [25] report postoperative obstructive symptoms at 6%, 14%, and 22.9%, respectively. The negative impact of pelvic floor prolapse on sexual life is well documented [12,27,28]. In this study, a significant improvement in the sexual function questionnaire score (PSIQ-12) was found. An analysis of the tendency showed that the conditions of 37% of women were improved, most were stable, and 10% were worsened. Women’s sexual
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quality of life depends on many parameters, including age, menopause, sexual desire, partner’s health, and body image perception [27,29]. Handa et al [28] reported a moderate improvement in sexual function after sacrocolpopexy by laparotomy. In this study the rate of sexually active women had increased from 66% to 76% 1 year after the procedure. The authors noted that most of these women had a moderate sexual desire before the surgery. Age did not influence outcomes in term of quality of life. If further works confirm this point, LSC should be considered in all women regardless of age (the oldest woman in this study was 84 years old) [30]. There was no influence of the method of posterior mesh placement on the postoperative quality of life (cranial aspect fixed to the sacral promontory or to the posterior peritoneum). This point needs to be confirmed and correlated to the anatomic outcomes in further works. Anatomic outcomes and complication rate are similar to other studies on LSC [8–10]. Three cases of erosions occurred in the postoperative course and were successfully managed by local treatment. Erosion rate in previous studies range from 0% to 5% [8–10,12] and are likely to occur more than 1 year after the procedure. Two patients experienced painful mesh contraction associated with worsened PSIQ-12 scores. Conclusion This prospective study provides further evidence that laparoscopic sacrocolpopexy for pelvic floor prolapse has a positive impact on every aspect of quality of life (symptoms, social impact, and sexual function) and confirms that this procedure is a safe and effective surgical treatment. These results need to be confirmed on a longer term and to be compared with other surgical procedures. Selection of patients who would benefit from a concomitant continence procedure to prevent SUI should be optimized, and women need to be appropriately informed of this issue.
Acknowledgments We thank Pr. Renaud de Tayrac for his help in selecting the questionnaires and Dr. Amit Mishra for his contribution to the article’s English translation. References 1. Higgs PJ, Chua HL, Smith AR. Long term review of laparoscopic sacrocolpopexy. BJOG. 2005;112:1134–1138. 2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501–506. 3. Jelovsek J, Barber M. Advanced pelvic organ prolapse decreases body image and quality of life. Am J Obstet Gynecol. 2006;194:1455–1461. 4. Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010;4:CD004014.
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5. Rivoire C, Botchorishvili R, Canis M, et al. Complete laparoscopic treatment of genital prolapse with meshes including vaginal promontofixation and anterior repair: a series of 138 patients. J Minim Invasive Gynecol. 2007;14:712–718. 6. Rozet F, Mandron E, Arroyo C, et al. Laparoscopic sacral colpopexy approach for genito-urinary prolapse: experience with 363 cases. Eur Urol. 2005;47:230–236. 7. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009;55:1089–1103. 8. Claerhout F, De Ridders D, Roovers JP, et al. Medium term anatomic and functionnal results of laparoscopic sacrocolpopexy beyond the learning curve. Eur Urol. 2009;55:1459–1467. 9. Gadonneix P, Ercoli A, Salet-Lizee D, et al. Laparoscopic sacrocolpopexy with two separate meshes along the anterior and posterior vaginal walls for multicompartment pelvic organ prolapse. J Am Assoc Gynecol Laparosc. 2004;11:29–35. 10. Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O’Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011;204:360. 11. Bump R, Anders Mattiasson, Brubaker L, et al. The standardisation of terminology of female pelvic organ prolapse and pelvic floor disfunction. Am J Obstet Gynecol. 1996;175:10–17. 12. Barber M, Brubaker L, Nygaard I, et al. Pelvic Floor Disorders Network. Defining succes after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114:600–609. 13. Barber M, Kuchibhatla M, Pieper C, Bump R. Psychometric evaluation of 2 comprehensive condition-specifc quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001;185: 1388–1395. 14. Rogers R, Kammerer-Doak D, Villarreal A, Coates K, Qualls Clifford. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol. 2001;184:552–558. 15. De Tayrac R, Chauveau-Lambling A, Fernandez D, Fernandez H. Instruments de mesure de la qualite de vie chez les patientes presentant un prolapsus genito-urinaire. J Gynecol Obstet Biol Reprod. 2003;32:503–523. 16. de Tayrac R, Deval B, Fernandez H, Mares P, Mapi Research Institute. Validation linguistique en franc¸ais des versions courtes des questionnaires de sympt^ omes (PFDI-20) et de qualite de vie (PFIQ-7) chez les patientes presentant un trouble de la statique pelvienne. J Gynecol Obstet Biol Reprod. 2007;36:738–748. 17. Barber MD, Walters MD, Bump RC. Short forms of two conditionspecific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005;193: 103–113.
