- Email: [email protected]
Outcomes associated with the use of midurethral slings for stress incontinence surgery according to the type of hospitalization
International Journal of Gynecology and Obstetrics 129 (2015) 123–127
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Outcomes associated with the use of midurethral slings for stress incontinence surgery according to the type of hospitalization☆ Thibault Thubert a,⁎, Najib Daher b, Aslam Mansoor c, Philippe Debodinance d, Hervé Fernandez e, Xavier Deffieux a a
Service de Gynécologie-Obstétrique et Médecine de la Reproduction, Hôpital Antoine Béclère, Assistance Publique–Hôpitaux de Paris, Clamart 92141, France Département de Gynécologie-Obstétrique, CHU Amiens, Amiens 80054, France Département de Gynécologie-Obstétrique, Centre Hospitalier Paul-Ardier, Issoire 63500, France d Département de Gynécologie Obstétrique, Centre Hospitalier de Dunkerque, Saint-Pol-sur-Mer 59430, France e Service de Gynécologie-Obstétrique, CHU Bicêtre, Assistance Publique–Hôpitaux de Paris, Le Kremlin Bicêtre 94275, France b c
a r t i c l e
i n f o
Article history: Received 12 July 2014 Received in revised form 11 November 2014 Accepted 20 January 2015 Keywords: Ambulatory management Day surgery Inside-out transobturator approach Midurethral sling Outpatient Retropubic sling Stress urinary incontinence
a b s t r a c t Objective: To evaluate the influence of type of hospitalization on outcomes of stress urinary incontinence (SUI) surgery using a midurethral sling procedure. Methods: A retrospective secondary analysis was conducted using data from a prospective multicenter randomized trial of SUI surgery at several sites in France between January 1, 2003, and December 31, 2007. Type of hospitalization was chosen according to the surgeon’s policy. Results: Among 149 participants, 31 (20.8%) were treated as outpatients and 118 (79.2%) as inpatients. Perioperative complications were recorded for 1 (3.2%) outpatient and 12 (10.1%) inpatients (P = 0.388). At 24 months of follow-up, none of 25 outpatients and 6 (5.6%) of 107 inpatients had a positive stress test result (P = 0.497). Dryness was reported at this time point by 22 (88.0%) outpatients and 89 (83.2%) inpatients (P = 0.922). The median satisfaction score (measured by visual analog scale [scores of 0–100]) at 12 months was 100.0 (interquartile range [IQR] 93.5–100.0) among outpatients versus 96.5 (IQR 80.0–100.0; P = 0.003) among inpatients. Similar results were observed at 24 months (P = 0.003). Conclusion: Complication and failure rates were similar in both groups, but satisfaction was higher among outpatients. © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction The midurethral sling (MUS) represents the first-line surgical option for the treatment of women with stress urinary incontinence (SUI) [1]. This minimally invasive treatment can be performed as an outpatient (ambulatory) procedure. A marked uptake in the use of ambulatory MUS to treat SUI has been reported over the past decade. One study [2] estimated that the number of women undergoing such procedures in the USA rose from 34 968 in 1996 to 105 656 in 2006, while another US-based study [3] found that the rate of ambulatory MUS procedures had increased by four times between 2001 and 2009. A recent worldwide survey showed that 84% of urogynecologic surgeons managed transobturator tape procedures through the use of a day-case procedure [4]. Nevertheless, studies regarding the functional outcomes of outpatient versus inpatient procedures for SUI are still lacking [5–7].
☆ Presented at the International Continence Society Annual Meeting; October 20–24, 2014; Rio de Janeiro, Brazil. Abstract 694. ⁎ Corresponding author at: Service de Gynécologie-Obstétrique et Médecine de la Reproduction, Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92140 Clamart, France. Tel.: +33 145374469; fax: +33 145374963. E-mail address: [email protected] (T. Thubert).
Therefore, the aim of the present study was to evaluate the effect of the type of hospitalization on complications and failure rates after MUS-based procedures to treat SUI. 2. Materials and methods The present study was a retrospective secondary analysis of a previous prospective randomized trial comparing two approaches for MUS surgery conducted at multiple sites in France between January 1, 2005, and December 31, 2007 [8]. The clinical trial had been approved by the Comité de protection des personnes, CPP-Hôpital Cochin, Paris, France (no. 2207/15-11-04) and was considered to comply with the generally accepted scientific principles and ethical standards of medical research. Patients were informed about the procedures, the anticipated risks, and the potential complications before surgery; written informed consent was provided by all participants. The randomized controlled trial has been described previously [8]. Briefly, the inclusion criteria were incontinence (SUI or mixed incontinence according to the International Continence Society classification [9]) and planned placement of an MUS (discomfort evaluated using the CONTILIFE questionnaire [10]). Patients had a positive cough stress test result when the bladder was filled with 200–300 mL of saline.
http://dx.doi.org/10.1016/j.ijgo.2014.11.016 0020-7292/© 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
124
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
Table 1 Baseline characteristics of the patients by type of hospitalization.a Characteristic
Outpatients (n = 31)
BMI Age, y Parity Birth weight of first child, gc Postpartum PFMTc Number of PFMT sessionsc Postmenopausal Menopausal treatment MUCP b30 cm H2Oe MUCP, cm H2O Type of surgery Retropubic Transobturator Stage 1 cystocele Stage 2 cystocele Previous urge incontinence Embarrassment related to urge incontinence, VAS Embarrassment related to bladder outlet obstruction, VAS Embarrassment related to stress urinary incontinence, VAS Qmax b15 mL/se
25.0 (22.8–29.2) 25.7 (22.0–29.9) 54.0 (41.5–58.5) 54 (47.0–60.0) 2 (2–3) 2 (2–3) 3400 (3160–3650) 3500 (3150–3822) 13 (44.8) 58 (52.7) 20 (10–20) 20 (15–24) 17 (54.8) 68 (57.6) 5 (29.4) 19 (27.9) 2 (6.4) 18 (15.8) 53 (36–72) 61 (50–69)
0.852b 0.338b 0.283b 0.690b 0.583d 0.692b 0.940d 0.856d 0.325d 0.256b
16 (51.6) 15 (48.4) 5 (16.1) 0 12 (38.7) 45.0 (27.5–82.5)
59 (50.0) 59 (50.0) 7 (5.9) 36 (30.5) 54 (45.8) 50.0 (32.5–70.0)
0.966d 0.966d 0.137d 0.001d 0.677d 0.759b
25.0 (20.0–50.0)
30.0 (10.0–50.0)
0.533b
70.0 (57.5–80.0)
70.0 (50.0–80.0)
0.326b
2 (6.4)
Inpatients (n = 118)
14 (12.3)
P value
0.551d
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); PFMT, pelvic floor muscle training; MUCP, maximal urethral closure pressure; VAS, visual analog scale; Qmax, maximal urethral peak flow. a Values given as median (interquartile range) or number (percentage), unless indicated otherwise. b Welch two-sample t test (Student t test). c Only 29 outpatients and 110 inpatients had given birth previously. d Pearson χ2 test with Yates continuity correction (χ2 test). e Data available for 114 inpatients.
