Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse? Results of a Pragmatic Approach

UROGYNAECOLOGY

Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse? Results of a Pragmatic Approach Natalia Ovtcharenko, MD, HBSc; Jessica Pudwell, MPH; Marie-Andrée Harvey, MD, MSc Department of Obstetrics and Gynaecology, Queen’s University, Kingston, ON

N. Ovtcharenko

Abstract Objective: Pelvic organ prolapse (POP) surgery may unmask occult stress urinary incontinence (OSUI) in otherwise asymptomatic patients. Preoperative urodynamic studies (UDSs) with prolapse reduction may, by potentially unmasking OSUI, assist surgical decision making. This study investigated the long-term objective postoperative rate of SUI, according to the presence of OSUI. Methods: This retrospective cohort study was conducted with a crosssectional survey of women with no SUI or rare SUI presenting at Kingston General Hospital in Kingston, Ontario from 2003-2013 for POP. Patients were compared on the basis of preoperative UDS results and whether an anti-incontinence procedure was performed in addition to POP surgery. The study included a chart review of 1-year follow-up subjective results and a survey of long-term objective results (symptoms and quality of life) ascertained by validated questionnaires. Results: The study enrolled 113 women, 51 of whom had undergone anti-incontinence surgery (42 for identified OSUI, nine prophylactically). In women whose UDS results indicated OSUI, 1-year subjective and long-term objective postoperative SUI results were, respectively, 8.8% and 12.5% among women undergoing POP and anti-incontinence surgery and 18.2% and 42.9% among those undergoing POP surgery alone. In women with negative UDS results, those rates were 0.0% and 50.0% and 12.8% and 27.6%, respectively. There was no significant difference in any outcomes, according to procedure choice in the OSUI-positive group. There were no predictors for postoperative SUI.
e Harvey, Department of Corresponding author: Dr. Marie-Andre Obstetrics and Gynaecology, Queen’s University Queen’s University, Kingston, ON. [email protected] Competing interests: The authors declare that they have no competing interests. The authors have indicated that they meet the journal’s requirements for authorship. Received on August 18, 2017 Accepted on October 3, 2017

Conclusion: Although a trend was seen for less long-term validated subjective SUI in women having a concomitant SUI procedure along with POP corrective surgery, no significant difference in outcomes was found, on the basis of procedure of choice, and no reliable predictors for postoperative SUI could be identified. UDS testing may be useful to rule in OSUI, but its clinical value in surgical decision making is uncertain.

Résumé Objectif : Le traitement chirurgical du prolapsus des organes pelviens
ve
ler une incontinence urinaire a  l’effort (IUE) (POP) pourrait re occulte chez des patientes autrement asymptomatiques. Les bilans
ope
ratoires combine
s a  la re
duction du urodynamiques pre
tection potentielle d’une IUE occulte, prolapsus pourraient, par la de  la prise de de
cisions chirurgicales. Cette e
tude s’est aider a
e sur le taux postope
ratoire objectif a  long terme de l’IUE, en penche
sence d’une IUE occulte. fonction de la pre
tude de cohorte re
trospective a e
te
re
alise
e au Méthodologie : L’e
tude transversale mene
e aupre s de femmes sans moyen d’une e
sente
es au Kingston IUE ou atteintes d’une rare IUE qui se sont pre  Kingston, en Ontario, entre 2003 et 2013 en General Hospital a
te
compare
es en fonction des raison d’un POP. Les patientes ont e
sultats du bilan urodynamique et de celles qui ont subi ou non une re intervention pour traiter l’incontinence en plus d’un traitement
tude comprenait l’analyse des dossiers chirurgical du POP. L’e
dicaux pour conna^ıtre les re
sultats subjectifs du suivi apre  s 1 an me
sultats objectifs a  long terme (sympto ^mes et et un examen des re
de vie) e
value
s au moyen de questionnaires valide
s. qualite
tude a porte
sur 113 femmes, dont 51 ont subi une Résultats : L’e intervention chirurgicale anti-incontinence (dont 42 pour une IUE
tecte
e et 9 pour un traitement prophylactique). Chez les occulte de
sultats des bilans urodynamiques ont re
ve
le
une femmes dont les re
sultats d’IUE postope
ratoires subjectifs apre s 1 IUE occulte, les re  long terme e
taient, respectivement, de 8,8 % et an et objectifs a 12,5 % chez les femmes qui ont subi un traitement chirurgical antiincontinence et du POP et de 18,2 % et 42,9 % chez celles qui ont uniquement subi un traitement chirurgical du POP. Chez les
sultat ne
gatif au bilan urodynamique, femmes qui ont obtenu un re  0,0 % et 50,0 % ainsi qu’a  les taux se chiffraient respectivement a

