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Retrospective study on de novo postoperative urinary incontinence after pelvic organ prolapse surgery
European Journal of Obstetrics & Gynecology and Reproductive Biology 219 (2017) 10–14
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Full length article
Retrospective study on de novo postoperative urinary incontinence after pelvic organ prolapse surgery Aiste Ugianskiene* , Niels Kjærgaard, Anna Sofie Inger Lindquist, Thomas Larsen, Karin Glavind Department of Obstetrics and Gynecology, Aalborg University Hospital (AAUH), Denmark
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 August 2017 Received in revised form 27 September 2017 Accepted 2 October 2017 Available online xxx
Objective: Reported incidences of de novo urinary incontinence (UI) following pelvic organ prolapse (POP) surgery in preoperatively continent women vary between 2% and 43%. The aim of this study was to investigate the incidence and the types of de novo UI and differences between operations in different compartments. Study design: Retrospective study of 678 women with POP surgery using native tissue repair during a 3year period. Patients completed three modified prolapse questions from the International Consultation on Incontinence-Vaginal Symptoms (ICIQ-VS) and the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) before undergoing surgery and 3 months postoperatively. Patients who were totally dry and scored 0 on ICIQ-UI SF before surgery were included in the study (N = 299). The patients developing new onset UI on ICIQ-UI SF postoperatively were interviewed by telephone after median 30 months. Results: A total of 33 patients (11%) developed subjective de novo UI at 3 months follow-up. The majority of patients (N = 16) reported stress UI. The risk of developing de novo UI increased with parity (p = 0.03). We found no difference between operations in different compartments. At long-term follow-up 12 patients became continent without incontinence surgery or medical treatment leaving only 21 patients (7%) incontinent. Conclusion: The risk of developing de novo UI after prolapse surgery with native tissue repair is low and improves over time. Parity is significantly associated with the risk of developing de novo UI. There is no difference in the incidence of de novo incontinence between operations in different compartments. © 2017 Elsevier B.V. All rights reserved.
Keywords: De novo urinary incontinence Occult urinary incontinence Pelvic organ prolapse Stress urinary incontinence Urge urinary incontinence
Introduction Pelvic organ prolapse (POP) and urinary incontinence (UI) are two common diseases in women. Eleven to 19 percent of women will undergo surgery for POP or incontinence by age 80 to 85 years [1,2]. Both conditions share risk factors such as obesity, age and mainly pelvic floor damage as a consequence of birth. POP or UI or both conditions can be present in a patient. The relationship is complex and many factors are still unknown [3].
Abbreviation: UI, Urinary incontinence; SUI, stress urinary incontinence; POP, pelvic organ prolapse; ICIQ-VS, International Consultation on Incontinence-Vaginal Symptoms; ICIQ-UI SF, International Consultation on Incontinence QuestionnaireUrinary Incontinence Short Form. * Corresponding author at: Department of Obstetrics and Gynecology, Aalborg University Hospital, Reberbansgade 15, 9000 Aalborg, Denmark. E-mail address: [email protected] (A. Ugianskiene). https://doi.org/10.1016/j.ejogrb.2017.10.002 0301-2115/© 2017 Elsevier B.V. All rights reserved.
In some cases, women who are preoperatively continent experience de novo incontinence also named occult UI or “masked incontinence” after prolapse surgery. The theory behind de novo incontinence in patients with prolapse is that the prolapse creates a mechanical kinking of the urethra or a cushion effect under the urethra [4–8]. This effect supposedly disappears when the patient is operated and the incontinence is demasked. Apart from the “demasked theory”, other reasons for developing of urinary stress incontinence after prolapse surgery are not fully understood. Periurethral fibrosis, scarring and partial urethral denervation are direct consequences of anterior vaginal surgery under the urethra and the urethrovesical junction. The neuropathic effect created by the dissection under the urethra might play a role in the development of postoperative stress incontinence after prolapse surgery [9]. International Urogynecological Association (IUGA)/International Continence Society (ICS) define occult SUI as “SUI only observed after reduction of co-existent prolapse” [10]. This can be diagnosed
A. Ugianskiene et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 219 (2017) 10–14
preoperatively using various techniques to reduce the prolapse or postoperatively after POP repair. There is no standard definition concerning the time-span between operation and de novo UI. However, in this study, we defined it as the development of UI 3 months after POP surgery. The incidence of de novo incontinence is unknown and the reported incidences vary between 2% and 43% [7,9,11–22]. The wide range of surgical techniques including modifications and submodifications together with very different ways of indicating prolapse surgery might be a reason for this difference. Most studies report only the incidence of de novo stress UI (SUI), missing data about de novo urge UI (UUI) [9,11–14,16–22]. The main purpose of this study was to investigate the incidence and the type of de novo incontinence after prolapse surgery and to investigate if any difference was found in relation to operations in different compartments. Secondarily we investigated the association between de novo incontinence and the patient reported outcome of the prolapse operation. Material and methods All medical case records and data from the national Danish Urogynecological Database [23] were reviewed for all patients who underwent a prolapse procedure in our department during a 3year period between January 2012 and January 2015. A total of 678 patients were identified (Fig. 1). The indication for an operation was a symptomatic genital prolapse and Pelvic Organ Prolapse Quantification (POPQ) grade 2 or more. All patients completed three modified prolapse questions from the International Consultation on Incontinence-Vaginal