Patients who were to undergo concomitant pelvic organ prolapse surgery or hysterectomy were not included. Other exclusion criteria were pregnancy, history of incontinence surgery, or stage of pelvic organ prolapse higher than 1. A total of 154 women were enrolled in the original study, of whom 149 were considered eligible to participate [8]. Eligible patients were randomly allocated to either an inside-out transobturator approach (TVTO) or a retropubic tension-free vaginal tape (TVT) procedure. At each participating center, the type of hospitalization was chosen according to the surgeon’s policy. Inpatient Table 2 Surgical and discharge characteristics.a Characteristic Anesthesia General Local Spinal Perioperative complicationsc Urethral wound Vesical wound Vaginal wound Operative duration, min Length of stay, d Volume of first micturition, mL Post-void residual volume, mL Discharged with Indwelling urinary catheter Self-catheterization Immediate postoperative pain, VAS
Outpatients (n = 31)
Inpatients (n = 118)
P value
15 (48.3) 13 (41.9) 3 (9.6)
42 (35.6) 13 (11.0) 63 (53.4)
0.273b b0.001b b0.001b
1 (3.2) 0 0 10 (9–20) 0 (0–0) 285 (162–375) 30.0 (14.5–58.5)
0 6 (51) 6 (5.1) 20 (15–25) 1 (1–2) 250 (200–400) 60.0 (20.0–125.0)
0.470b 0.442b 0.442b 0.003d b0.001d 0.859d 0.054d
0 0 20.0 (2.5–45.0)
1 (0.8) 3 (2.6) 10.0 (0.0–30.0)
0.470b 0.858b 0.652d
Abbreviation: VAS, visual analog scale. a Values given as number (percentage) or median (interquartile range), unless indicated otherwise. b Pearson χ2 test with Yates continuity correction (χ2 test). c No cases of obturator hematoma, retzius hematoma, vaginal hematoma, or iliac vessel wound were recorded in either group. d Welch two-sample t test (Student t test).
(conventional) hospitalization was defined as arrival at the hospital on the morning of surgery, with a stay of at least one night after the procedure. Outpatient (ambulatory) hospitalization was defined as arrival at the hospital on the morning of surgery, with discharge a few hours after the procedure if no post-void residual urine. Variables evaluated before hospital discharge were operative pain (assessed using a visual analog scale [VAS]) and post-void residual volume (assessed by bladder catheterization after voiding). The TVTO (Gynecare, Issy-les-Moulineaux, France) procedure was performed in accordance with the technique described by De Leval [11]. The TVT (Gynecare, Issy-les-Moulineaux, France) surgery was performed as described by Ulmsten [12]. The type of anesthesia was chosen according to the surgeon’s policy. Patients underwent follow-up visits at 1 and 3 weeks, and at 6, 12, and 24 months after the procedure [8]. At these visits, severity of urge incontinence, SUI, pain, bladder outlet obstruction, and satisfaction with the procedure were assessed. These variables were evaluated using the VAS (score 0–100). The objective cure rate (negative stress Table 3 Complications and outcomes 1 week and 3 weeks after surgery.a Complication/outcome 1 week after surgery Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Inguinal fold Buttocks 3 weeks after surgery Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Inguinal fold Buttocks Self-catheterization Median duration of self-catheterization, d Urge incontinence Urge incontinence leakage Embarrassment related to urge incontinence, VAS New-onset urge incontinence SUI Embarrassment related to SUI, VAS Embarrassment related to bladder outlet obstruction, VAS New-onset bladder outlet obstruction Level of satisfaction with the procedure Very satisfied Satisfied Dissatisfied Highly dissatisfied Subjective efficacy of the procedure Dry Reduced urinary leakage Unchanged SUI Global satisfaction rating, VAS Vaginal sling erosion
Outpatients (n = 31)
Inpatients (n = 118)
16 (51.6) 11 (35.5) 20.0 (0.0–37.5)
71 (60.2) 46 (39.0) 20.0 (0.0–37.5)
9 (29.0) 3 (9.6) 8 (25.8) 2 (6.4) 7 (22.6) 1 (3.2) 20.0 (20.0–27.5) 3 (9.6) 2 (6.4) 4 (12.8) 0 0 0
37 (31.3) 10 (8.5) 35 (29.7) 7 (5.9) 30 (25.4) 18 (15.2) 30.0 (10.0–43.7) 13 (11.X) 4 (3.4) 23 (19.5) 3 (2.6) 7 (5.9) 5 (4.3)
P value
0.512 b 0.881 b 0.936b 0.975b 0.884b 0.842b 0.843b 0.381b 0.137b 0.279c 0.911b 0.796b 0.558b 0.858b 0.361b b0.001b
6 (19.3) 2 (6.4) 80.0 (42.5–87.5)
35 (29.7) 19 (16.1) 30.0 (20.0–50.0)
0.359b 0.278b 0.124c
2 (6.4) 3 (9.6) 50.0 (25.0–74.0)
10 (8.5) 14 (11.9) 40.0 (20.0–50.0)
N0.99b 0.981b 0.577c
12.5 (1.2–28.7)
10.0 (0.0–22.0)
0.485c
11 (35.5)
43 (36.4)
0.911b 0.736b
21 (67.7) 8 (25.8) 1 (3.2) 1 (3.2)
28 (90.3) 2 (6.4) 1 (3.2) 100.0 (80.0-100.0) 1 (3.2)
78 (66.1) 36 (30.5) 3 (2.6) 1 (0.8)
107 (90.6) 10 (8.5) 1 (0.8) 95.0 (80.0–100.0) 2 (1.7)
0.775b 0.542b 0.883b 0.773c 0.858b
Abbreviations: VAS, visual analog scale; SUI, stress urinary incontinence. a Values given as number (percentage) or median (interquartile range), unless indicated otherwise. b Pearson χ2 test with Yates continuity correction. c Welch two-sample t test (Student t test).