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12,8 % et 27,6 %. Dans le groupe de femmes atteintes d’une IUE
rence significative n’a e
te
releve
e dans les occulte, aucune diffe
dictif issues selon l’intervention choisie. Il n’y avait aucun facteur pre
ratoire. de l’IUE postope ^ me si l’on ait observe
une tendance de re
sultats Conclusion : Me
s d’IUE a  plus court terme chez les femmes ayant subjectifs valide subi un traitement chirurgical concomitant anti-incontinence et du
rence significative n’a e
te
constate
e dans les POP, aucune diffe
dictif fiable de issues selon le traitement choisi et aucun facteur pre
ratoire n’a pu e ^tre de
termine
. Les bilans l’IUE postope ^tre utiles pour confirmer une IUE urodynamiques pourraient e
clinique dans la prise de de
cisions occulte, mais son utilite chirurgicales est incertaine. © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

J Obstet Gynaecol Can 2019;000(000):1−10 https://doi.org/10.1016/j.jogc.2017.10.037

INTRODUCTION

elvic organ prolapse (POP) and stress urinary incontinence (SUI) are conditions that have a significant impact on quality of life. The estimated lifetime risk that a woman will have POP surgery ranges from 11.1% in the United States to 19% in Australia.1−3 When women present with POP, some may deny current SUI. For these women, SUI may be unmasked when POP is reduced, a situation referred to as occult SUI (OSUI). As a result, SUI may manifest de novo after POP surgery as the presumed urethral kinking has been relieved. The Colpopexy and Urinary Reduction Efforts (CARE) trial4 and the Outcomes following vaginal Prolapse repair and mid-Urethral Sling (OPUS) trial5 demonstrated rates of 44.1% and 49.4% of postoperative SUI, respectively, in patients undergoing POP surgery alone versus 23.8% and 23.6%, respectively, in patients who had an anti-incontinence procedure. Consequently, prophylactic anti-incontinence surgery now tends to be recommended to continent patients or those with no SUI or rare SUI at the time of POP surgery.

P

Testing for OSUI can be performed by reducing the POP preoperatively using various methods, such as with a pessary or speculum, and then testing for SUI with a cough stress test. Given this test’s potential value, an area of study has emerged assessing the degree to which it is predictive of postoperative SUI. It can then guide surgical decision making between POP surgery alone or POP surgery with a concomitant anti-incontinence procedure. Secondary outcomes of the OPUS and CARE trials assessed the value of OSUI testing.5,6 The OPUS trial showed some benefit to a mid-urethral sling procedure for patients with a positive

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OSUI test result: at 3 months postoperatively, postoperative SUI prevalence was 29.6% versus 71.9% (sling vs. control).5 In the CARE trial, at 3 months, postoperative SUI prevalence in OSUI-positive patients was 37% versus 60% (Burch vs control).6 Two smaller studies, in which all patients had positive test results for OSUI, found an incidence of about 28% for postoperative SUI with POP surgery alone.7,8 When anti-incontinence surgery was added in the study by Liapis et al., the rate of postoperative SUI was 9.3%.8 Although these studies have provided evidence favouring testing for OSUI as a predictor of postoperative outcomes, the data are inconclusive. The CARE and OPUS trials found some benefit to testing but did not make a definitive recommendation given the false-negative rate. Furthermore, both in meta-analysis and in individual studies, it has been recommended that the decision on concomitant antiincontinence surgery be made on a case-by-case basis with patients.9 Furthermore, multiple methods for the detection of OSUI were used across the many trials, thus making it difficult to assess testing for OSUI, compare the studies, and extrapolate to a given clinical situation. These trials also had short follow-up times (3 and 12 months) for their outcomes. These differences are highlighted in the comparisons made by Visco et al.6 This study sought to report the rate of SUI following POP surgery in a group of women with no SUI or rare SUI and to determine whether the UDS results were indicative of postoperative continence status in those women whose choice to undergo a concomitant continence surgery followed the UDS prediction of OSUI. Furthermore, a secondary analysis sought to compare the overall rate of postoperative SUI in the cohort of women who underwent surgical counselling before the publication of the CARE trial (i.e., mostly on the basis of on UDS determination of OSUI) with the postoperative SUI rate in women who were counselled using the evidence-based literature in addition to the UDS testing. The study was thus performed using a pragmatic approach, focusing on patients’ autonomous decision after counselling. METHODS

The patient population included all patients presenting to the urogynaecology team at Kingston General Hospital (KGH) in Kingston, Ontario, a mid-size, tertiary, university-affiliated academic centre, who underwent POP surgery between January 2003 and December 2013. Eligible patients were identified through chart review. Patients were included if their clinic note recorded “very rare” or

Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse?