Symptoms (ICIQ-VS) [24] and the International Consultation on Incontinence – Urinary Incontinence Short Form (ICIQ-UI SF) [25,26] before surgery and 3 months postoperatively. The three modified questions from ICIQ-VS used in our evaluation of symptomatic bulge sensation were: 1: “Do you feel a lump or bulge come out of your vagina or can you feel a lump in or outside of your vagina? ” (ever (0), occasionally (1), sometimes (2), most of the time (3) or all of the time (4)) and 2: “How much does this bother you?” not at all (0), a little (1), some (2), very much (3) and 3: “How much does this affect your daily life?” (0–10). A score was constructed with 0 in an asymptomatic patient and a score of 17 in a patient with maximum bother. ICIQ-UI-SF was used to evaluate the severity of urinary incontinence and its impact on health-related quality of life. The short form contains three scored items and an un-scored selfdiagnostic item. A total score for the three scored items is calculated by adding them up. A score of 0 indicates a totally continent patient. Maximum score for worst incontinence is 21. The un-scored self-diagnostic item is used to classify the type of incontinence: stress, urge, mixed or undefined incontinence. Undefined UI is described as “leaks when you have finished urinating and are dressed” and “leaks for no obvious reasons”. The Danish version of the ICIQ-UI SF has been translated from English but has not been validated. De novo incontinence was defined as an ICIQ-UI-SF > 0 three months postoperatively. Patients without urinary incontinence defined as a score of 0 on ICIQ-UI SF before surgery were included in the study population which consisted of 299 continent women. Demographic data included age, body mass index (BMI), number of births, previous caesarean sections and previous prolapse and incontinence operations. Preoperative evaluation included medical history and physical examination including POPQ. We chose to group all patients in three groups. Group A included all patients with an operation in the anterior
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compartment with and without surgery in other compartments (colporrhaphy anterior alone or with cervix amputation/vaginal hysterectomy/colporrhaphy posterior/enterocele operation). Group B included all patients with an operation in the middle compartment and no operation in the anterior compartment (cervix amputation/vaginal hysterectomy/vaginal vault suspension alone or with colporrhaphy posterior, enterocele operation). Group C included all patients with an operation only in the posterior compartment (colporrhaphy posterior, enterocele operation). All patients were operated in our outpatient clinic using native tissue repair and site-specific repair when indicated. Recurrent cases (N = 38) were in some instances reinforced with a biological mesh (N = 7) (surgicis). No synthetic meshes were used. No concomitant incontinence procedures were performed. If a patient was not ready to go home in the evening, she was admitted until the next day. Postoperative clinical follow-up was performed for all patients except patients who underwent simple uncomplicated colporrhaphy anterior surgery in which case a telephone interview was performed. No urine analysis was performed neither at three months nor at long-term follow-up. In June 2016, all patients with de novo incontinence at the 3 months follow-up were interviewed by telephone in order to
Fig. 1. Flow diagram of inclusion and follow-up.
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collect data for a long-term follow up. The same questionnaires were used. The primary outcome measure was the number of patients developing new onset urinary incontinence (stress, urge, mixed or undefined) on ICIQ-UI SF 3 months postoperatively and status at long-term follow-up. Secondarily we investigated in de novo UI according to operations in different compartments. Statistical analysis: Descriptive statistics were calculated to describe the study population, using Excel (Microsoft office 2013). The incidence of the primary outcome de novo UI was calculated as the number of patients with endpoint of de novo UI over the total number in the study group. Categorical data were analyzed using Chi-square test or Fishers exact test if there were 5 subjects in one of the cells. Continuous data not normally distributed were analyzed using a Mann-Whitney, non-paired, rank test with SPSS (version 24). Confounding variables were compared between patients with de novo UI and those without using parametric or non-parametric statistics as appropriate. The Ethics Committee, Region Nordjylland, Denmark approved the study. The study was registered at The Health Department, Region Nordjylland (no.2016-225). Results Demographic data of the study population are shown in Table 1. The risk of developing de novo UI increased with parity (p = 0.03). There was no statistical difference between patients with de novo UI and patients without UI after prolapse surgery concerning age, BMI or previous surgery (Table 1). Of the 299 patients with no complaints of any urinary incontinence before surgery, 33 patients (11%) developed subjective de novo UI at 3 months follow-up. A total of 16 patients (48.5%) reported stress UI, 12 patients (36.4%) urgency UI, 3 patients (9.1%) mixed UI and 2 patients (6.1%) undefined UI (Fig. 1). De novo stress UI (mixed and pure) at 3 months follow-up was thus reported in 6% (19 out of 299) of all patients. Median long-term follow-up was 30 months (range 18–44). No patients were lost to long-term follow-up. At long-term follow-up 12 patients out of 33 patients with de novo UI had become continent and a total of 21 patients (7%) remained incontinent. Only one patient had been treated with anticholinergic medicine because of urgency UI for a short period and no incontinence procedures or prolapse procedures had been performed. A total of 9 patients (42.9%) reported stress UI, 6 patients (28.6%) urgency UI, 4 patients (19%) mixed UI and 2 patients (9.5%) undefined UI (Fig. 1). At long- term follow-up, de novo stress UI (mixed and pure) thus decreased to 4% (13 out of 299 patients). Mean ICIQ-UI SF score at 3 months follow-up among the 33 patients with incontinence was 6.27. At the long-term follow-up, still incontinent 21 patients had a mean ICIQ-UI SF score of 5.25.