18. Fatton B, Letouzey V, Lagrange E, Mares P, Jacquetin B, de Tayrac R. [Validation of a French version of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).]. J Gynecol Obstet Biol Reprod (Paris). 2009;38:662–667. 19. North CE, Ali-Ross NS, Smith AR, Reid FM. A prospective study of laparoscopic sacrocolpopexy for the management of pelvic organ prolapse. BJOG. 2009;116:1251–1257. 20. Sergent F, Resch B, Loisel C, Bisson V, Schaal JP, Marpeau L. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Eur J Obstet Gynecol Reprod Biol. 2011;156:217–222. 21. Bui C, Ballester M, Chereau E, Guillo E, Dara€ı E. [Functional results and quality of life of laparoscopic promontofixation in the cure of genital prolapse]. [Article in French]. Gynecol Obstet Fertil. 2010;38: 563–568. 22. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16:176–181. 23. Barber MD, Spino C, Janz NK. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009;200: 580.e1–580.e7. 24. Misra€ı V, Roupr^et M, Cour F, Chartier-Kastler E, Richard F. De novo urinary stress incontinence after laparoscopic sacral colpopexy. BJU Int. 2008;101:594–597. 25. Xiromeritis P, Marotta ML, Royer N, Kalogiannidis I, Degeest P, Devos F. Outcome of laparoscopic sacrocolpopexy with anterior and posterior mesh. Hippokratia. 2009;13:101–110. 26. Brubaker L, Nygaard I, Richter HE, et al. Two-years outcomes after sacrocolpopexy with and without Burch to prevent stress urinary incontinence. Obstet Gynecol. 2008;112:49–55. 27. Fitzgerald MP, Kenton K, Shott S, Brubaker L. Responsiveness of quality of life measurement to change after reconstructive pelvic surgery. Am J Obstet Gynecol. 2002;187:88–92. 28. Handa V, Zyczynski H, Brubaker L, et al. Sexual function before and after sacrocolpopexy for pelvic organ prolapse. Am J Obstet Gynecol. 2007;197:629.e1–629.e5. 29. Barber MD, Visco AG, Wyman JF, Fantl JA, Bump RC. Continence Program for Women Research Group. Sexual function in women with urinary incontinence and pelvic organ prolapse. Obstet Gynecol. 2002;99:281–289. 30. Ghezzi F, Cromi A, Siesto G, et al. Use of laparoscopy in older women undergoing gynecologic procedures: is it time to overcome initial concerns? Menopause. 2010;17:96–103.
Laparoscopic Sacrocolpopexy for Management of Pelvic Organ Prolapse Enhances Quality of Life at One Year: A Prospective Observational Study Thomas Perez, MD, Patrice Crochet, MD*, Ger^ ome Descargues, MD, Philippe Tribondeau, MD, Franc¸oise Soffray, MD, Pierre Gadonneix, MD, A. Loundou, MD, and K. Baumstarck-Barrau, MD From the Department of Gynecology, Clinique La Casamance, Aubagne, France (Dr. Perez), Department of Gynecology, Centre Hospitalier Henry Duffaut, Avignon, France (Dr. Crochet), Department of Gynecology, Clinique Saint Hilaire, Rouen, France (Dr. Descargues), Department of Gynecology, Clinique Saint Martin, Pessac, France (Drs. Tribondeau and Soffray), Department of Gynecology, Hospital des Diaconesses, Paris, France (Dr. Gadonneix), and Self-perceived Health Assessment Research Unit and Department of Public Health, Marseille, France (Drs. Loundou and Baumstarck-Barrau).
ABSTRACT Study Objective: Assessment of 1-year quality of life outcome of patients treated with laparoscopic sacrocolpopexy. Design: A prospective multicenter observational study (Canadian Task Force classification II-3). Setting: Four French medical centers. Patients: A total of 94 women who underwent laparoscopic sacrocolpopexy for pelvic organ prolapse between June 2006 and May 2007 were included in the study. Measurements and Main Results: Women attended a research clinic where they completed validated quality of life questionnaires and were examined. Women were assessed before and 1 year after surgery for the degree and impact of vaginal, urinary, and bowel symptoms with validated quality of life questionnaires, evaluation of sexual function with a validated questionnaire, and pelvic organ support was assessed by a Pelvic Organ Prolapse Quantification score. Mean age of the women was 58.8 years. Anatomic success occurred in 94% of women. Concomitant urinary continence surgery was performed in 39% of cases. All the scores of quality of life and sexuality were significantly improved at 1 year. Conclusions: Laparoscopic sacrocolpopexy for pelvic floor prolapse is a safe and effective treatment that has a positive impact on every aspect of quality of life (symptoms, social impact, sexual function) in the medium term. Journal of Minimally Invasive Gynecology (2011) 18, 747–754 Ó 2011 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopy; Sacrocolpopexy; Pelvic organ prolapse; Quality of life
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Pelvic organ prolapse is a highly prevalent disorder estimated to affect up to 40% of women [1]. The prevalence of this disease is currently increasing in developed countries, primarily because of increased life expectancies. The lifetime risk of requiring surgical repair is estimated at 11% [2]. The authors have no commercial, proprietary, or financial interest and support in the products or companies described in the article. Corresponding author: Mr. Patrice Crochet, Hopital Henry Duffaut, Department of Gynaecology, 305 rue Raoul Follereau, Avignon cedex 9 84902, France. E-mail: [email protected] Submitted June 3, 2011. Accepted for publication August 3, 2011. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2011 AAGL. All rights reserved. doi:10.1016/j.jmig.2011.08.002
Although not a life-threatening condition, disorders of the pelvic floor cause a broad range of symptoms, such as pelvic organ prolapse and urinary and fecal incontinence. These symptoms have a social, psychological, and sexual impact that can significantly alter the quality of life of affected women [3]. Surgical treatment options include vaginal approach, laparotomy, and, more recently, laparoscopy. Abdominal sacral colpopexy is associated with a lower rate of recurrence and dyspareunia than with vaginal sacrospinous colpopexy [4]. However, laparotomy involves longer recovery times than the vaginal approach.