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
test result) and the subjective cure rate (absence of reported leakage and no use of a pad) were also assessed. Overall success of the surgery was defined as no urinary leakage and a negative stress test result. The data were analyzed using SPSS version 18 (SPSS Inc, Chicago, IL, USA). Descriptive statistics were expressed as the median and interquartile range (IQR; 25th–75th percentile). Continuous variables were compared using the Student t test. Qualitative variables were tested using the Pearson χ2 test with Yates continuity correction. P b 0.05 was considered statistically significant. 3. Results Among the 149 women who participated, 31 (20.8%) were outpatients and 118 (79.2%) were inpatients. No statistically significant differences were detected between the two groups, except in the frequency of stage 2 cystocele (Table 1). No loss to follow-up occurred in either group at weeks 1 and 2. Among the 31 outpatients, 30 (96.8%), 28 (90.3%), and 25 (80.6%) returned for follow-up visits at 6, 12, and 24 months, respectively. Of the 118 inpatients, 113 (95.8%), 110 (93.2%), and 107 (90.7%) attended follow-up at 6, 12, and 24 months, respectively. The median operating time was significantly lower for outpatients than for inpatients (P = 0.003) (Table 2). The use of general anesthesia did not differ in the two groups, but local anesthesia was used more frequently among outpatients than among inpatients (P b 0.001), whereas locoregional spinal anesthesia was used more often among inpatients
125
than outpatients (P b 0.001). One (3.2%) outpatient and 7 (5.9%) inpatients required intermittent catheterization or an indwelling urinary catheter at time of discharge (P = 0.883). Although the median postvoid residual volume was lower among outpatients than inpatients, this association did not reach statistical significance (P = 0.054) (Table 2). Perioperative complications were recorded for 1 (3.2%) outpatient and 12 (10.1%) inpatients (P = 0.388). There were no unscheduled hospital admissions among participants after the procedure. The proportions of patients who reported pain or use of pain medication, the severity of pain, and the location of pain did not differ by group at 1 week or at 3 weeks (Table 3). Pain outcomes did not differ between groups at 6, 12, or 24 months (Table 4). The proportions of patients with positive stress test results (i.e. the objective failure rate) were also similar across follow-up (Table 4). The frequencies of bladder outlet obstruction and urge incontinence were also equivalent in both groups (except for urge incontinence at 6 months), irrespective of the timepoint, as was the subjective efficacy of the surgery. At 24 months, vaginal sling erosion had occurred in 1 (3.2%) outpatient and 5 (4.2%) inpatients (P = 0.86). As assessed by the CONTILIFE questionnaire, the participants’ global quality of life had improved between the preoperative consultation and the final follow-up visit. No statistically significant between-group differences were observed in this measure at 1 week and at 6, 12, and 24 months of follow-up (Table 5). Global satisfaction with the procedure at 3 weeks of follow-up was equivalent in both groups
Table 4 Complications and outcomes after 6, 12, and 24 months.a Complication/outcome
Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Buttocks Urge incontinence Embarrassment related to urge incontinence, VAS New-onset urge incontinence SUI Embarrassment related to SUI embarrassment, VAS Bladder outlet obstruction Embarrassment related to bladder outlet obstruction, VAS New-onset bladder outlet obstruction Level of satisfaction with the procedure Very satisfied Satisfied Dissatisfied Highly dissatisfied Subjective efficacy of the procedure Dry Reduced urinary leakage Unchanged SUI Global satisfaction rating, VAS Vaginal sling erosion Hypermobility Positive stress test result
6 months
12 months
Outpatients (n = 30)
Inpatients (n = 113)
7 (23.3) 1 (3.3) 30.0 (10.0–30.0)
16 (14.2) 4 (3.5) 25.0 (10.0–31.2)
2 (6.6) 1 (3.3) 4 (13.2) 3 (9.9) 25.0 (22.5–37.5)
P value
24 months
Outpatients (n = 28)
Inpatients (n = 110)
0.349 c 0.614c 0.903 d
5 (17.8) 2 (7.1) 30.0 (20.0–50.0)
16 (14.5) 4 (3.6) 30.0 (17.5–42.5)
5 (4.4) 1 (0.8) 8 (7.1) 34 (30.0) 30.0 (10.0–50.0)
0.976c 0.888c 0.466c 0.046c 0.908d
1 (3.5) 2 (7.1) 2 (7.1) 5 (17.8) 25.0 (20.0–70.0)
1 (3.3) 1 (3.3) 25 (83.3)
14 (12.4) 11 (9.7) 10.0 (3.5–49.5)
0.270c 0.451c 0.778d
10 (33.3) 12.5 (10.0-50.0)
44 (38.9) 7.5 (0.0–32.5)
6 (20.X)
31 (27.4)
Outpatients (n = 25)
Inpatients (n = 107)
P value
0.888c 0.769c 0.783d
4 (16.0) 1 (4.0) 10.0 (7.5–30.0)
8 (7.4) 1 (0.9) 35.0 (10.0–50.0)
0.343c 0.821c 0.275d
9 (8.2) 1 (0.9) 6 (5.4) 37 (33.6) 30.0 (20.0–50.0)
0.666c 0.196c 0.911c 0.164c 0.715d
1 (4.0) 2 (8.0) 1 (4.0) 3 (12.0) 30.0 (20.0–30.0)
3 (2.7) 0 3 (2.7) 34 (31.8) 30.0 (20.0–57.5)
0.738c 0.041c 0.738c 0.083c 0.144d
2 (7.1) 2 (7.1) 30.0 (25.0–35.0)
13 (11.8) 10 (9.1) 6.5 (2.7–34.2)
0.712c 0.960c 0.592d
2 (8.0) 3 (12.0) 25.0 (17.5–32.5)
13 (12.1) 17 (15.9) 20.0 (10.0–45.0)
0.811c 0.858c 0.844d
0.725c 0.815c
11 (39.3) 10.0 (1.0–15.0)
52 (47.3) 10.0 (0.0–22.5)
0.586c 0.641d
11 (44.0) 10.0 (2.5–20.0)
47 (43.9) 5.0 (0.0–20.0)
0.828c 0.726d
0.553c
7 (25.0)
40 (36.4)
0.363c
7 (28.0)
33 (30.8)
0.971c
0.669c 23 (76.6) 6 (20.X) 1 (3.3) 0
74 (65.5) 31 (27.4) 7 (6.2) 1 (0.8)
28 (93.3) 2 (6.6) 0 98.5 (90.0–100.0) 0 4 (13.2) 0
101 (89.4) 12 (10.6) 0 98.0 (80.0–100.0) 0 19 (16.8) 6 (5.3)
Abbreviations: VAS, visual analog scale; SUI, stress urinary incontinence. a Values given as number (percentage) or median (interquartile range). b Numbers of patients fell over time as a result of loss to follow-up. c Pearson χ2 test with Yates continuity correction (χ2 test). d Welch two-sample t test (Student t test). e Data available for 107 patients.
0.762c 0.762c N0.99c 0.151d N0.99c 0.855c 0.437c
P value
0.174c 24 (85.8) 4 (14.2) 0 0
72 (65.4) 29 (26.4) 6 (5.4) 3 (2.7)
27 (96.5) 1 (3.5) 0 100.0 (93.5–100.0) 0 2 (7.1) 0
97 (88.2) 10 (9.1) 3 (2.7) 96.5 (80.0–100.0) 0 16 (14.5) 6 (5.4)
0.347c 0.567c 0.875c 0.003d N0.99c 0.469c 0.206c
0.271c 22 (88.0) 3 (12.0) 0 0
75 (70.1) 23 (21.5) 5 (4.7) 4 (3.7)
22 (88.0) 3 (12.0) 0 95.0 (90.0–100.0) 0 3 (12.0) 0
89 (83.2) 15 (14.0) 3 (2.7) 95.0 (80.0-100.0) 3 (2.7) 21 (19.6) 6 (5.6)e
0.922c 0.953c 0.919c 0.003d 0.919c 0.547c 0.497c
126
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
Table 5 Question 28 of CONTILIFE questionnaire.a,b
Quality of life at 1-week follow-upd 1 2 3 4 5 Quality of life at 6-month follow-upe 1 2 3 4 5 Quality of life at 12-month follow-upf 1 2 3 4 5 Quality of life at 24-month follow-upg 1 2 3 4 5
Outpatients
Inpatients
4 (14.8) 9 (33.3) 12 (44.4) 2 (7.4) 0
13 (12) 32 (29.6) 51 (47.2) 10 (9.3) 2 (1.8)
0 1 (4) 1 (4) 7 (28) 16 (64)
1 (1) 2 (2) 7 (6.9) 32 (31.4) 60 (58.8)
0 1 (4.3) 0 6 (26.1) 16 (69.6)
1 (1) 1 (1) 6 (6.2) 28 (29.2) 60 (62.5)
0 0 0 5 (25) 15 (75)
0 0 9 (9.6) 22 (23.4) 63 (67.0)
P value c 0.932
0.906
0.542
0.322
a Question 28 of the CONTILIFE questionnaire evaluates the global quality of life using a visual analog scale, in which a score of 1 corresponds to a poor quality of life and a score of 5 to a good quality of life. b Values are given as number (percentage) unless indicated otherwise. c Pearson χ2 test with Yates continuity correction (χ2 test). d Outpatients n = 27; inpatients n = 108. e Outpatients n = 25; inpatients n = 102. f Outpatients n = 23; inpatients n = 96. g Outpatients n = 20; inpatients n = 94.