Among the 12 patients who became continent at the long-term follow-up, 5 patients had SUI, 6 patients UUI and one patient mixed UI at 3 months follow-up. Seven out of 12 patients (58.3%) used local hormonal treatment. The groups of surgery and incidence of de novo incontinence are shown in Fig. 2. There was no significant difference in incidence of de novo incontinence between operations in different compartments. Pre- and postoperative data on the ICIQ VS score showed statistically significant improvement in all 33 patients, with preoperative mean score of 12 declining to 0.78 at 3 months follow-up. At the long-term follow-up, the mean prolapse score was slightly higher with a mean score of 2.78. Considering the 12 patients, who became continent at the long-term follow-up, 4 patients had an increase in prolapse score, the rest an ICIQ VS score of 0. All four patients with positive ICIQ-VS scores stated UUI at 3 months follow-up and not SUI. Discussion In this study, we found that the incidence of subjective de novo UI at 3 months follow-up was 11% declining at long-term follow-up to 7%. It is somewhat difficult to compare our data to other studies because most of the studies investigated only the incidence of de novo stress UI postoperatively. The incidence of de novo stress UI at 3 months follow-up in our study was 6% declining to 4% at longterm follow-up. The numbers are low compared to the results from other studies [7,9,12–14,16–21]. To the best of our knowledge, only Kleeman et al. [11] reported lower incidence of de novo stress UI (1.9%) than we found in our study. However, these authors excluded patients with occult SUI from the study. Although different techniques to reduce the prolapse have been described, a gold standard has not been established. Neither the speculum nor the pessary test to reduce the prolapse had acceptable positive predictive values to identify women with occult UI [27]. Which is why we did not investigate for occult SUI in our clinic. In a study by Borstad et al. [13] 22% of 73 preoperatively continent patients became stress incontinent after a Manchester procedure 3 months postoperatively. Advanced age increased the risk but no urodynamic factors proved predictive. A few other studies have also shown that older age is a risk factor for de novo UI [9,13,22], but we could not confirm this finding. Hafidh et al. [21] found an incidence of subjective SUI in 13.5% and objective SUI in 2% of 64 patients operated for POP. They only included patients who were continent by clinical assessment (history and physical examination) and in urodynamic studies with a reduced prolapse. It was suggested that large-scale studies are necessary to evaluate their findings. Our study of 299 patients contributes significantly to this aim. Kasturi et al. [18] investigated 63 patients who underwent total vaginal mesh (TVM) procedures without midurethral sling after a negative preoperative prolapse reduction stress test during an
Table 1 Demographics of the study population, patients with no incontinence and patients with de novo incontinence.
Age, median (range), years Parity, median Body mass index, kg/m2: mean (range) Cesarean section: n (%) Previous hysterectomy: n (%) Previous prolapse surgery: n (%) Previous anti-incontinence repair: n (%) a b c
Mann-Whitney test. Fishers exact test. Chi- square test.
Study population N = 299
No incontinence N = 266
De novo incontinence N = 33
P value
54 (22–80) 2 (0–7) 25,9 (17,26–40,5) 16 (5,3%) 51 (17%) 80 (26,7%) 8 (2,6%)
56 (22–80) 2 (0–7) 25,7 (17,26–40,5) 12 (4,5%) 44 (16,5%) 71 (26,7%) 8 (3%)
57 (28–68) 3 (1–5) 27,1 (21,9–37) 4 (12%) 7 (21,2%) 9 (27%) 0
0,48a 0,03a 0,073a 0,086b 0,12c 0,02c 0,60b
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Fig. 2. The groups of surgery and incidence of de novo incontinence at 3 months and long-term follow-up.