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Laparoscopic sacrocolpopexy (LSC) provides the potential to combine success rates obtained by laparotomy with the benefits of miniinvasive surgery. The feasibility of this technique has been largely demonstrated, as well as its good anatomic results and low morbidity rate [5–9]. A recent study comparing LSC (efficacy/tolerance) with vaginal sacrospinofixation reported a higher satisfaction rate and objective success rate with LSC [10]. Surgical success on the basis of anatomic outcomes is, however, poorly correlated with the patient’s experience [11,12]. Indeed, some cases of surgical failure are associated with few symptoms [8], and conversely patients with good anatomic outcomes can remain dissatisfied with the surgical cure [12]. It is therefore important to measure quality of life in women with pelvic floor disorders when evaluating the efficacy of this surgical procedure. Quality of life can be assessed through a validated self-administered questionnaire specifically developed for women with pelvic organ prolapse: the Pelvic Floor Distress Inventory (PFDI) focuses on symptom distress, the Pelvic Floor Impact Questionnaire (PFIQ) on life impact [13], and the Pelvic Incontinence Sexual Questionnaire (PSIQ) on sexual function [14]. The primary objective of this prospective multicenter observational study was to estimate the change of patient self-reported outcomes 1 year after LSC for pelvic organ prolapse and to determine the impact of 6 parameters of interest on these changes. The secondary objectives were to report anatomic outcomes, morbidity, and women’s overall satisfaction rates. Materials and Methods Subjects Patients included in the study presented a pelvic organ prolapse stage 2 to 4 according to the Pelvic Organ Prolapse Quantitation (POP-Q) classification system [11]. They all filled in a self-administered questionnaire and signed a consent form. Exclusion criteria were contraindication to laparoscopy, current genital or urinary infection, and previous pelvic radiotherapy. Previous surgical treatment for prolapse was not an exclusion criterion. Surgical Technique Surgery performed was laparoscopic sacrocolpopexy, with the following points: (1) A polyester mesh kit (Pro-Swing PS2; Swing Technologies, Montpellier, France) was used. (2) Posterior mesh was placed along the full length of the posterior vaginal wall and fixed at the lower end on the levator ani muscles and laterally on the uterosacral ligaments. The cranial aspect of this mesh was secured to the sacral promontory or to the posterior peritoneum. (3) Anterior mesh was fixed on the upper third of the anterior vaginal wall and at the uterine isthmus (for patients with the uterus in place). The cranial aspect of this mesh was secured to the sacral promontory (appropriate mesh tension was controlled visually or by simulta-
neous vaginal examination). (4) Sutures or staples were used for fixation. (5) Finally the peritoneum was closed with a polyglactin running suture. (6) Antibiotic (cefazoline 2 g) was administered during the procedure. Additional procedures were undertaken as appropriate: (1) Transobturator tape placement in cases of stress urinary incontinence diagnosed at the preoperative exanimation, (2) laparoscopic subtotal hysterectomy, and (3) annexectomy or tubal sterilization. Total hysterectomy and perineorrhaphy were excluded. All procedures and postoperative follow-up evaluations were performed by 5 gynecologic surgeons practicing in 4 French medical centers (both private and public institutions). Every physician had previous experience of LSC (more than 30 procedures performed), and all were members of the French quality of life promotofixation group (Groupe d’Etude de la Promontofixation et son Impact sur la Qualite de vie). Assessment Tools Patient outcomes were documented with 3 selfadministered quality of life questionnaires developed for female patients presenting all forms of pelvic floor disorders: the Pelvic Floor Distress Inventory (PFDI) focused on symptom distress, the Pelvic Floor Impact Questionnaire (PFIQ) assessed quality of life [13], and a short version of the Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire (PSIQ) assessed sexual function [14]. A French version of PFID and PFIQ was used [15]. A short form of PFDI and PFIQ has been recently validated in French [16,17]. PFDI questionnaire was used to assess symptom distress related to pelvic floor dysfunction. The PFDI has 46 items and contains 3 scales: the Urinary Distress Inventory (UDI), the Pelvic Organ Prolapse Distress Inventory (POPDI), and the Colorectal–anal Distress Inventory (CRADI). The PFIQ was used to assess life and emotional impact of pelvic floor disorders. The