(P = 0.736) (Table 3). By contrast, the VAS score for this measure was higher in outpatients than inpatients at both 12 and 24 months of follow-up (P = 0.003 for both) (Table 4). Before surgery, the urodynamic characteristics—median maximal urethral closure pressure (MUCP), the proportion of patients with a maximal urethral flow (Qmax) of less than 15 mL/s, and the prevalence of MUCP less than or equal to 30 cm H2O—were equivalent in both groups (Table 1). Neither of the two outpatients with a Qmax of less than 15 mL/s were discharged with an indwelling catheter. Among the 14 inpatients with a Qmax of less than 15 mL/s, three were discharged with an indwelling catheter. The preoperative Qmax and post-void residuals were comparable in both groups (data not shown). 4. Discussion The present study has assessed the influence of the type of hospitalization on the outcome of minimally invasive MUS surgery in patients with SUI. Although the objective and subjective successful outcome rates were similar in participants treated as inpatients or outpatients, ambulatory management was associated with better subjective satisfaction at 12 and 24 months of follow-up. The complication rate was similar among inpatients and outpatients. There were no unscheduled inpatient admissions after the procedure. Although the original publication describing the TVT procedure suggested the use of ambulatory management [12], in the early years of SUI surgery most procedures required hospitalization. However, in recent years there has been an increasing trend toward the use of ambulatory management for SUI surgery [2,3,13]. Only a few studies have specifically analyzed ambulatory SUI procedures, and most published reports describing the use of MUS procedures involved inpatient management or did not report the length of the patients' stay. A prospective study analyzing the feasibility of day-case SUI surgery [14] included 132 patients who underwent a TVT procedure, of whom only 2 (1.6%) required
hospitalization while 111 (84.1%) had no complication. A retrospective study [7] reported that 22.1% (37/167) of patients undergoing a transobturator tape procedure required hospitalization. Among these patients, 20 did not achieve a satisfactory postoperative voiding pattern within the expected period, and three had postoperative pain, vaginal bleeding, and nausea or vomiting [7]. In some cases of unexpected hospitalization in that study, the reason for an extended hospital stay after a MUS procedure was the need for prolonged bladder catheterization. Most of these cases might have been avoided if self-catheterization had been taught preoperatively. Hong et al. [15] showed that maximal urethral flow was the best predictive factor for postoperative urinary retention following TVT procedures. A preoperative peak urinary flow of less than 15 mL/s was associated with a urinary retention rate equal to 27.3%. Because of discrepancies in the definitions of post-voiding dysfunction used in various published studies, and the low rate of occurrence of this syndrome (2.5%–24% [16]), it is clearly difficult to determine such predictive factors. In the present study, a peak urinary flow below 15 mL/s was not correlated with post-MUS urinary retention. The level of satisfaction in patients having undergone a SUI procedure is high. Using a Likert scale approach, Van der Vaart et al. [14] found that more than 98.5% of their patients were satisfied. The factors associated with a negative recommendation for day surgery were not related to the surgeon's performance, but to the patients' appreciation of the private clinic staff. In the present study, the immediate VAS satisfaction was equivalent in patients treated as inpatients and outpatients. The pain management of ambulatory patients appeared to be the same in both populations, and the mean severity of pain was equivalent in both groups. However, the overall VAS satisfaction was higher in the ambulatory group than in the conventional hospitalization group at 12 and 24 months of follow-up. As similar objective cure and complication rates were found at 12 and 24 months follow-up, ambulatory management could have had long-term positive effects. The present study has limitations. It is a retrospective study based on the secondary analysis of a previous prospective randomized trial, and the number of patients included in the ambulatory population is small. The small number of outpatients did not allow a predictive factor for unscheduled hospitalization to be determined. Another limitation of the study was that patients from the previous trial were not randomized for type of hospitalization and type of hospitalization was chosen according to the surgeon’s policy. A prospective randomized trial to compare the influence of hospitalization with additional criteria should be performed. Preoperative and postoperative anxiety, number of preoperative and postoperative medical visits, timing between initial visit and operative day, number of unscheduled visits before surgery, number of cancelled procedures, and number of patients lost to follow-up after surgery would have to be assessed. Any additional prospective study must include a broad population and focus on the impact of the type of hospitalization to confirm and complete the findings of the present study. In conclusion, the present secondary analysis of a previous prospective trial has shown that the type of hospitalization has no influence on the outcome. Ambulatory management—which is likely to become the gold standard in the future—does not appear to be associated with any degradation in the long-term outcome of surgical procedures for SUI. Conflict of interest The authors have no conflicts of interest. References [1] Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, et al. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol 2010;151(1):14–9. [2] Erekson EA, Lopes VV, Raker CA, Sung VW. Ambulatory procedures for female pelvic floor disorders in the United States. Am J Obstet Gynecol 2010;203(5):497.e1–5.
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127 [3] Suskind AM, Kaufman SR, Dunn RL, Stoffel JT, Clemens JQ, Hollenbeck BK. Populationbased trends in ambulatory surgery for urinary incontinence. Int Urogynecol J 2013; 24(2):207–11. [4] Abdel-Fattah M, Ramsay I. Transobturator tension free vaginal tapes: are they the way forward in the surgical treatment of urodynamic stress incontinence? Int J Surg 2007;5(1):3–10. [5] Khandwala S, Jayachandran C. TVT-Secur in office sling procedure under local anesthesia: a prospective 2-year analysis. Female Pelvic Med Reconstr Surg 2012;18(4):233–8. [6] Barron KI, Savageau JA, Young SB, Labin LC, Morse AN. Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(6):570–5. [7] Sivanesan K, Fattah MA, Ramsay I. Transobturator tape as a day surgery procedure: a case control study. Int J Surg 2007;5(3):152–4. [8] Deffieux X, Daher N, Mansoor A, Debodinance P, Muhlstein J, Fernandez H. Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up. Int Urogynecol J 2010;21(11):1337–45. [9] Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Subcommittee of the International Continence Society. Neurourol Urodyn 2002;21(2): 167–78.
127
[10] Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European psychometric validation of the CONTILIFE: a Quality of Life questionnaire for urinary incontinence. Eur Urol 2003;43(4):391–404. [11] De Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44(6): 724–30. [12] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7(2):81–5. [13] Rogo-Gupta L, Litwin MS, Saigal CS, Anger JT. Urologic Diseases in America Project. Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002–2007. Urology 2013;82(1):38–41. [14] van der Vaart CH, Lamers BH, Heintz AP. Feasibility and patient satisfaction with pelvic organ prolapse and urinary incontinence day surgery. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(5):531–6. [15] Hong B, Park S, Kim HS, Choo MS. Factors predictive of urinary retention after a tension-free vaginal tape procedure for female stress urinary incontinence. J Urol 2003;170(3):852–6. [16] Wang KH, Wang KH, Neimark M, Davila GW. Voiding dysfunction following TVT procedure. Int Urogynecol J Pelvic Floor Dysfunct 2002;13(6):353–7.