urodynamic session. They found that 25% of patients became stress incontinent. The authors could not rule out the possibility that a mesh shrinkage might affect anterior wall support and perhaps cause “overcorrection” which would perhaps lead to de novo SUI. A very high occurrence of de novo SUI (71% 5/7) after mesh interventions was described by Ennemoser et al. [16] compared to 12.3% (7/57) in the group without mesh. Although the number of patients is small, the authors suggest that this finding could be explained by better reconstruction effect due to mesh intervention in comparison to colporrhaphy with native tissue only. Lo et al. [9] also stated that two types of TVM (Total Prolift and Elevate Anterior/Apical) were significant predictors for postoperative de novo SUI. They found de novo SUI in 11% and the risk 3.5 times higher in women who had TVM procedures performed. They believed that the possible reason for de novo SUI with both types of TVM was due to the extensive dissection of the paravesical space, which contributes to tissue damage and denervation. No synthetic meshes were used in our study that might explain our low incidence of de novo SUI. In contrast to some previous studies [9,13,14,22], parity was found to be a risk factor for developing de novo UI in our study. We believe that it is associated with pelvic floor damage during the labor. Kasturi et al. [18] found a trend toward higher gravidity in the group that developed novo stress UI. At long-term follow-up, 12 patients out of 33 with de novo incontinence became continent in our study. One possible explanation could be use of local hormone treatment in 58.3% of patients or a recurrence of POP which could protect for SUI. All patients however who became continent at long-term follow-up and stated stress or mixed UI at 3 months follow-up had ICIQ-VS score of 0 at long-term follow-up indicating no prolapse recurrence. A positive ICIQ-VS score was observed in four patients who had UUI at 3 months follow-up. The strength of our study is that the same questionnaire was used both pre- and postoperatively giving a more exact incidence of de novo UI and that no patients were lost to follow-up.
A limitation of this study is that no patients were tested postoperatively for UI with objective tests, nor urodynamic, but patients who scored 0 on ISIQ-UI SF were considered continent. Another weakness of the study is the follow-up by phone. The evidence from this study suggests that in continent women who are undergoing POP surgery, the risk of de novo SUI is low and therefore any prophylactic additional anti-incontinence procedure together with prolapse repair should not be performed. In conclusion, the risk of developing de novo urinary incontinence after prolapse surgery with native tissue repair is low (11%) and improves over time. Parity was significantly associated with risk of developing de novo UI. We found no difference in de novo incontinence in the different groups of operations.
Funding This study had no funding source. References [1] Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89(April (4)):501–6. [2] Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol 2003;188(January (1)):108–15. [3] Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am 1998;25(December (4)):723–46. [4] Long CY, Hsu SC, Wu TP, Sun DJ, Su JH, Tsai EM. Urodynamic comparison of continent and incontinent women with severe uterovaginal prolapse. J Reprod Med 2004;49(1):33–7. [5] Richardson D, Bent A, Ostergard D. The effect of uterovaginal prolapse on urethrovesical pressure dynamics. Am J Obstet Gynecol 1983;146(August (8)):901–5. [6] Bump RC, Fantl JA, Hurt WG. The mechanism of urinary continence in women with severe uterovaginal prolapse: results of barrier studies. Obstet Gynecol 1988;72(September (3 Pt 1)):291–5. [7] Lensen EJ, Withagen MI, Kluivers KB, Milani AL, Vierhout ME. Urinary incontinence after surgery for pelvic organ prolapse. Neurourol Urodyn 2013;32(June (5)):455–9.
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[8] Myers DL, Lasala CA, Hogan JW, Rosenblatt PL. The effect of posterior wall support defects on urodynamic indices in stress urinary incontinence. Obstet Gynecol 1998;91(May (5 Pt 1)):710–4. [9] Lo TS, Bt Karim N, Nawawi EA, Wu PY, Nusee Z. Predictors for de novo stress urinary incontinence following extensive pelvic reconstructive surgery. Int Urogynecol J 2015;26(September (9)):1313–9. [10] Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010;29(1):4–20. [11] Kleeman S, Vassallo B, Segal J, Hungler M, Karram M. The ability of history and a negative cough stress test to detect occult stress incontinence in patients undergoing surgical repair of advanced pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2006;1(January (1)):27–9. [12] Ellström Engh AM, Ekeryd A, Magnusson A, Olsson I, Otterlind L, Tobiasson G. Can de novo stress incontinence after anterior wall repair be predicted? Acta Obstet Gynecol Scand 2011;90(May (5)):488–93. [13] Borstad E, Rud T. The risk of developing urinary stress-incontinence after vaginal repair in continent women: a clinical and urodynamic follow-up study. Acta Obstet Gynecol Scand 1989;68(6):545–9. [14] Al-Mandeel H, Ross S, Robert M, Milne J. Incidence of stress urinary incontinence following vaginal repair of pelvic organ prolapse in objectively continent women. Neurourol Urodyn 2011 Mar;30(March (3)):390–4. [15] Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, et al. Pelvic floor disorders network: a midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med 2012;366(June (25)):2358–67. [16] Ennemoser S, Schönfeld M, von Bodungen V, Dian D, Friese K, Jundt K. Clinical relevance of occult stress urinary incontinence (OSUI) following vaginal prolapse surgery: long-term follow-up. Int Urogynecol J 2012;23(July (7)):851–5. [17] Jundt K, Wagner S, von Bodungen V, Friese K. Peschers UM. Occult incontinence in women with pelvic organ prolapse – Does it matter? Eur J Med Res 2010;15(March (3)):112–6.