“occasional” SUI on the standardized intake form on the first visit. Patients were excluded if they had “moderate” or “significant” preoperative SUI, had undergone an antiincontinence procedure alone, or had no record of a twostage UDS in their clinic chart. Patients whose surgical procedures were performed in or before 2006 (pre-CARE) were deemed to have been counselled mostly on the basis of their UDS results, with the general recommendation of adding continence surgery for those women with OSUI on noted UDS. Women who underwent surgery in 2007 or after were deemed to have been counselled using the UDS results with an explanation of the evidenced-based effect of continence surgery, as published in the CARE trial (post-CARE). Chart review was used to record the following information: demographic information; International Consultation on Incontinence Questionnaire − Short Form (ICIQ Short Form) results at the first clinic appointment, prior incontinence and POP surgical procedures, surgical procedures performed during the study period; and the presence or absence of SUI at 1-year follow-up (short-term selfreported subjective SUI), according to patients’ response to a routine question on the presence and type of incontinence postoperatively. Eligible patients were then sent three validated questionnaires to determine long-term validated subjective outcomes: the ICIQ Short Form questionnaire, the Urogenital Distress Inventory Short Form (UDI-6), and the Incontinence Impact Questionnaire Short Form (IIQ-7), as well as a checklist to determine whether any follow-up treatment for SUI was received. The UDI-6 contains six questions, each scored from 0 to 3, with 0 indicating that patients are not bothered at all by symptoms and 3 indicating that they are greatly bothered; the score is then converted to a score out of 100.10 The IIQ-7 is scored in a similar manner.10 The ICIQ Short Form has three questions about the frequency and the quantity of incontinence and degree of interference with everyday life, scored on a numeric severity scale. The scores from all questions are summed, and the total ranges from 0 to 21, with 0 indicating no incontinence.11 Two weeks were given for response time, following which the primary investigator followed up on missing results through telephone calls. As necessary, the questionnaires were either re-mailed or answered over the telephone. At the Kingston General Hospital urogynaecology clinic, preoperative “two-stage” UDS testing typically is used for diagnosis of OSUI for the purpose of surgical counselling

in patients with stage II or greater POP. The UDS is done once without a pessary and is immediately repeated with a pessary, either a ring or Gellhorn type, depending on the patient’s ability to retain a ring pessary. Women who were using a pessary at the time of the UDS started with the pessary in place; the pessary was removed for the second stage of the study. The presence of urodynamic stress incontinence on POP reduction with a pessary alone or incontinence both with and without a pessary is considered to be a positive result for the presence of OSUI in a woman who is otherwise asymptomatic. A positive result was defined as demonstrable incontinence at 300 mL or, if no leak was observed at 300 mL, at capacity when lying or standing, whichever became positive, during a Valsalva manoeuvre or cough. At the discretion of the care provider, video UDS may be used to confirm OSUI or to further assess a patient when there is doubt about a negative result in twostage UDS testing. During video UDS, reduction of POP is obtained with a Regula pessary (Cooper Surgical, Trumbull, CT) or by manual reduction under fluoroscopy; this ensures optimal bladder base support while confirming the absence of urethral obstruction from the reduction method used. OSUI on video UDS was also considered a positive result given that it would significantly affect surgical decision making. The primary outcome was long-term validated subjective SUI, on the basis of the UDI-6 questionnaire beyond the 1-year postoperative clinical follow-up visit. A response of ≥1 to question 3 was considered positive for SUI. Question 3 asks: “Do you experience, and if so, how much are you bothered by leakage related to physical activity, coughing, or sneezing?” Secondary outcomes included short-term subjective SUI at the 1-year follow-up clinic visit according to the patient’s self-reports of SUI, follow-up treatment for SUI, and the scores on each of the three questionnaires. This study obtained ethical clearance from the Health Sciences Research Ethics Board at Queen’s University in Kingston, Ontario (file #6015263). All terms are used in accordance to the International Continence Society.12 Statistical Analysis

Demographic variables and outcomes were compared using the chi-square test for categorical variables, the Mann-Whitney U test or Kruskal-Wallis test for non-normal data and the Student t test or analysis of variance for normally distributed data. The Fisher exact method was used when cell counts were <5 patients. Counts and frequencies are provided for categorical data; median and