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Outcomes associated with the use of midurethral slings for stress incontinence surgery according to the type of hospitalization☆ Thibault Thubert a,⁎, Najib Daher b, Aslam Mansoor c, Philippe Debodinance d, Hervé Fernandez e, Xavier Deffieux a a
Service de Gynécologie-Obstétrique et Médecine de la Reproduction, Hôpital Antoine Béclère, Assistance Publique–Hôpitaux de Paris, Clamart 92141, France Département de Gynécologie-Obstétrique, CHU Amiens, Amiens 80054, France Département de Gynécologie-Obstétrique, Centre Hospitalier Paul-Ardier, Issoire 63500, France d Département de Gynécologie Obstétrique, Centre Hospitalier de Dunkerque, Saint-Pol-sur-Mer 59430, France e Service de Gynécologie-Obstétrique, CHU Bicêtre, Assistance Publique–Hôpitaux de Paris, Le Kremlin Bicêtre 94275, France b c
a r t i c l e
i n f o
Article history: Received 12 July 2014 Received in revised form 11 November 2014 Accepted 20 January 2015 Keywords: Ambulatory management Day surgery Inside-out transobturator approach Midurethral sling Outpatient Retropubic sling Stress urinary incontinence
a b s t r a c t Objective: To evaluate the influence of type of hospitalization on outcomes of stress urinary incontinence (SUI) surgery using a midurethral sling procedure. Methods: A retrospective secondary analysis was conducted using data from a prospective multicenter randomized trial of SUI surgery at several sites in France between January 1, 2003, and December 31, 2007. Type of hospitalization was chosen according to the surgeon’s policy. Results: Among 149 participants, 31 (20.8%) were treated as outpatients and 118 (79.2%) as inpatients. Perioperative complications were recorded for 1 (3.2%) outpatient and 12 (10.1%) inpatients (P = 0.388). At 24 months of follow-up, none of 25 outpatients and 6 (5.6%) of 107 inpatients had a positive stress test result (P = 0.497). Dryness was reported at this time point by 22 (88.0%) outpatients and 89 (83.2%) inpatients (P = 0.922). The median satisfaction score (measured by visual analog scale [scores of 0–100]) at 12 months was 100.0 (interquartile range [IQR] 93.5–100.0) among outpatients versus 96.5 (IQR 80.0–100.0; P = 0.003) among inpatients. Similar results were observed at 24 months (P = 0.003). Conclusion: Complication and failure rates were similar in both groups, but satisfaction was higher among outpatients. © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction The midurethral sling (MUS) represents the first-line surgical option for the treatment of women with stress urinary incontinence (SUI) [1]. This minimally invasive treatment can be performed as an outpatient (ambulatory) procedure. A marked uptake in the use of ambulatory MUS to treat SUI has been reported over the past decade. One study [2] estimated that the number of women undergoing such procedures in the USA rose from 34 968 in 1996 to 105 656 in 2006, while another US-based study [3] found that the rate of ambulatory MUS procedures had increased by four times between 2001 and 2009. A recent worldwide survey showed that 84% of urogynecologic surgeons managed transobturator tape procedures through the use of a day-case procedure [4]. Nevertheless, studies regarding the functional outcomes of outpatient versus inpatient procedures for SUI are still lacking [5–7].
☆ Presented at the International Continence Society Annual Meeting; October 20–24, 2014; Rio de Janeiro, Brazil. Abstract 694. ⁎ Corresponding author at: Service de Gynécologie-Obstétrique et Médecine de la Reproduction, Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92140 Clamart, France. Tel.: +33 145374469; fax: +33 145374963. E-mail address: [email protected] (T. Thubert).
Therefore, the aim of the present study was to evaluate the effect of the type of hospitalization on complications and failure rates after MUS-based procedures to treat SUI. 2. Materials and methods The present study was a retrospective secondary analysis of a previous prospective randomized trial comparing two approaches for MUS surgery conducted at multiple sites in France between January 1, 2005, and December 31, 2007 [8]. The clinical trial had been approved by the Comité de protection des personnes, CPP-Hôpital Cochin, Paris, France (no. 2207/15-11-04) and was considered to comply with the generally accepted scientific principles and ethical standards of medical research. Patients were informed about the procedures, the anticipated risks, and the potential complications before surgery; written informed consent was provided by all participants. The randomized controlled trial has been described previously [8]. Briefly, the inclusion criteria were incontinence (SUI or mixed incontinence according to the International Continence Society classification [9]) and planned placement of an MUS (discomfort evaluated using the CONTILIFE questionnaire [10]). Patients had a positive cough stress test result when the bladder was filled with 200–300 mL of saline.
http://dx.doi.org/10.1016/j.ijgo.2014.11.016 0020-7292/© 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
124
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
Table 1 Baseline characteristics of the patients by type of hospitalization.a Characteristic
Outpatients (n = 31)
BMI Age, y Parity Birth weight of first child, gc Postpartum PFMTc Number of PFMT sessionsc Postmenopausal Menopausal treatment MUCP b30 cm H2Oe MUCP, cm H2O Type of surgery Retropubic Transobturator Stage 1 cystocele Stage 2 cystocele Previous urge incontinence Embarrassment related to urge incontinence, VAS Embarrassment related to bladder outlet obstruction, VAS Embarrassment related to stress urinary incontinence, VAS Qmax b15 mL/se
25.0 (22.8–29.2) 25.7 (22.0–29.9) 54.0 (41.5–58.5) 54 (47.0–60.0) 2 (2–3) 2 (2–3) 3400 (3160–3650) 3500 (3150–3822) 13 (44.8) 58 (52.7) 20 (10–20) 20 (15–24) 17 (54.8) 68 (57.6) 5 (29.4) 19 (27.9) 2 (6.4) 18 (15.8) 53 (36–72) 61 (50–69)
0.852b 0.338b 0.283b 0.690b 0.583d 0.692b 0.940d 0.856d 0.325d 0.256b
16 (51.6) 15 (48.4) 5 (16.1) 0 12 (38.7) 45.0 (27.5–82.5)
59 (50.0) 59 (50.0) 7 (5.9) 36 (30.5) 54 (45.8) 50.0 (32.5–70.0)
0.966d 0.966d 0.137d 0.001d 0.677d 0.759b
25.0 (20.0–50.0)
30.0 (10.0–50.0)
0.533b
70.0 (57.5–80.0)
70.0 (50.0–80.0)
0.326b
2 (6.4)
Inpatients (n = 118)
14 (12.3)
P value
0.551d
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); PFMT, pelvic floor muscle training; MUCP, maximal urethral closure pressure; VAS, visual analog scale; Qmax, maximal urethral peak flow. a Values given as median (interquartile range) or number (percentage), unless indicated otherwise. b Welch two-sample t test (Student t test). c Only 29 outpatients and 110 inpatients had given birth previously. d Pearson χ2 test with Yates continuity correction (χ2 test). e Data available for 114 inpatients.