[18] Kasturi S, Diaz SI, McDermott CD, Woodman PJ, Bump RC, Terry CL, et al. De novo stress urinary incontinence after negative prolapse reduction stress testing for total vaginal mesh procedures: incidence and risk factors. Am J Obstet Gynecol 2011205(November (5)) 487. e1-4. [19] El Hamamsy D, Fayyad AM. New onset stress urinary incontinence following laparoscopic sacrocolpopexy and its relation to anatomical outcomes. Int Urogynecol J 2015 Jul;26(7):1041–5. [20] LeClaire EL, Mukati MS, Juarez D, White D, Quiroz LH. Is de novo stress incontinence after sacrocolpopexy related to anatomical changes and surgical approach? Int Urogynecol J 2014;25(September (9)):1201–6. [21] Hafidh BA, Chou Q, Khalil MM, Al-Mandeel H. De novo stress urinary incontinence after vaginal repair for pelvic organ prolapse: one-year followup. Eur J Obstet Gynecol Reprod Biol 2013;168(June (2)):227–30. [22] Alas AN, Chinthakanan O, Espaillat L, Plowright L, Davila GW, Aguilar VC. De novo stress urinary incontinence after pelvic organ prolapse surgery in women without occult incontinence. Int Urogynecol J 2017;28(April (4)):583–90. [23] Guldberg R, Brostrøm S, Hansen JK, Kærlev L, Gradel KO, Nørgård BM, et al. The Danish urogynecological database: establishment, completeness and validity. Int Urogynecol J 2013;24(June (6)):983–90. [24] Price N, Jackson SR, Avery K, Brookes ST, Abrams P. Development and psychometric evaluation of the ICIQ vaginal symptoms questionnaire: the ICIQ-VS. BJOG 2006;113(6):700–12. [25] Abrams P, Avery K, Gardener N, Donovan J. ICIQ advisory board. The international consultation on incontinence modular questionnaire: www. iciq.net. J Urol 2006;175(March (3 Pt 1)):1063–6. [26] Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23(4):322–30. [27] King AB, Goldman HB. Stress incontinence surgery at the time of prolapse surgery: mandatory or forbidden? World J Urol 2015;33(September (9)):1257– 62.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Full length article
Retrospective study on de novo postoperative urinary incontinence after pelvic organ prolapse surgery Aiste Ugianskiene* , Niels Kjærgaard, Anna Sofie Inger Lindquist, Thomas Larsen, Karin Glavind Department of Obstetrics and Gynecology, Aalborg University Hospital (AAUH), Denmark
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 August 2017 Received in revised form 27 September 2017 Accepted 2 October 2017 Available online xxx
Objective: Reported incidences of de novo urinary incontinence (UI) following pelvic organ prolapse (POP) surgery in preoperatively continent women vary between 2% and 43%. The aim of this study was to investigate the incidence and the types of de novo UI and differences between operations in different compartments. Study design: Retrospective study of 678 women with POP surgery using native tissue repair during a 3year period. Patients completed three modified prolapse questions from the International Consultation on Incontinence-Vaginal Symptoms (ICIQ-VS) and the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) before undergoing surgery and 3 months postoperatively. Patients who were totally dry and scored 0 on ICIQ-UI SF before surgery were included in the study (N = 299). The patients developing new onset UI on ICIQ-UI SF postoperatively were interviewed by telephone after median 30 months. Results: A total of 33 patients (11%) developed subjective de novo UI at 3 months follow-up. The majority of patients (N = 16) reported stress UI. The risk of developing de novo UI increased with parity (p = 0.03). We found no difference between operations in different compartments. At long-term follow-up 12 patients became continent without incontinence surgery or medical treatment leaving only 21 patients (7%) incontinent. Conclusion: The risk of developing de novo UI after prolapse surgery with native tissue repair is low and improves over time. Parity is significantly associated with the risk of developing de novo UI. There is no difference in the incidence of de novo incontinence between operations in different compartments. © 2017 Elsevier B.V. All rights reserved.
Keywords: De novo urinary incontinence Occult urinary incontinence Pelvic organ prolapse Stress urinary incontinence Urge urinary incontinence
Introduction Pelvic organ prolapse (POP) and urinary incontinence (UI) are two common diseases in women. Eleven to 19 percent of women will undergo surgery for POP or incontinence by age 80 to 85 years [1,2]. Both conditions share risk factors such as obesity, age and mainly pelvic floor damage as a consequence of birth. POP or UI or both conditions can be present in a patient. The relationship is complex and many factors are still unknown [3].