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interquartile ranges are provided for non-normal data and mean and SD for normally distributed data. Significance was defined as a P value <0.05. Data were analyzed from two perspectives. First, patients were divided according to the presence or absence of OSUI preoperatively and subsequent outcomes on the basis of surgical choice. Short- and long-term outcomes for OSUI-positive and OSUI-negative patients were compared. These two groups were then divided according to whether patients received either POP surgery alone or POP surgery with a concomitant anti-incontinence procedure. Second, this analysis was reversed, and patients were first divided according to the surgical decision (POP or POP-SUI surgery) and then by OSUI status. A logistic regression analysis was conducted with the outcome of long-term validated subjective SUI as the dependent variable and OSUI status and concomitant SUI surgery as independent variables, regardless of significance. Other variables considered in the analysis included age (years), body mass index (kg/m2), pre-CARE trial versus post-CARE trial, prior SUI surgery (yes/no), and parity (number of pregnancies >20 weeks gestation). A backwards selection method was used for variable selection, and a P value of <0.10 was used to determine significance for variables in the model. RESULTS

From 2003 to 2013, 568 patients presented for POP surgery at Kingston General Hospital, and 455 of these women were ineligible for the study (Figure). The remainFigure. Flow chart of patient inclusion or exclusion.

ing 113 patients were included in the chart review, and 66 also completed the validated questionnaires. Long-term outcomes were thus obtained for 66 patients (58.4% response rate). Reasons for exclusion and for non-completion of questionnaires are detailed in the Figure. The median length of follow-up after surgery was 7 years (interquartile range 4−9 years). Demographic data and breakdown of types of surgical procedures performed (Table 1) were similar for all patients regardless of OSUI status. The main differences were seen in the surgical procedures used in the two groups and were expected. The UDS-positive group had significantly more patients undergoing an anti-incontinence procedure (generally either a Burch colposuspension or a tension-free vaginal tape [TVT, Gynecare, Ethicon, Cincinnati, OH]). Of the 113 eligible patients, 54 were UDS positive for OSUI, and 59 were UDS negative; 62 had POP-only surgery, and 52 had a concomitant SUI procedure (Table 2). For our primary outcome, we found that, of those women who responded to the long-term questionnaires, the overall rate of postoperative long-term validated subjective SUI was 24% (16 of 66): 19% (six of 31) in women who were UDS positive and 28.6% (10 of 35) in women who were UDS negative (Table 3; not significant (ns)). Forty-five patients in each group had clinic follow-up at 1 year, thus allowing us to assess our secondary outcome of the overall rate of short-term self-reported subjective SUI (secondary outcome). The rate was 11.1% (10 of 90) and was the same in the two groups, independent of whether they were UDS positive or UDS negative (Table 3). The overall ICIQ, UDI-6, and IIQ-7 scores were not different between UDS-positive and UDS-negative patients (Table 3). Irrespective of OSUI status, the rate of postoperative subjective SUI at 1 year was 7.5% (three of 40) in patients who underwent a concomitant anti-incontinence procedure and 14.0% (seven in 50) in those who did not (Table 4; ns). The overall questionnaire scores were not different between those patients who received a concomitant anti-incontinence procedure and those who did not for the ICIQ, UDI-6, and IIQ-7 questionnaires (Table 4). Overall, a trend towards a better ICIQ score was noted in the OSUI-positive women who had concomitant anti-incontinence surgery (Table 2). Logistic regression analysis was completed, with the outcome of long-term validated subjective SUI as the dependent variable; OSUI status and concomitant SUI surgery as independent variables regardless of significance; and age (years), body mass index (kg/m2), pre-CARE trial versus

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Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse?

Table 1. Chart review information for all eligible patients Preoperative urodynamic studies (n=113) Participant’s characteristics

Positive (n = 54)

Negative (n = 59)

P value

63.0 (11.4)

59.5 (11.6)

0.11

Age (years), mean (SD) Parity, median (IQR) BMI (kg/m2), median (IQR)

3.0 (2.0−3.3)

3.0 (2.0−3.0)

0.45

27.0 (25.0−30.0)

27.5 (25.0−31.0)

0.66

1

2

Unknown, n BMI classification (kg/m2), n (%) Normal

10 (18.9)

12 (21.1)

Overweight

27 (50.9)

22 (38.6)

Obese

16 (30.2)

23 (40.4)

1

2

Prior prolapse surgery, n (%)

5 (9.3)

12 (20.3)

0.12

Prior incontinence surgery, n (%)

2 (3.7)

6 (10.2)

0.28

Unknown

Smoking, n (%)

0.41

2 (3.7)

7 (11.9)

0.17

17 (31.5)

20 (33.9)

0.84

Lefort colpocleisis

10 (18.5)

6 (10.2)

0.28

Vaginal hysterectomy

10 (18.5)

6 (10.2)