Patients who were to undergo concomitant pelvic organ prolapse surgery or hysterectomy were not included. Other exclusion criteria were pregnancy, history of incontinence surgery, or stage of pelvic organ prolapse higher than 1. A total of 154 women were enrolled in the original study, of whom 149 were considered eligible to participate [8]. Eligible patients were randomly allocated to either an inside-out transobturator approach (TVTO) or a retropubic tension-free vaginal tape (TVT) procedure. At each participating center, the type of hospitalization was chosen according to the surgeon’s policy. Inpatient Table 2 Surgical and discharge characteristics.a Characteristic Anesthesia General Local Spinal Perioperative complicationsc Urethral wound Vesical wound Vaginal wound Operative duration, min Length of stay, d Volume of first micturition, mL Post-void residual volume, mL Discharged with Indwelling urinary catheter Self-catheterization Immediate postoperative pain, VAS
Outpatients (n = 31)
Inpatients (n = 118)
P value
15 (48.3) 13 (41.9) 3 (9.6)
42 (35.6) 13 (11.0) 63 (53.4)
0.273b b0.001b b0.001b
1 (3.2) 0 0 10 (9–20) 0 (0–0) 285 (162–375) 30.0 (14.5–58.5)
0 6 (51) 6 (5.1) 20 (15–25) 1 (1–2) 250 (200–400) 60.0 (20.0–125.0)
0.470b 0.442b 0.442b 0.003d b0.001d 0.859d 0.054d
0 0 20.0 (2.5–45.0)
1 (0.8) 3 (2.6) 10.0 (0.0–30.0)
0.470b 0.858b 0.652d
Abbreviation: VAS, visual analog scale. a Values given as number (percentage) or median (interquartile range), unless indicated otherwise. b Pearson χ2 test with Yates continuity correction (χ2 test). c No cases of obturator hematoma, retzius hematoma, vaginal hematoma, or iliac vessel wound were recorded in either group. d Welch two-sample t test (Student t test).
(conventional) hospitalization was defined as arrival at the hospital on the morning of surgery, with a stay of at least one night after the procedure. Outpatient (ambulatory) hospitalization was defined as arrival at the hospital on the morning of surgery, with discharge a few hours after the procedure if no post-void residual urine. Variables evaluated before hospital discharge were operative pain (assessed using a visual analog scale [VAS]) and post-void residual volume (assessed by bladder catheterization after voiding). The TVTO (Gynecare, Issy-les-Moulineaux, France) procedure was performed in accordance with the technique described by De Leval [11]. The TVT (Gynecare, Issy-les-Moulineaux, France) surgery was performed as described by Ulmsten [12]. The type of anesthesia was chosen according to the surgeon’s policy. Patients underwent follow-up visits at 1 and 3 weeks, and at 6, 12, and 24 months after the procedure [8]. At these visits, severity of urge incontinence, SUI, pain, bladder outlet obstruction, and satisfaction with the procedure were assessed. These variables were evaluated using the VAS (score 0–100). The objective cure rate (negative stress Table 3 Complications and outcomes 1 week and 3 weeks after surgery.a Complication/outcome 1 week after surgery Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Inguinal fold Buttocks 3 weeks after surgery Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Inguinal fold Buttocks Self-catheterization Median duration of self-catheterization, d Urge incontinence Urge incontinence leakage Embarrassment related to urge incontinence, VAS New-onset urge incontinence SUI Embarrassment related to SUI, VAS Embarrassment related to bladder outlet obstruction, VAS New-onset bladder outlet obstruction Level of satisfaction with the procedure Very satisfied Satisfied Dissatisfied Highly dissatisfied Subjective efficacy of the procedure Dry Reduced urinary leakage Unchanged SUI Global satisfaction rating, VAS Vaginal sling erosion
Outpatients (n = 31)
Inpatients (n = 118)
16 (51.6) 11 (35.5) 20.0 (0.0–37.5)
71 (60.2) 46 (39.0) 20.0 (0.0–37.5)
9 (29.0) 3 (9.6) 8 (25.8) 2 (6.4) 7 (22.6) 1 (3.2) 20.0 (20.0–27.5) 3 (9.6) 2 (6.4) 4 (12.8) 0 0 0
37 (31.3) 10 (8.5) 35 (29.7) 7 (5.9) 30 (25.4) 18 (15.2) 30.0 (10.0–43.7) 13 (11.X) 4 (3.4) 23 (19.5) 3 (2.6) 7 (5.9) 5 (4.3)
P value
0.512 b 0.881 b 0.936b 0.975b 0.884b 0.842b 0.843b 0.381b 0.137b 0.279c 0.911b 0.796b 0.558b 0.858b 0.361b b0.001b
6 (19.3) 2 (6.4) 80.0 (42.5–87.5)
35 (29.7) 19 (16.1) 30.0 (20.0–50.0)
0.359b 0.278b 0.124c
2 (6.4) 3 (9.6) 50.0 (25.0–74.0)
10 (8.5) 14 (11.9) 40.0 (20.0–50.0)
N0.99b 0.981b 0.577c
12.5 (1.2–28.7)
10.0 (0.0–22.0)
0.485c
11 (35.5)
43 (36.4)
0.911b 0.736b
21 (67.7) 8 (25.8) 1 (3.2) 1 (3.2)
28 (90.3) 2 (6.4) 1 (3.2) 100.0 (80.0-100.0) 1 (3.2)
78 (66.1) 36 (30.5) 3 (2.6) 1 (0.8)
107 (90.6) 10 (8.5) 1 (0.8) 95.0 (80.0–100.0) 2 (1.7)
0.775b 0.542b 0.883b 0.773c 0.858b
Abbreviations: VAS, visual analog scale; SUI, stress urinary incontinence. a Values given as number (percentage) or median (interquartile range), unless indicated otherwise. b Pearson χ2 test with Yates continuity correction. c Welch two-sample t test (Student t test).