Abbreviation: UI, Urinary incontinence; SUI, stress urinary incontinence; POP, pelvic organ prolapse; ICIQ-VS, International Consultation on Incontinence-Vaginal Symptoms; ICIQ-UI SF, International Consultation on Incontinence QuestionnaireUrinary Incontinence Short Form. * Corresponding author at: Department of Obstetrics and Gynecology, Aalborg University Hospital, Reberbansgade 15, 9000 Aalborg, Denmark. E-mail address: [email protected] (A. Ugianskiene). https://doi.org/10.1016/j.ejogrb.2017.10.002 0301-2115/© 2017 Elsevier B.V. All rights reserved.
In some cases, women who are preoperatively continent experience de novo incontinence also named occult UI or “masked incontinence” after prolapse surgery. The theory behind de novo incontinence in patients with prolapse is that the prolapse creates a mechanical kinking of the urethra or a cushion effect under the urethra [4–8]. This effect supposedly disappears when the patient is operated and the incontinence is demasked. Apart from the “demasked theory”, other reasons for developing of urinary stress incontinence after prolapse surgery are not fully understood. Periurethral fibrosis, scarring and partial urethral denervation are direct consequences of anterior vaginal surgery under the urethra and the urethrovesical junction. The neuropathic effect created by the dissection under the urethra might play a role in the development of postoperative stress incontinence after prolapse surgery [9]. International Urogynecological Association (IUGA)/International Continence Society (ICS) define occult SUI as “SUI only observed after reduction of co-existent prolapse” [10]. This can be diagnosed
A. Ugianskiene et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 219 (2017) 10–14
preoperatively using various techniques to reduce the prolapse or postoperatively after POP repair. There is no standard definition concerning the time-span between operation and de novo UI. However, in this study, we defined it as the development of UI 3 months after POP surgery. The incidence of de novo incontinence is unknown and the reported incidences vary between 2% and 43% [7,9,11–22]. The wide range of surgical techniques including modifications and submodifications together with very different ways of indicating prolapse surgery might be a reason for this difference. Most studies report only the incidence of de novo stress UI (SUI), missing data about de novo urge UI (UUI) [9,11–14,16–22]. The main purpose of this study was to investigate the incidence and the type of de novo incontinence after prolapse surgery and to investigate if any difference was found in relation to operations in different compartments. Secondarily we investigated the association between de novo incontinence and the patient reported outcome of the prolapse operation. Material and methods All medical case records and data from the national Danish Urogynecological Database [23] were reviewed for all patients who underwent a prolapse procedure in our department during a 3year period between January 2012 and January 2015. A total of 678 patients were identified (Fig. 1). The indication for an operation was a symptomatic genital prolapse and Pelvic Organ Prolapse Quantification (POPQ) grade 2 or more. All patients completed three modified prolapse questions from the International Consultation on Incontinence-Vaginal Symptoms (ICIQ-VS) [24] and the International Consultation on Incontinence – Urinary Incontinence Short Form (ICIQ-UI SF) [25,26] before surgery and 3 months postoperatively. The three modified questions from ICIQ-VS used in our evaluation of symptomatic bulge sensation were: 1: “Do you feel a lump or bulge come out of your vagina or can you feel a lump in or outside of your vagina? ” (ever (0), occasionally (1), sometimes (2), most of the time (3) or all of the time (4)) and 2: “How much does this bother you?” not at all (0), a little (1), some (2), very much (3) and 3: “How much does this affect your daily life?” (0–10). A score was constructed with 0 in an asymptomatic patient and a score of 17 in a patient with maximum bother. ICIQ-UI-SF was used to evaluate the severity of urinary incontinence and its impact on health-related quality of life. The short form contains three scored items and an un-scored selfdiagnostic item. A total score for the three scored items is calculated by adding them up. A score of 0 indicates a totally continent patient. Maximum score for worst incontinence is 21. The un-scored self-diagnostic item is used to classify the type of incontinence: stress, urge, mixed or undefined incontinence. Undefined UI is described as “leaks when you have finished urinating and are dressed” and “leaks for no obvious reasons”. The Danish version of the ICIQ-UI SF has been translated from English but has not been validated. De novo incontinence was defined as an ICIQ-UI-SF > 0 three months postoperatively. Patients without urinary incontinence defined as a score of 0 on ICIQ-UI SF before surgery were included in the study population which consisted of 299 continent women. Demographic data included age, body mass index (BMI), number of births, previous caesarean sections and previous prolapse and incontinence operations. Preoperative evaluation included medical history and physical examination including POPQ. We chose to group all patients in three groups. Group A included all patients with an operation in the anterior
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compartment with and without surgery in other compartments (colporrhaphy anterior alone or with cervix amputation/vaginal hysterectomy/colporrhaphy posterior/enterocele operation). Group B included all patients with an operation in the middle compartment and no operation in the anterior compartment (cervix amputation/vaginal hysterectomy/vaginal vault suspension alone or with colporrhaphy posterior, enterocele operation). Group C included all patients with an operation only in the posterior compartment (colporrhaphy posterior, enterocele operation). All patients were operated in our outpatient clinic using native tissue repair and site-specific repair when indicated. Recurrent cases (N = 38) were in some instances reinforced with a biological mesh (N = 7) (surgicis). No synthetic meshes were used. No concomitant incontinence procedures were performed. If a patient was not ready to go home in the evening, she was admitted until the next day. Postoperative clinical follow-up was performed for all patients except patients who underwent simple uncomplicated colporrhaphy anterior surgery in which case a telephone interview was performed. No urine analysis was performed neither at three months nor at long-term follow-up. In June 2016, all patients with de novo incontinence at the 3 months follow-up were interviewed by telephone in order to
Fig. 1. Flow diagram of inclusion and follow-up.