PFIQ has a total of 93 items and contains 3 scales: The Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colo-Rectal-Anal Impact Questionnaire (CRAIQ), each with 31 items. Twenty-five of the 31 questions refer to the degree to which symptoms related to bladder, bowel, and vaginal function affect everyday life activities. The remaining 6 questions ask about the emotional effects of pelvic floor symptoms on women, whether they cause embarrassment or frustration. A high score for the PFDI/PFIQ scales represents a high level of symptoms. A short French version of the PSIQ (PSIQ-12) was used to evaluate sexual function in these patients [18]. PSIQ-12 contains 12 items divided into 3 domains labeled behavioral/emotive, physical, and partner related. A global PSIQ-12 score is calculated. Higher PISQ-12 scores indicate better sexual function. Three additional questions were asked of the patients to assess overall satisfaction with respect to the surgical procedure. The 3 questions asked were as follow: (1) Are you
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Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
generally satisfied with the surgical procedure? (Very satisfied/Satisfied/Moderately satisfied/Not satisfied). (2) If needed, would you agree to undergo this procedure one more time? (Yes/No). (3) Would you advise this surgery to a friend? (Yes/No). Anatomic results were assessed during an examination with the POP-Q system [11]. The result was considered successful when less than stage 2 at any point of measure 12 months after surgery. Data Collection Women were seen before the surgery (T0) and 12 months after surgery (T1) during consultations. At T0 and T1, all women were asked to complete PFDI, PFIQ, and PSIQ-12 questionnaires, and a physical examination was performed to determine the type and degree of prolapse with the POP-Q system. The preoperative evaluation included a clinical examination (including a Bonney and Ulmsten maneuver) to determine the presence of concurrent or occult stress urinary incontinence before the LSC. Details of surgical procedures were collected from operative reports, such as posterior meshes fixed to the sacral promontory or to the posterior peritoneum, subtotal hysterectomy, operative adverse events, and tension-free vaginal tape procedure. At T1, clinicians reported postoperative complications that happened during the follow-up period: erosion, mesh contraction, urinary incontinence, pain, and other adverse events. Answers to the 3 additional questions were collected at T1. Six variables were identified as parameters of interest: preoperative hysterectomy (no/yes), posterior mesh fixed to the promontory (no/yes), posterior compartment prolapse (no/yes), prolapse stage POP-Q (stage 2/stage 3 or 4), preoperative SUI (no/yes), age group (,60 years/R60 years). Statistical Analysis Categorical parameters were described with the number and percentage of subjects, and continuous parameters using
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mean and standard deviation. Seven scores of the scale dimensions were computed by use of appropriate algorithms: UDI, CRADI, POPDI, UIQ, CRAIQ, POPIQ, and PISQ-12. The change of scores between T0 and T1 was tested with the Wilcoxon signed-rank test. Ratios were computed from the scores of the 7 dimensions as follows: (score T0 – score T1)/score T0 ! 100. For each ratio, 4 categories of women were arbitrarily defined: (1) women with worsened conditions: ratio ,210%; (2) women with stable conditions: ratio R210% and %10%; (3) women with improved conditions: ratio .10% and %50%; (4) women with very improved conditions: ratio .50%. The 6 parameters of interest were compared between the 2 groups: ‘‘worsened group’’ and ‘‘stable/improved group’’ by use of c2 testing or Fisher’s exact test for categorical variables. The statistical analyses were performed with the SPSS version 15.0 software package (SPSS Inc., Chicago, IL). All tests were 2-sided. The statistical significance threshold was defined as p , .05.
Results Subjects Between June 2006 and May 2007, 94 patients signed the consent form and underwent LSC as described before. A total of 85 patients attended the postoperative clinical examination 12 months after surgery (T1), and 80 responded to the questionnaires at both times T0 and T1. The main characteristics of the 3 groups are detailed in Table 1. Preoperative clinical examination revealed 20 (21%) cases of obvious stress urinary incontinence (95% confidence interval [13%–30%]). Occult stress urinary incontinence was found in 17 women (18%, 95% IC [10–26%]). An anti-incontinence treatment was performed by placement of tension-free vaginal tape in these 37 patients (39.4%, 95% IC [30%–49%]).