0.28

McCall culdoplasty

11 (20.4)

4 (6.8)

0.10

Anterior colporrhaphy

19 (35.2)

21 (35.6)

1.00

Occasional preoperative SUI, n (%) Surgical procedures performed, n (%)a

Posterior colporrhaphy

21 (38.9)

30 (50.8)

0.26

Abdominal sacrocolpopexy

25 (46.3)

34 (57.6)

0.26

Paravaginal repair

21 (38.9)

24 (40.7)

1.00

Halban

19 (35.2)

33 (55.9)

0.04

Burch

24 (44.4)

8 (13.6)

0.0003

TVTO

16 (29.6)

0 (0.0)

<0.0001

TVTR

2 (3.7)

1 (1.7)

0.61

Kelly plication

0 (0.0)

1 (1.7)

1.00

Time since surgery (years), median (IQR)

a

6.5 (4.0−9.0)

8.0 (4.0−10.0)

0.26

≤2006 − pre-CARE trial, n (%)

17 (31.5)

24 (40.7)

0.31

≥2007 − post-CARE trial, n (%)

37 (68.5)

35 (59.3)

Most patients had a combination of multiple procedures.

BMI: body mass index; CARE: Colpopexy and Urinary Reduction Efforts; IQR: interquartile range; SUI: stress urinary incontinence; TVTO: tension-free vaginal tape obturator; TVTR; tension-free vaginal tape retropubic.

post-CARE trial, prior SUI surgery, and parity considered as covariates. Data from the 66 participants with complete long-term follow were used, and the analysis failed to identify a significant predictor of postoperative SUI (data not shown). Pelvic Organ Prolapse Surgery With or Without Concomitant Anti-incontinence Surgery

In patients who had POP surgery only (n = 62), the majority had a negative preoperative two-stage UDS result (80.6%) (Table 4). In patients who had POP surgery with concomitant SUI surgery (n = 51), the majority had

positive preoperative two-stage UDS results (82.4%) (Table 4). A trend for a higher rate of SUI on long-term follow-up was noted in those women who did not have concomitant SUI surgery: 29.7% versus 17.2% (ns). Among patients who had POP surgery only, a trend was noted in terms of a higher rate of long-term validated subjective SUI in women with preoperative OSUI compared with those without OSUI: 42.9% (three of seven) versus 26.7% (eight of 30), respectively (Table 2; ns). The 1-year postoperative subjective SUI rates were similar in women with OSUI compared with those without OSUI: 18.2%

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Table 2. The 1-year and long-term outcome follow-up based on preoperative urodynamic study results and antiincontinence surgery status Preoperative urodynamic studies positive (n = 54) [1] Prolapse and anti-incontinence surgery (n = 42)

[2] Prolapse surgery only (n = 12)

[3] Prolapse and anti-incontinence surgery (n = 9)

[4] Prolapse surgery only (n = 50)

Completed postoperative clinic follow-up at 1 year

n = 34

n = 11

n=6

n = 39

P value

Subjective stress urinary incontinence, n (%)

3 (8.8)

2 (18.2)

0 (0.0)

5 (12.8)

0.58,a 0.64b

n = 24

n=7

n=5

n = 30

P value

Validated subjective stress urinary incontinence, n (%)

3 (12.5)

3 (42.9)

2 (40.0)

8 (26.7)

0.11,a 0.40b

Validated subjective stress urinary incontinence of moderate severity or greater, n (%)

0 (0.0)

2 (28.6)

0 (0.0)

2 (6.7)

0.045,a 0.15b

3 (100.0)

1 (33.3)

2 (100.0)

6 (75.0)

0.22c

0 (0.0)

2 (66.7)

0 (0.0)

1 (12.5)

Outcomes

Completed long-term follow-up survey

Slightly Moderately Greatly

a

Preoperative urodynamic studies negative (n = 59)

0 (0.0)

0 (0.0)

0 (0.0)

1 (12.5)

ICIQ-SF score (out of 21), median (IQR)

1.5 (0.0−6.8)

3.0 (3.0−12.0)

9.0 (5.5−11.5)

4.0 (0.0−8.0)

UDI-6 score (out of 100), median (IQR)

12.5 (1.0−16.7)

IIQ-7 score (out of 100), median (IQR)

0.0 (0.0−4.7)

0.06c

16.7 (4.2−41.7) 25.0 (14.6−26.4) 14.6 (4.2−30.2)

0.25c

0.0 (0.0−14.3)

0.45c

4.8 (2.4−11.9)

0.0 (0.0−26.2)

Fisher exact - column [1] versus [2];

b

Fisher exact - column [2] versus [3];

c

Kruskal-Wallis.