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collect data for a long-term follow up. The same questionnaires were used. The primary outcome measure was the number of patients developing new onset urinary incontinence (stress, urge, mixed or undefined) on ICIQ-UI SF 3 months postoperatively and status at long-term follow-up. Secondarily we investigated in de novo UI according to operations in different compartments. Statistical analysis: Descriptive statistics were calculated to describe the study population, using Excel (Microsoft office 2013). The incidence of the primary outcome de novo UI was calculated as the number of patients with endpoint of de novo UI over the total number in the study group. Categorical data were analyzed using Chi-square test or Fishers exact test if there were 5 subjects in one of the cells. Continuous data not normally distributed were analyzed using a Mann-Whitney, non-paired, rank test with SPSS (version 24). Confounding variables were compared between patients with de novo UI and those without using parametric or non-parametric statistics as appropriate. The Ethics Committee, Region Nordjylland, Denmark approved the study. The study was registered at The Health Department, Region Nordjylland (no.2016-225). Results Demographic data of the study population are shown in Table 1. The risk of developing de novo UI increased with parity (p = 0.03). There was no statistical difference between patients with de novo UI and patients without UI after prolapse surgery concerning age, BMI or previous surgery (Table 1). Of the 299 patients with no complaints of any urinary incontinence before surgery, 33 patients (11%) developed subjective de novo UI at 3 months follow-up. A total of 16 patients (48.5%) reported stress UI, 12 patients (36.4%) urgency UI, 3 patients (9.1%) mixed UI and 2 patients (6.1%) undefined UI (Fig. 1). De novo stress UI (mixed and pure) at 3 months follow-up was thus reported in 6% (19 out of 299) of all patients. Median long-term follow-up was 30 months (range 18–44). No patients were lost to long-term follow-up. At long-term follow-up 12 patients out of 33 patients with de novo UI had become continent and a total of 21 patients (7%) remained incontinent. Only one patient had been treated with anticholinergic medicine because of urgency UI for a short period and no incontinence procedures or prolapse procedures had been performed. A total of 9 patients (42.9%) reported stress UI, 6 patients (28.6%) urgency UI, 4 patients (19%) mixed UI and 2 patients (9.5%) undefined UI (Fig. 1). At long- term follow-up, de novo stress UI (mixed and pure) thus decreased to 4% (13 out of 299 patients). Mean ICIQ-UI SF score at 3 months follow-up among the 33 patients with incontinence was 6.27. At the long-term follow-up, still incontinent 21 patients had a mean ICIQ-UI SF score of 5.25.