Table 1 Characteristics of participants
Age (mean 6 SD) Prolapse stage 2 3–4 Prolapse compartment Anterior Apical Posterior All History of hysterectomy Posterior mesh fixation Subtotal hysterectomy
Consent form and LSC (n 5 94)
Postoperative clinical examination (n 5 85)
Questionnaires at T0 and T1 (n 5 80)
58.79 6 11.35
58.73 6 11.21
58.71 6 10.76
27 (28.7%) 67 (71.3%)
22 (25.9%) 63 (74.1%)
20 (25%) 60 (75%)
82 (87.2%) 73 (77.7%) 63 (67%) 53 (56.4%) 5 (5.3%) 48 (51.1%) 47 (50.0%)
80 (94.1%) 62 (72.9%) 55 (64.7%) 47 (55.3%) 3 (3.5%) 45 (52.9%) 46 (54.1%)
74 (92.5%) 58 (72.5%) 52 (65%) 45 (56.3%) 3 (3.8%) 44 (55%) 42 (52.5%)
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Table 2 Changes in quality of life scales score between T0 and T1 (n 5 94) Mean 6 Standard deviation Scales
T0
PFDI UDIy CRADIy POPDIy PFIQ UIQy CRAIQy POPIQy PISQ 12z
T1
T0–T1
p*
66.57 6 48.64 56.67 6 57.30 81.90 6 55.17
20.14 6 32.15 33.24 6 41.30 25.66 6 40.32
44.32 6 50.02 21.85 6 49.13 55.22 6 66.51
,.001 ,.001 ,.001
144.23 6 49.63 120.15 6 42.54 131.02 6 46.91 33.67 6 7.05
114.18 6 28.20 109.07 6 28.90 105.15 6 18.05 36.08 6 5.42
29.61 6 47.54 11.82 6 37.00 28.91 6 50.26 22.31 6 5.89
,.001 .001 ,.001 .004
* The p value between T0 and T1. y The higher the score, the higher symptom. z The higher the score, the higher the sexual life level.
Quality of Life Scores All scores of the 7 scales (UDI, POPDI, CRADI, UIQ, POPIQ, CRAIQ, PSIQ-12), at T0 and T1, as well as the difference T1–T0, are presented in Table 2. The 3 scales of PFDI and PFIQ revealed significantly lower scores at T1 than at T0, indicating that the women reported fewer symptoms at 1 year than during the preoperative period. PSIQ-12 scores were significantly higher at T1 than at T0, indicating that women reported a better sex life after surgery. The distribution of patients according to scales evolution (worsened/stable/improved/very improved) is displayed in Table 3. Among the 11 patients who showed a worse UDI score after surgery, 10 had worsened stress subscale scores, 4 had worsened obstruction subscale scores, and 8 had worsened irritative/discomfort subscale scores. Among the 14 patients who showed a worse CRADI score after surgery, 11 had worsened incontinence subscale scores, 7 had worsened obstructive subscale scores, 6 had worsened pain/irritation subscale scores, and none had worsened rectal prolapse subscale scores. Links among the 6 Parameters of Interest and the Score Changes None of the 6 parameters of interest (preoperative hysterectomy, posterior mesh fixed to the promontory, posterior compartment prolapse, prolapse stage POP-Q, preoperative
SUI, age group) were significantly linked to score changes (worsened or not worsened) from the 7 studied scales. All results are displayed in Table 4. Among women with worsened UDI scores, none of them presented stress urinary incontinence at the preoperative clinical examination, versus 19 of the 67 women with stable/improved conditions. Women with worsened UDI and UIQ scores tend to have less frequently tension-free vaginal tape placement than women who did not have worsened UDI and UIQ scores (nonsignificant results, p 5 .08 and p 5 .051, respectively). Women with worsened POPIQ and PSIQ-12 scores more frequently tended to have stage 2 than stage 3 or 4 prolapse at T0 (nonsignificant results, p 5 .06 and p 5 .07, respectively). Overall Satisfaction At T1, 98.6% of patients declared they were satisfied or very satisfied with the procedure, 98.6% of patients would undergo the same procedure if needed, and the same percentage would recommend this surgery to a friend. Anatomic Result and Complications Anatomic success (stage 0 or 1) was found in 94.1% of patients at T1. A complication occurred during surgery in
Table 3 Distribution of patients according to scales evolution: worsened/stable/improved/very improved PFDI
Worsened Stable Improved Very improved Total
PFIQ
UDI
CRADI
POPDI
UIQ
CRAIQ
POPIQ
PISQ-12
11 (14.1%) 1 (1.3%) 4 (5.1%) 62 (79.5%) 78
14 (20.6%) 6 (8.8%) 13 (19.1%) 35 (51.5%) 68
7 (9.1%) 3 (3.9%) 10 (13%) 57 (74%) 77
7 (9%) 29 (37.2%) 36 (46.2%) 6 (7.7%) 78
6 (7.8%) 49 (63.6%) 19 (24.7%) 3 (3.9%) 77
2 (2.6%) 39 (51.3%) 26 (34.2%) 9 (11.8%) 76
7 (10.8%) 34 (52.3%) 20 (30.8%) 4 (6.2%) 65
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Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
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Table 4
Table 4 Impact of the 6 parameters of interest on self-reported outcomes: ‘‘worsened’’ versus ‘‘stable/improved’’ conditions
Worsened UDI Hysterectomy No 11 (14.7%) Yes 0 (0%) Posterior mesh fixed to the promontory No 4 (11.8%) Yes 7 (15.9%) Posterior compartment prolapse No 1 (3.7%) Yes 10 (19.6%) Prolapse stage (POP-Q) 2 4 (20.0%) 3–4 7 (12.1%) Preoperative SUI No 11(18.6%) Yes 0 (0%) Age ,60 5 (13.9%) R60 6 (14.3%) CRADI Hysterectomy No 14 (21.2%) Yes 0 (0%) Posterior mesh fixed to the promontory No 7 (23.5%) Yes 7 (18.4%) Posterior compartment prolapse No 5 (20.8%) Yes 9 (20.5%) Prolapse stage (POP-Q) 2 4 (22.2%) 3–4 10 (20.0%) Preoperative SUI No 9 (18.1%) Yes 5 (27.8%) Age ,60 7 (21.2%) R60 7 (20.0%) POPDI Hysterectomy No 6 (8.1%) Yes 1 (33.3%) Posterior mesh fixed to the promontory No 5 (15.2%) Yes 2 (4.5%) Posterior compartment prolapse No 2 (7.4%) Yes 5 (10.0%) Prolapse stage (POP-Q) 2 3 (15.0%) 3–4 4 (7.0%)