ICIQ-SF: International Consultation on Incontinence Questionnaire Short Form; IIQ-7: Incontinence Impact Questionnaire Short Form; IQR: interquartile range; UDI-6: Urogenital Distress Inventory Short Form. Comparison of all four columns using the chi square is not valid because of small numbers.

Table 3. The 1-year and long-term outcome follow-up based on preoperative urodynamic study

Outcomes Prolapse and anti-incontinence surgery, n (%)

Preoperative urodynamic studies positive (n = 54)

Preoperative urodynamic studies negative (n = 59)

P value

42 (77.8)

9 (15.3)

<0.01

Completed postoperative clinic follow-up at 1 year

n = 45

n = 45

—

Subjective stress urinary incontinence, n (%)

5 (11.1)

5 (11.1)

1.00a

n = 31

n = 35

—

Validated subjective stress urinary incontinence of any severity, n (%)

6 (19.4)

10 (28.6)

0.41a

Validated subjective stress urinary incontinence of moderate severity or greater, n (%)

2 (6.7)

2 (5.7)

1.00a

Slightly

4 (66.7)

8 (80.0)

0.45b

Moderately

2 (33.3)

1 (10.0)

Greatly

0 (0.0)

1 (10.0)

ICIQ-SF score (out of 21), median (IQR)

3.0 (0.0−7.0)

5.0 (0.0−9.0)

0.12b

UDI-6 score (out of 100), median (IQR)

12.5 (4.2−20.8)

16.7 (4.2−29.2)

0.25b

IIQ-7 score (out of 100), median (IQR)

0.0 (0.0−4.8)

0.0 (0.0−14.3)

0.21b

Completed long-term follow-up survey

a

Fisher exact.

b

Mann-Whitney.

ICIQ-SF: International Consultation on Incontinence Questionnaire Short Form; IIQ-7: Incontinence Impact Questionnaire Short Form; IQR: interquartile range; UDI-6: Urogenital Distress Inventory Short Form.

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Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse?

Table 4. The 1-year and long-term outcome follow-up based on anti-incontinence surgery status

Outcomes Preoperative urodynamic studies positive, n (%)

Prolapse and anti-incontinence surgery (n = 51)

Prolapse surgery only (n = 62)

P value

42 (82.4)

12 (19.4)

<0.01

Completed postoperative clinic follow-up at 1 year

n = 40

n = 50

—

Subjective self-reported short-term stress urinary incontinence, n (%)

3 (7.5)

7 (14.0)

0.50a

n = 29

n = 37

—

Validated subjective stress urinary incontinence, n (%)

5 (17.2)

11 (29.7)

0.27a

Validated subjective stress urinary incontinence of moderate severity or greater, n (%)

0 (0.0)

4 (10.8)

0.12a

5 (100.0)

7 (63.6)

0.18b

Moderately

0 (0.0)

3 (27.3)

Greatly

0 (0.0)

1 (9.1)

ICIQ-SF score (out of 21), median (IQR)

3.0 (0.0−8.0)

4.0 (0.0-8.0)

0.41b

UDI-6 score (out of 100), median (IQR)

12.5 (4.2−22.9)

16.7 (4.2-31.2)

0.28b

IIQ-7 score (out of 100), median (IQR)

0.0 (0.0-4.8)

0.0 (0.0-19.0)

0.70b

Completed long-term follow-up survey

Slightly

a

Fisher exact.

b

Mann-Whitney.

ICIQ-SF: International Consultation on Incontinence Questionnaire Short Form; IIQ-7: Incontinence Impact Questionnaire Short Form; IQR: interquartile range; UDI-6: Urogenital Distress Inventory Short Form.

(two of 11) versus 12.8% (five of 39), respectively (Table 2; ns). Positive Versus Negative Preoperative Occult Stress Urinary Incontinence on Two-Stage Urodynamic Study

When women who were OSUI-positive on preoperative UDS were compared with women without OSUI, the presence or absence of concomitant anti-incontinence surgery statistically affected neither the rates of SUI over the longterm or at 1-year postoperatively nor the questionnaire scores (Table 3). In the OSUI-positive group, 42 (78%) patients had a concomitant anti-incontinence procedure (Table 2). Longterm rates of validated subjective SUI tended to be lower in women with concomitant SUI surgery: 12.5% (three of 24) versus 42.9% (three of seven) (ns). Regarding the selfreported presence of SUI 1 year postoperatively (n = 45), fewer women tended to report SUI among those who received concomitant SUI surgery: 8.8% (three of 34) versus. 18.2% (two of 11) (ns). In the OSUI-negative group, nine (15.3%) patients had a concomitant anti-incontinence procedure (Table 2). In the long term, 40% of patients (two of five) in the anti-incontinence procedure group had postoperative SUI, as compared with 26.7% (eight of 30) of the POP surgery-only group (ns). With regard to self-reported subjective 1-year