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
test result) and the subjective cure rate (absence of reported leakage and no use of a pad) were also assessed. Overall success of the surgery was defined as no urinary leakage and a negative stress test result. The data were analyzed using SPSS version 18 (SPSS Inc, Chicago, IL, USA). Descriptive statistics were expressed as the median and interquartile range (IQR; 25th–75th percentile). Continuous variables were compared using the Student t test. Qualitative variables were tested using the Pearson χ2 test with Yates continuity correction. P b 0.05 was considered statistically significant. 3. Results Among the 149 women who participated, 31 (20.8%) were outpatients and 118 (79.2%) were inpatients. No statistically significant differences were detected between the two groups, except in the frequency of stage 2 cystocele (Table 1). No loss to follow-up occurred in either group at weeks 1 and 2. Among the 31 outpatients, 30 (96.8%), 28 (90.3%), and 25 (80.6%) returned for follow-up visits at 6, 12, and 24 months, respectively. Of the 118 inpatients, 113 (95.8%), 110 (93.2%), and 107 (90.7%) attended follow-up at 6, 12, and 24 months, respectively. The median operating time was significantly lower for outpatients than for inpatients (P = 0.003) (Table 2). The use of general anesthesia did not differ in the two groups, but local anesthesia was used more frequently among outpatients than among inpatients (P b 0.001), whereas locoregional spinal anesthesia was used more often among inpatients
125
than outpatients (P b 0.001). One (3.2%) outpatient and 7 (5.9%) inpatients required intermittent catheterization or an indwelling urinary catheter at time of discharge (P = 0.883). Although the median postvoid residual volume was lower among outpatients than inpatients, this association did not reach statistical significance (P = 0.054) (Table 2). Perioperative complications were recorded for 1 (3.2%) outpatient and 12 (10.1%) inpatients (P = 0.388). There were no unscheduled hospital admissions among participants after the procedure. The proportions of patients who reported pain or use of pain medication, the severity of pain, and the location of pain did not differ by group at 1 week or at 3 weeks (Table 3). Pain outcomes did not differ between groups at 6, 12, or 24 months (Table 4). The proportions of patients with positive stress test results (i.e. the objective failure rate) were also similar across follow-up (Table 4). The frequencies of bladder outlet obstruction and urge incontinence were also equivalent in both groups (except for urge incontinence at 6 months), irrespective of the timepoint, as was the subjective efficacy of the surgery. At 24 months, vaginal sling erosion had occurred in 1 (3.2%) outpatient and 5 (4.2%) inpatients (P = 0.86). As assessed by the CONTILIFE questionnaire, the participants’ global quality of life had improved between the preoperative consultation and the final follow-up visit. No statistically significant between-group differences were observed in this measure at 1 week and at 6, 12, and 24 months of follow-up (Table 5). Global satisfaction with the procedure at 3 weeks of follow-up was equivalent in both groups
Table 4 Complications and outcomes after 6, 12, and 24 months.a Complication/outcome
Pain reported by patient Use of pain medication Severity of pain, VAS Location of pain Abdominal Vaginal Buttocks Urge incontinence Embarrassment related to urge incontinence, VAS New-onset urge incontinence SUI Embarrassment related to SUI embarrassment, VAS Bladder outlet obstruction Embarrassment related to bladder outlet obstruction, VAS New-onset bladder outlet obstruction Level of satisfaction with the procedure Very satisfied Satisfied Dissatisfied Highly dissatisfied Subjective efficacy of the procedure Dry Reduced urinary leakage Unchanged SUI Global satisfaction rating, VAS Vaginal sling erosion Hypermobility Positive stress test result
6 months
12 months
Outpatients (n = 30)
Inpatients (n = 113)
7 (23.3) 1 (3.3) 30.0 (10.0–30.0)
16 (14.2) 4 (3.5) 25.0 (10.0–31.2)
2 (6.6) 1 (3.3) 4 (13.2) 3 (9.9) 25.0 (22.5–37.5)
P value
24 months
Outpatients (n = 28)
Inpatients (n = 110)
0.349 c 0.614c 0.903 d
5 (17.8) 2 (7.1) 30.0 (20.0–50.0)
16 (14.5) 4 (3.6) 30.0 (17.5–42.5)
5 (4.4) 1 (0.8) 8 (7.1) 34 (30.0) 30.0 (10.0–50.0)
0.976c 0.888c 0.466c 0.046c 0.908d
1 (3.5) 2 (7.1) 2 (7.1) 5 (17.8) 25.0 (20.0–70.0)
1 (3.3) 1 (3.3) 25 (83.3)
14 (12.4) 11 (9.7) 10.0 (3.5–49.5)
0.270c 0.451c 0.778d
10 (33.3) 12.5 (10.0-50.0)
44 (38.9) 7.5 (0.0–32.5)
6 (20.X)
31 (27.4)
Outpatients (n = 25)
Inpatients (n = 107)
P value
0.888c 0.769c 0.783d
4 (16.0) 1 (4.0) 10.0 (7.5–30.0)
8 (7.4) 1 (0.9) 35.0 (10.0–50.0)
0.343c 0.821c 0.275d
9 (8.2) 1 (0.9) 6 (5.4) 37 (33.6) 30.0 (20.0–50.0)
0.666c 0.196c 0.911c 0.164c 0.715d
1 (4.0) 2 (8.0) 1 (4.0) 3 (12.0) 30.0 (20.0–30.0)
3 (2.7) 0 3 (2.7) 34 (31.8) 30.0 (20.0–57.5)
0.738c 0.041c 0.738c 0.083c 0.144d
2 (7.1) 2 (7.1) 30.0 (25.0–35.0)
13 (11.8) 10 (9.1) 6.5 (2.7–34.2)
0.712c 0.960c 0.592d
2 (8.0) 3 (12.0) 25.0 (17.5–32.5)
13 (12.1) 17 (15.9) 20.0 (10.0–45.0)
0.811c 0.858c 0.844d
0.725c 0.815c
11 (39.3) 10.0 (1.0–15.0)
52 (47.3) 10.0 (0.0–22.5)
0.586c 0.641d
11 (44.0) 10.0 (2.5–20.0)
47 (43.9) 5.0 (0.0–20.0)
0.828c 0.726d
0.553c
7 (25.0)
40 (36.4)
0.363c
7 (28.0)
33 (30.8)
0.971c
0.669c 23 (76.6) 6 (20.X) 1 (3.3) 0
74 (65.5) 31 (27.4) 7 (6.2) 1 (0.8)
28 (93.3) 2 (6.6) 0 98.5 (90.0–100.0) 0 4 (13.2) 0
101 (89.4) 12 (10.6) 0 98.0 (80.0–100.0) 0 19 (16.8) 6 (5.3)
Abbreviations: VAS, visual analog scale; SUI, stress urinary incontinence. a Values given as number (percentage) or median (interquartile range). b Numbers of patients fell over time as a result of loss to follow-up. c Pearson χ2 test with Yates continuity correction (χ2 test). d Welch two-sample t test (Student t test). e Data available for 107 patients.
0.762c 0.762c N0.99c 0.151d N0.99c 0.855c 0.437c
P value
0.174c 24 (85.8) 4 (14.2) 0 0
72 (65.4) 29 (26.4) 6 (5.4) 3 (2.7)
27 (96.5) 1 (3.5) 0 100.0 (93.5–100.0) 0 2 (7.1) 0
97 (88.2) 10 (9.1) 3 (2.7) 96.5 (80.0–100.0) 0 16 (14.5) 6 (5.4)
0.347c 0.567c 0.875c 0.003d N0.99c 0.469c 0.206c
0.271c 22 (88.0) 3 (12.0) 0 0
75 (70.1) 23 (21.5) 5 (4.7) 4 (3.7)
22 (88.0) 3 (12.0) 0 95.0 (90.0–100.0) 0 3 (12.0) 0
89 (83.2) 15 (14.0) 3 (2.7) 95.0 (80.0-100.0) 3 (2.7) 21 (19.6) 6 (5.6)e
0.922c 0.953c 0.919c 0.003d 0.919c 0.547c 0.497c
126
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127
Table 5 Question 28 of CONTILIFE questionnaire.a,b
Quality of life at 1-week follow-upd 1 2 3 4 5 Quality of life at 6-month follow-upe 1 2 3 4 5 Quality of life at 12-month follow-upf 1 2 3 4 5 Quality of life at 24-month follow-upg 1 2 3 4 5
Outpatients
Inpatients
4 (14.8) 9 (33.3) 12 (44.4) 2 (7.4) 0
13 (12) 32 (29.6) 51 (47.2) 10 (9.3) 2 (1.8)
0 1 (4) 1 (4) 7 (28) 16 (64)
1 (1) 2 (2) 7 (6.9) 32 (31.4) 60 (58.8)
0 1 (4.3) 0 6 (26.1) 16 (69.6)
1 (1) 1 (1) 6 (6.2) 28 (29.2) 60 (62.5)
0 0 0 5 (25) 15 (75)
0 0 9 (9.6) 22 (23.4) 63 (67.0)
P value c 0.932
0.906
0.542
0.322
a Question 28 of the CONTILIFE questionnaire evaluates the global quality of life using a visual analog scale, in which a score of 1 corresponds to a poor quality of life and a score of 5 to a good quality of life. b Values are given as number (percentage) unless indicated otherwise. c Pearson χ2 test with Yates continuity correction (χ2 test). d Outpatients n = 27; inpatients n = 108. e Outpatients n = 25; inpatients n = 102. f Outpatients n = 23; inpatients n = 96. g Outpatients n = 20; inpatients n = 94.