Stable or improved
Continued Worsened
p Value ..999
64 (85.3) 3 (100%) .747 30 (88.2%) 34 (84.1%) .086 26 (96.3%) 41 (80.4%) .459 16 (80.0%) 51 (87.9%) .057 48 (81.0%) 19 (100%) ..999 31 (86.1%) 36 (85.7%) ..999 52 (78.8%) 2 (100%) .764 23 (76.7%) 31(81.6%) ..999 19 (79.2%) 35 (79.5%) ..999 14 (78.8%) 40 (80.0%) .498 41 (82%) 13 (72.2%) ..999 26 (78.8%) 28 (80.0%) .252 68 (91.9%) 2 (66.7%) .131 28 (84.8%) 45 (95.5%) ..999 25 (92.6%) 45 (90.0%) .367 17 (85.0%) 53 (93.0%) (Continued )
Preoperative SUI No 6 (10.3%) Yes 1 (5.3%) Age ,60 5 (13.9%) R60 2 (4.9%) UIQ Hysterectomy No 7 (9.3%) Yes 0 (0%) Posterior mesh fixed to the promontory No 1 (2.9%) Yes 6 (13.6%) Posterior compartment prolapse No 1 (3.7%) Yes 6 (11.8) Prolapse stage (POP-Q) 2 2 (10.5%) 3–4 5 (8.5%) Preoperative SUI No 7 (11.9%) Yes 0 (0%) Age ,60 3 (8.1%) R60 4 (9.8%) CRAIQ Hysterectomy No 6 (8.1%) Yes 0 (0%) Posterior mesh fixed to the promontory No 3 (8.8%) Yes 3 (7.0%) Posterior compartment prolapse No 4 (14.8%) Yes 2 (4.0%) Prolapse stage (POP-Q) 2 3 (15.8%) 3–4 3 (5.2%) Preoperative SUI No 5 (8.6%) Yes 1 (5.3%) Age ,60 5 (13.5%) R60 1 (2.5%) POPQI Hysterectomy No 2 (2.7%) Yes 0 (0%) Posterior mesh fixed to the promontory No 1 (3%) Yes 1 (2.3%) Posterior compartment prolapse No 1 (3.8%) Yes 1 (2.0%)
Stable or improved
p Value .674
52 (89.7%) 18 (94.7%) .242 31 (86.1%) 39 (95.1%) ..999 68 (90.7%) 3 (100%) .130 33 (97.1%) 38 (86.4%) .411 26 (96.3%) 45 (88.2%) ..999 17 (89.5%) 54 (91.5%) .185 52 (88.1%) 19 (100%) ..999 34 (91.9%) 37 (90.2%) ..999 68 (91.9%) 3 (100%) ..999 31 (91.2%) 40 (93.0%) .176 23 (85.2%) 48 (96.0%) .156 16 (84.2%) 55 (94.8%) ..999 53 (91.4%) 18 (94.7%) .100 32 (86.5%) 35 (97.5%) ..999 71 (97.3%) 3 (100%) ..999 32 (97%) 42 (97.7%) ..999 25 (96.2%) 49 (98.0%) (Continued )
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Table 4 Continued Worsened Prolapse stage (POP-Q) 2 2 (10.5%) 3–4 0 (0%) Preoperative SUI No 2 (3.4%) Yes 0 (0%) Age ,60 2 (5.4%) R60 0 (0%) PISQ-12 Hysterectomy No 6 (9.7%) Yes 1 (33.3%) Posterior mesh fixed to the promontory No 4 (12.5%) Yes 3 (9.1%) Posterior compartment prolapse No 3 (12.5%) Yes 4 (9.8%) Prolapse stage (POP-Q) 2 4 (23.5%) 3–4 3 (6.3%) Preoperative SUI No 6 (12.6%) Yes 1 (6.3%) Age ,60 5 (14.7%) R60 2 (6.5%)
Stable or improved
p Value .06
17 (89.5%) 57 (100%) ..999 56 (96.6%) 18 (100%) .234 35 (94.6%) 39 (100%) .294 56 (90.3%) 2 (66.6%) .708 28 (87.5%) 30 (90.9%) .516 21 (87.5%) 37 (90.2%) .070 13 (76.5%) 45 (93.8%) .671 43 (87.8%) 15 (93.8%) .430 29 (85.3%) 29 (93.5%)
2 cases, without long-term consequences: a bladder injury (diagnosed during the procedure, sutured, and followed by bladder catheterization in the postoperative course) and a sigmoid infracentimetric injury (sutured by minilaparotomy). One patient presented an episode of intestinal obstruction 6 weeks after surgery, which was medically managed successfully. Three women had development of small mesh erosions in the weeks after surgery. These erosions were successfully managed by local treatment. Two patients had painful mesh contractions at T1. Nine patients (9.3%) had minor complications reported in the follow-up period: 1 urinary infection, 1 chronic pelvic pain, 1 rectal discomfort (heaviness feeling) with a good anatomic result and 6 cases of stress urinary incontinence. Among the 6 patients who had stress urinary incontinence after surgery, 4 underwent a tension-free tape placement within the year after the LSC. Discussion There are a large number of surgical techniques described in the literature for pelvic organ prolapse. This can partly be
explained by the variety of clinical presentations but also by the lack of consensus on this issue within the surgical community. LSC is one of the latest options developed to repair prolapse. Disorders of the pelvic floor affect the quality of life of women, and measuring that quality of life is critical when evaluating a therapy. Validated quality of life questionnaires that can assess interrelated symptoms associated with pelvic floor disorders and thus the impact of a therapy have been available since 2001 [13,14]. North et al [19] published an observational study in 2009 on a small number of patients who underwent LSC for vault prolapse. Results showed an improved quality of life 26 months after the procedure according to PFDI and PFIQ scores. Subsequent studies found similar results regarding the impact of LSC on quality of life [20,21]. In a prospective case series of 132 patients undergoing LSC for prolapse with a 12.5-month mean follow-up, Claerhout et al [8] observed good functional outcomes. However, preoperative and postoperative evaluation with another validated quality of life questionnaire (P QOL) [22] was available for only 36 of the 132 women included, and statistical