SUI, fewer women tended to report postoperative SUI among those who had concomitant SUI surgery: 0% (none of six) versus 12.8% (five of 39) (ns). Postoperative Follow-Up Treatment for Stress Urinary Incontinence

Of the 66 patients who responded to the long-term followup questionnaires, six (9.1%) indicated that they had received postoperative additional treatment in the form of surgery for SUI. Before surgery, five of six received pelvic floor physiotherapy, and one of six also attempted treatment with a pessary. All of these patients were from the POP surgery-only group, and five of six (83.3%) were negative for OSUI on preoperative two-stage UDS. Pelvic Organ Prolapse Surgery, Concomitant AntiIncontinence Surgery, and the CARE Trial

A comparison of 1-year and long-term outcomes following POP surgery with and without a concomitant anti-incontinence procedure before and after the publication of the CARE trial results can be seen in Table 5. In the period following the CARE trial, a greater proportion of patients elected to proceed with a concomitant anti-incontinence procedure: 37 of 72 (51.4%) versus 14 of 41 (34.1%) (ns). The rate of subjective postoperative SUI 1 year postoperatively was lower across all patients following the CARE trial’s publication, but the difference was not statistically significant: 8.9% (five of 56) post-CARE versus 14.7% (five of 34) pre-CARE. No statistically significant differences in 1-

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Table 5. The 1-year and long-term outcome follow-up based on anti-incontinence surgery status and pre-CARE versus post-CARE trial Pre-CARE trial (n = 41)

Outcomes Preoperative urodynamic studies positive, n (%) Completed postoperative clinic follow up at 1 year Subjective self-reported short-term stress urinary incontinence, n (%)

[2] Prolapse [3] Prolapse and surgery anti-incontinence only (n = 27) surgery (n = 37)

[4] Prolapse surgery only (n = 35)

P value —

12 (85.7)

5 (18.5)

30 (81.1)

7 (20.0)

n = 12

n = 22

n = 28

n = 28

2 (16.7)

3 (13.6)

1 (3.6)

4 (14.3)

— a

0.42, 1.00,b 1.00,c 0.35d

n=9

n = 16

n = 20

n = 21

—

Validated subjective stress urinary incontinence, n (%)

3 (33.3)

4 (25.0)

2 (10.0)

7 (33.3)

0.31,a 1.00,b 0.89,c 0.15d

Validated subjective stress urinary incontinence of moderate severity or greater, n (%)

0 (0.0)

1 (6.3)

0 (0.0)

3 (14.3)

1.00,a 1.00,b 0.83,c 0.25d

3 (100.0)

3 (75.0)

2 (100.0)

4 (57.1)

0.28e

0 (0.0)

1 (25.0)

0 (0.0)

2 (28.6)

Completed long-term follow up survey

Slightly Moderately Greatly

a

[1] Prolapse and anti-incontinence surgery (n = 14)

Post-CARE trial (n = 72)

0 (0.0)

0 (0.0)

0 (0.0)

1 (14.3)

ICIQ-SF score (out of 21), median (IQR)

3.0 (0.0−9.0)

4.5 (3.0−6.8)

4.0 (0.0−8.5)

3.0 (0.0−10.5)

0.86e

UDI-6 score (out of 100), median (IQR)

8.3 (0−20.8)

18.8 (1.0−36.5)

0.49e

IIQ-7 score (out of 100), median (IQR)

0 (0−19.0)

0 (0−19.0)

0.98e

14.6 (5.2−25.0) 12.5 (8.3−24.0) 0 (0−26.2)

0 (0−4.7)

Fisher exact - column [1] versus [3].

b

Fisher Exact - column [1] versus [2].

c

Fisher exact - column [2] versus [4].

d

Fisher exact - column [3] versus [4].

e

Kruskal-Wallis.