(P = 0.736) (Table 3). By contrast, the VAS score for this measure was higher in outpatients than inpatients at both 12 and 24 months of follow-up (P = 0.003 for both) (Table 4). Before surgery, the urodynamic characteristics—median maximal urethral closure pressure (MUCP), the proportion of patients with a maximal urethral flow (Qmax) of less than 15 mL/s, and the prevalence of MUCP less than or equal to 30 cm H2O—were equivalent in both groups (Table 1). Neither of the two outpatients with a Qmax of less than 15 mL/s were discharged with an indwelling catheter. Among the 14 inpatients with a Qmax of less than 15 mL/s, three were discharged with an indwelling catheter. The preoperative Qmax and post-void residuals were comparable in both groups (data not shown). 4. Discussion The present study has assessed the influence of the type of hospitalization on the outcome of minimally invasive MUS surgery in patients with SUI. Although the objective and subjective successful outcome rates were similar in participants treated as inpatients or outpatients, ambulatory management was associated with better subjective satisfaction at 12 and 24 months of follow-up. The complication rate was similar among inpatients and outpatients. There were no unscheduled inpatient admissions after the procedure. Although the original publication describing the TVT procedure suggested the use of ambulatory management [12], in the early years of SUI surgery most procedures required hospitalization. However, in recent years there has been an increasing trend toward the use of ambulatory management for SUI surgery [2,3,13]. Only a few studies have specifically analyzed ambulatory SUI procedures, and most published reports describing the use of MUS procedures involved inpatient management or did not report the length of the patients' stay. A prospective study analyzing the feasibility of day-case SUI surgery [14] included 132 patients who underwent a TVT procedure, of whom only 2 (1.6%) required
hospitalization while 111 (84.1%) had no complication. A retrospective study [7] reported that 22.1% (37/167) of patients undergoing a transobturator tape procedure required hospitalization. Among these patients, 20 did not achieve a satisfactory postoperative voiding pattern within the expected period, and three had postoperative pain, vaginal bleeding, and nausea or vomiting [7]. In some cases of unexpected hospitalization in that study, the reason for an extended hospital stay after a MUS procedure was the need for prolonged bladder catheterization. Most of these cases might have been avoided if self-catheterization had been taught preoperatively. Hong et al. [15] showed that maximal urethral flow was the best predictive factor for postoperative urinary retention following TVT procedures. A preoperative peak urinary flow of less than 15 mL/s was associated with a urinary retention rate equal to 27.3%. Because of discrepancies in the definitions of post-voiding dysfunction used in various published studies, and the low rate of occurrence of this syndrome (2.5%–24% [16]), it is clearly difficult to determine such predictive factors. In the present study, a peak urinary flow below 15 mL/s was not correlated with post-MUS urinary retention. The level of satisfaction in patients having undergone a SUI procedure is high. Using a Likert scale approach, Van der Vaart et al. [14] found that more than 98.5% of their patients were satisfied. The factors associated with a negative recommendation for day surgery were not related to the surgeon's performance, but to the patients' appreciation of the private clinic staff. In the present study, the immediate VAS satisfaction was equivalent in patients treated as inpatients and outpatients. The pain management of ambulatory patients appeared to be the same in both populations, and the mean severity of pain was equivalent in both groups. However, the overall VAS satisfaction was higher in the ambulatory group than in the conventional hospitalization group at 12 and 24 months of follow-up. As similar objective cure and complication rates were found at 12 and 24 months follow-up, ambulatory management could have had long-term positive effects. The present study has limitations. It is a retrospective study based on the secondary analysis of a previous prospective randomized trial, and the number of patients included in the ambulatory population is small. The small number of outpatients did not allow a predictive factor for unscheduled hospitalization to be determined. Another limitation of the study was that patients from the previous trial were not randomized for type of hospitalization and type of hospitalization was chosen according to the surgeon’s policy. A prospective randomized trial to compare the influence of hospitalization with additional criteria should be performed. Preoperative and postoperative anxiety, number of preoperative and postoperative medical visits, timing between initial visit and operative day, number of unscheduled visits before surgery, number of cancelled procedures, and number of patients lost to follow-up after surgery would have to be assessed. Any additional prospective study must include a broad population and focus on the impact of the type of hospitalization to confirm and complete the findings of the present study. In conclusion, the present secondary analysis of a previous prospective trial has shown that the type of hospitalization has no influence on the outcome. Ambulatory management—which is likely to become the gold standard in the future—does not appear to be associated with any degradation in the long-term outcome of surgical procedures for SUI. Conflict of interest The authors have no conflicts of interest. References [1] Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, et al. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol 2010;151(1):14–9. [2] Erekson EA, Lopes VV, Raker CA, Sung VW. Ambulatory procedures for female pelvic floor disorders in the United States. Am J Obstet Gynecol 2010;203(5):497.e1–5.
T. Thubert et al. / International Journal of Gynecology and Obstetrics 129 (2015) 123–127 [3] Suskind AM, Kaufman SR, Dunn RL, Stoffel JT, Clemens JQ, Hollenbeck BK. Populationbased trends in ambulatory surgery for urinary incontinence. Int Urogynecol J 2013; 24(2):207–11. [4] Abdel-Fattah M, Ramsay I. Transobturator tension free vaginal tapes: are they the way forward in the surgical treatment of urodynamic stress incontinence? Int J Surg 2007;5(1):3–10. [5] Khandwala S, Jayachandran C. TVT-Secur in office sling procedure under local anesthesia: a prospective 2-year analysis. Female Pelvic Med Reconstr Surg 2012;18(4):233–8. [6] Barron KI, Savageau JA, Young SB, Labin LC, Morse AN. Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(6):570–5. [7] Sivanesan K, Fattah MA, Ramsay I. Transobturator tape as a day surgery procedure: a case control study. Int J Surg 2007;5(3):152–4. [8] Deffieux X, Daher N, Mansoor A, Debodinance P, Muhlstein J, Fernandez H. Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up. Int Urogynecol J 2010;21(11):1337–45. [9] Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Subcommittee of the International Continence Society. Neurourol Urodyn 2002;21(2): 167–78.
127
[10] Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European psychometric validation of the CONTILIFE: a Quality of Life questionnaire for urinary incontinence. Eur Urol 2003;43(4):391–404. [11] De Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44(6): 724–30. [12] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7(2):81–5. [13] Rogo-Gupta L, Litwin MS, Saigal CS, Anger JT. Urologic Diseases in America Project. Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002–2007. Urology 2013;82(1):38–41. [14] van der Vaart CH, Lamers BH, Heintz AP. Feasibility and patient satisfaction with pelvic organ prolapse and urinary incontinence day surgery. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(5):531–6. [15] Hong B, Park S, Kim HS, Choo MS. Factors predictive of urinary retention after a tension-free vaginal tape procedure for female stress urinary incontinence. J Urol 2003;170(3):852–6. [16] Wang KH, Wang KH, Neimark M, Davila GW. Voiding dysfunction following TVT procedure. Int Urogynecol J Pelvic Floor Dysfunct 2002;13(6):353–7.