analysis was not conducted on score changes. In a single-center case series of 119 women undergoing LSC for vault prolapse with a 34-month mean follow-up, Sergent et al [20] reported a significant improvement on every aspect of the quality of life measured by validated questionnaires (PFID, PFIQ, and PSIQ-12). This study was intended to further evaluate quality of life outcomes after LSC by use of specific validated quality of life questionnaires, in a multicenter setting. Findings of the study are limited by the 1-year follow-up period that only allows assessment of medium-term outcomes. A longer follow-up period is needed to draw firm conclusions with regard to quality of life and anatomic results. Thus complications inherent to the mesh placement as erosion infection or mesh contraction can happen years after surgery and impair quality of life for these patients [7]. Responses to questionnaires were not available for a small percentage of women operated. It concerns women who were reluctant to address some issues considered as too intimate especially in the PSIQ-12 questionnaire. One point should be discussed regarding our arbitrary definition of the quality of life change. Barber et al [23] have used a different definition of the quality of life change, as the smallest change in score associated with a clinically meaningful change. This minimally important difference was provided only for the UDI and UIQ. Another limitation to consider in looking at the results is that surgeons themselves were the investigators of this study. Thus the physical examination at T0 and T1 was nonblinded. This study provides further evidence that LSC improves quality of life on patients with pelvic floor disorders. Quality of life scores significantly improved on each of the 3 scales used in this study. These main outcomes correlated with the high degree of overall satisfaction (98%) described by the patients.
Perez et al.
Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Urinary symptoms were improved in most patients (84.6%) according to the UDI. Among the patients with worsened scores (14.1%), most of them presented an impairment of their incontinence subscale. Four patients required treatment for stress incontinence during the follow-up period, and 2 patients reported bothersome symptomatic stress urinary incontinence at T1. These 6 patients with de novo USI represent 6.3% of the study population, and 16.2% of the patients tested negative for USI before surgery. They could have been offered concomitant transobturator tape placement. In this case, prior information on the risks and benefits of this surgery must be provided. Indeed, patients should be informed about the moderate risk for development of postoperative SUI when no concomitant incontinence procedure is performed. The risk of postoperative SUI after a surgery for pelvic floor prolapse has been mentioned by many authors: Misrai et al [24] reported 13% of de novo SUI after laparoscopic promontofixation without concomitant incontinence procedure. Other studies describe a rate of SUI after LSC between 7% and 9.5% [6,8]. The performance of a routine concomitant continence procedure at the time of the sacrocolpopexy remains controversial [26] and appears to be excessive. However, better screening of patients who could benefit from a concomitant continence procedure is required to improve postoperative quality of life. Symptoms directly related to organ prolapse are significantly improved by LSC (POPDI). However, an important percentage of patients have an unchanged impact score (POPIQ). One explanation could be the difficulty for the questionnaire to isolate prolapse-related social impact from other associated factors (emotional or psychological). None of the women required further surgical treatment for prolapse during the follow-up period. However, the followup period is too short to estimate the long-term recurrence rate that can approach 40% according to Higgs et al [1]. The data with regard to functional outcome for the bowel after LSC showed a substantial improvement for most patients. However, the rate of women with worsened scores is important (20.6%) and concerned the following subscales: incontinence, obstruction, and irritation. None of the patient scores were worsened on the posterior compartment prolapse subscale. Pathophysiological study of bowel symptoms that appear or worsen after this procedure remains unclear. Dissection of the upper rectovaginal space and mesh placement may have variable impact depending on patients’ tissues sensitivities. Criteria of sensitivity have yet to be defined and could be the subject of further research. In their studies, Rozet et al [6], Rivoire et al [5], and Xiromeritis et al [25] report postoperative obstructive symptoms at 6%, 14%, and 22.9%, respectively. The negative impact of pelvic floor prolapse on sexual life is well documented [12,27,28]. In this study, a significant improvement in the sexual function questionnaire score (PSIQ-12) was found. An analysis of the tendency showed that the conditions of 37% of women were improved, most were stable, and 10% were worsened. Women’s sexual