Among the 12 patients who became continent at the long-term follow-up, 5 patients had SUI, 6 patients UUI and one patient mixed UI at 3 months follow-up. Seven out of 12 patients (58.3%) used local hormonal treatment. The groups of surgery and incidence of de novo incontinence are shown in Fig. 2. There was no significant difference in incidence of de novo incontinence between operations in different compartments. Pre- and postoperative data on the ICIQ VS score showed statistically significant improvement in all 33 patients, with preoperative mean score of 12 declining to 0.78 at 3 months follow-up. At the long-term follow-up, the mean prolapse score was slightly higher with a mean score of 2.78. Considering the 12 patients, who became continent at the long-term follow-up, 4 patients had an increase in prolapse score, the rest an ICIQ VS score of 0. All four patients with positive ICIQ-VS scores stated UUI at 3 months follow-up and not SUI. Discussion In this study, we found that the incidence of subjective de novo UI at 3 months follow-up was 11% declining at long-term follow-up to 7%. It is somewhat difficult to compare our data to other studies because most of the studies investigated only the incidence of de novo stress UI postoperatively. The incidence of de novo stress UI at 3 months follow-up in our study was 6% declining to 4% at longterm follow-up. The numbers are low compared to the results from other studies [7,9,12–14,16–21]. To the best of our knowledge, only Kleeman et al. [11] reported lower incidence of de novo stress UI (1.9%) than we found in our study. However, these authors excluded patients with occult SUI from the study. Although different techniques to reduce the prolapse have been described, a gold standard has not been established. Neither the speculum nor the pessary test to reduce the prolapse had acceptable positive predictive values to identify women with occult UI [27]. Which is why we did not investigate for occult SUI in our clinic. In a study by Borstad et al. [13] 22% of 73 preoperatively continent patients became stress incontinent after a Manchester procedure 3 months postoperatively. Advanced age increased the risk but no urodynamic factors proved predictive. A few other studies have also shown that older age is a risk factor for de novo UI [9,13,22], but we could not confirm this finding. Hafidh et al. [21] found an incidence of subjective SUI in 13.5% and objective SUI in 2% of 64 patients operated for POP. They only included patients who were continent by clinical assessment (history and physical examination) and in urodynamic studies with a reduced prolapse. It was suggested that large-scale studies are necessary to evaluate their findings. Our study of 299 patients contributes significantly to this aim. Kasturi et al. [18] investigated 63 patients who underwent total vaginal mesh (TVM) procedures without midurethral sling after a negative preoperative prolapse reduction stress test during an
Table 1 Demographics of the study population, patients with no incontinence and patients with de novo incontinence.
Age, median (range), years Parity, median Body mass index, kg/m2: mean (range) Cesarean section: n (%) Previous hysterectomy: n (%) Previous prolapse surgery: n (%) Previous anti-incontinence repair: n (%) a b c
Mann-Whitney test. Fishers exact test. Chi- square test.
Study population N = 299
No incontinence N = 266
De novo incontinence N = 33
P value
54 (22–80) 2 (0–7) 25,9 (17,26–40,5) 16 (5,3%) 51 (17%) 80 (26,7%) 8 (2,6%)
56 (22–80) 2 (0–7) 25,7 (17,26–40,5) 12 (4,5%) 44 (16,5%) 71 (26,7%) 8 (3%)
57 (28–68) 3 (1–5) 27,1 (21,9–37) 4 (12%) 7 (21,2%) 9 (27%) 0
0,48a 0,03a 0,073a 0,086b 0,12c 0,02c 0,60b
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Fig. 2. The groups of surgery and incidence of de novo incontinence at 3 months and long-term follow-up.
urodynamic session. They found that 25% of patients became stress incontinent. The authors could not rule out the possibility that a mesh shrinkage might affect anterior wall support and perhaps cause “overcorrection” which would perhaps lead to de novo SUI. A very high occurrence of de novo SUI (71% 5/7) after mesh interventions was described by Ennemoser et al. [16] compared to 12.3% (7/57) in the group without mesh. Although the number of patients is small, the authors suggest that this finding could be explained by better reconstruction effect due to mesh intervention in comparison to colporrhaphy with native tissue only. Lo et al. [9] also stated that two types of TVM (Total Prolift and Elevate Anterior/Apical) were significant predictors for postoperative de novo SUI. They found de novo SUI in 11% and the risk 3.5 times higher in women who had TVM procedures performed. They believed that the possible reason for de novo SUI with both types of TVM was due to the extensive dissection of the paravesical space, which contributes to tissue damage and denervation. No synthetic meshes were used in our study that might explain our low incidence of de novo SUI. In contrast to some previous studies [9,13,14,22], parity was found to be a risk factor for developing de novo UI in our study. We believe that it is associated with pelvic floor damage during the labor. Kasturi et al. [18] found a trend toward higher gravidity in the group that developed novo stress UI. At long-term follow-up, 12 patients out of 33 with de novo incontinence became continent in our study. One possible explanation could be use of local hormone treatment in 58.3% of patients or a recurrence of POP which could protect for SUI. All patients however who became continent at long-term follow-up and stated stress or mixed UI at 3 months follow-up had ICIQ-VS score of 0 at long-term follow-up indicating no prolapse recurrence. A positive ICIQ-VS score was observed in four patients who had UUI at 3 months follow-up. The strength of our study is that the same questionnaire was used both pre- and postoperatively giving a more exact incidence of de novo UI and that no patients were lost to follow-up.
A limitation of this study is that no patients were tested postoperatively for UI with objective tests, nor urodynamic, but patients who scored 0 on ISIQ-UI SF were considered continent. Another weakness of the study is the follow-up by phone. The evidence from this study suggests that in continent women who are undergoing POP surgery, the risk of de novo SUI is low and therefore any prophylactic additional anti-incontinence procedure together with prolapse repair should not be performed. In conclusion, the risk of developing de novo urinary incontinence after prolapse surgery with native tissue repair is low (11%) and improves over time. Parity was significantly associated with risk of developing de novo UI. We found no difference in de novo incontinence in the different groups of operations.
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