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quality of life depends on many parameters, including age, menopause, sexual desire, partner’s health, and body image perception [27,29]. Handa et al [28] reported a moderate improvement in sexual function after sacrocolpopexy by laparotomy. In this study the rate of sexually active women had increased from 66% to 76% 1 year after the procedure. The authors noted that most of these women had a moderate sexual desire before the surgery. Age did not influence outcomes in term of quality of life. If further works confirm this point, LSC should be considered in all women regardless of age (the oldest woman in this study was 84 years old) [30]. There was no influence of the method of posterior mesh placement on the postoperative quality of life (cranial aspect fixed to the sacral promontory or to the posterior peritoneum). This point needs to be confirmed and correlated to the anatomic outcomes in further works. Anatomic outcomes and complication rate are similar to other studies on LSC [8–10]. Three cases of erosions occurred in the postoperative course and were successfully managed by local treatment. Erosion rate in previous studies range from 0% to 5% [8–10,12] and are likely to occur more than 1 year after the procedure. Two patients experienced painful mesh contraction associated with worsened PSIQ-12 scores. Conclusion This prospective study provides further evidence that laparoscopic sacrocolpopexy for pelvic floor prolapse has a positive impact on every aspect of quality of life (symptoms, social impact, and sexual function) and confirms that this procedure is a safe and effective surgical treatment. These results need to be confirmed on a longer term and to be compared with other surgical procedures. Selection of patients who would benefit from a concomitant continence procedure to prevent SUI should be optimized, and women need to be appropriately informed of this issue.
Acknowledgments We thank Pr. Renaud de Tayrac for his help in selecting the questionnaires and Dr. Amit Mishra for his contribution to the article’s English translation. References 1. Higgs PJ, Chua HL, Smith AR. Long term review of laparoscopic sacrocolpopexy. BJOG. 2005;112:1134–1138. 2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501–506. 3. Jelovsek J, Barber M. Advanced pelvic organ prolapse decreases body image and quality of life. Am J Obstet Gynecol. 2006;194:1455–1461. 4. Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010;4:CD004014.
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5. Rivoire C, Botchorishvili R, Canis M, et al. Complete laparoscopic treatment of genital prolapse with meshes including vaginal promontofixation and anterior repair: a series of 138 patients. J Minim Invasive Gynecol. 2007;14:712–718. 6. Rozet F, Mandron E, Arroyo C, et al. Laparoscopic sacral colpopexy approach for genito-urinary prolapse: experience with 363 cases. Eur Urol. 2005;47:230–236. 7. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009;55:1089–1103. 8. Claerhout F, De Ridders D, Roovers JP, et al. Medium term anatomic and functionnal results of laparoscopic sacrocolpopexy beyond the learning curve. Eur Urol. 2009;55:1459–1467. 9. Gadonneix P, Ercoli A, Salet-Lizee D, et al. Laparoscopic sacrocolpopexy with two separate meshes along the anterior and posterior vaginal walls for multicompartment pelvic organ prolapse. J Am Assoc Gynecol Laparosc. 2004;11:29–35. 10. Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O’Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011;204:360. 11. Bump R, Anders Mattiasson, Brubaker L, et al. The standardisation of terminology of female pelvic organ prolapse and pelvic floor disfunction. Am J Obstet Gynecol. 1996;175:10–17. 12. Barber M, Brubaker L, Nygaard I, et al. Pelvic Floor Disorders Network. Defining succes after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114:600–609. 13. Barber M, Kuchibhatla M, Pieper C, Bump R. Psychometric evaluation of 2 comprehensive condition-specifc quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001;185: 1388–1395. 14. Rogers R, Kammerer-Doak D, Villarreal A, Coates K, Qualls Clifford. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol. 2001;184:552–558. 15. De Tayrac R, Chauveau-Lambling A, Fernandez D, Fernandez H. Instruments de mesure de la qualite de vie chez les patientes presentant un prolapsus genito-urinaire. J Gynecol Obstet Biol Reprod. 2003;32:503–523. 16. de Tayrac R, Deval B, Fernandez H, Mares P, Mapi Research Institute. Validation linguistique en franc¸ais des versions courtes des questionnaires de sympt^ omes (PFDI-20) et de qualite de vie (PFIQ-7) chez les patientes presentant un trouble de la statique pelvienne. J Gynecol Obstet Biol Reprod. 2007;36:738–748. 17. Barber MD, Walters MD, Bump RC. Short forms of two conditionspecific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005;193: 103–113.
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