CARE: Colpopexy and Urinary Reduction Efforts; ICIQ-SF: International Consultation on Incontinence Questionnaire Short Form; IIQ-7: Incontinence Impact Questionnaire Short Form; IQR: interquartile range; UDI-6: Urogenital Distress Inventory Short Form. Comparison of all four columns using the chi square is not valid because of small numbers.

year or long-term outcomes were observed when comparing groups who underwent POP surgery with and without a concomitant anti-incontinence procedure before and after the publication of the CARE Trial results (Table 5). DISCUSSION

This research determined the rate of postoperative SUI in a group of women with no SUI or rare SUI who were counselled on the value of adding anti-incontinence surgery at the time of POP surgery to prevent OSUI in the era following the CARE and OPUS trials, where antiincontinence procedures were shown to decrease postoperative SUI. Patients were guided and informed, but ultimately they chose whether or not to undergo concomitant SUI surgery. This is a pragmatic trial showing real-world results. In answering our first question, addressing the value of two-stage UDS testing, our results demonstrated a trend for a higher risk of postoperative SUI in patients with

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positive test results who did not have concomitant SUI surgery, compared with those women who did. This was particularly evident in the long-term results. For patients with negative UDS test results, the rates of postoperative SUI in those without a concomitant procedure remained sufficiently low that we feel comfortable in advising patients that they have a low risk of postoperative SUI and that a “two-stage” approach of fixing the POP followed by anti-incontinence surgery is an option. Our second question assessed the impact of a concomitant anti-incontinence procedure on postoperative SUI. Pooled results of all patients showed a non-statistically significant decrease in postoperative SUI in the short and long term among patients who underwent a concomitant anti-incontinence procedure. These findings were largely maintained when patients were stratified by OSUI status. These results are consistent with those of the CARE trial subgroup analysis and approach those of Liapis et al.,8 whose cohort was of similar size to ours. Liapis et al. reported a postoperative SUI rate of 23% at 3 months and a long-term rate of

Testing for Occult Stress Urinary Incontinence in Patients With Pelvic Organ Prolapse?

43.6% at 2 years in OSUI-positive patients who did not undergo concomitant SUI surgery.8 The CARE trial was significantly larger (n = 322) and had a higher rate of SUI at 3 months (60%) in OSUI-positive patients who did not undergo anti-incontinence surgery.

because this would require a reliance on patient recall for the onset of SUI symptoms.

There was a contradictory finding in the OSUI-negative group wherein the rate of postoperative SUI was higher in the long term for the anti-incontinence procedure group. We believe that analysis of this result is of limited value because of the small sample size (n = 5) in that group, thus leading to high instability of results.

This study demonstrates the challenges of relying on twostage UDS as a clinical tool in surgical decision making in the setting of POP in women with no SUI or rare SUI. To be sure, this area of study would benefit from a randomized controlled trial focused on OSUI that would allow calculation of specificity and sensitivity as well as a larger study of optimal methods of POP reduction. According to our study and previous research on this topic, a positive UDS result indicates a clinically relevant risk of postoperative SUI, and a negative UDS result provides some reassurance, although it is not sufficient to rule out postoperative SUI as a complication; decisions should thus be made in collaboration with patients. Additionally, we were able to show the real-world rate of SUI after patient-centred decision making following evidence-based counselling. Most women with OSUI noted on preoperative UDS findings chose to have concomitant anti-incontinence surgery, and most women who did not have OSUI chose not to, despite published evidence suggesting a benefit of concomitant SUI surgery for all women. Finally, we noted that following the publication of the CARE trial, more women opted for concomitant anti-incontinence surgery, irrespective of preoperative UDS findings, with a trend for better results.

Our results have several possible implications for the use of POP reduction during UDS for the detection of OSUI. The finding that patients with negative UDS test results who do not undergo an anti-incontinence procedure still present with postoperative SUI after 1 year suggests that the testing is not capturing all OSUI cases. This could reflect the reduction technique (pessary) used in our centre. Manual reduction and reduction with a speculum or swab are alternative reduction methods. Preliminary data from Visco et al. had suggested that the speculum method identified the greatest number of cases and that the swab had the highest positive predictive value.6 There were a number of key strengths of this investigation. We have validated long-term outcome data with a median of 7 years, up to 10 years postoperatively, that provide useful information for patient counselling. As opposed to multicentre studies, all patients reviewed for this research had the UDS procedure completed at the same facility, with a standardized testing method and with only two physicians reading the results. Finally, the response rate for the long-term follow-up survey was 58.4%. Given that some patients had their procedures as much as 10 years earlier, this response rate is very strong. Several limitations should also be noted. First, because this study was retrospective, patients were not randomized to treatment, with a resulting imbalance in cohort sizes across treatment categories. Given the relatively small cohort of patients at our centre, the study was underpowered to detect a difference of 20% between OSUI-positive and OSUI-negative patients. We also were not able to obtain 100% completion of long-term follow-up, thus limiting the sample size further for that analysis. For the 1-year followup data, we did not have consistent use of validated questionnaires to quantify postoperative SUI. Given that this was a retrospective study, this was a non-modifiable factor. For the long-term follow-up, we were not able to perform a Kaplan-Meier analysis to determine when SUI recurred

CONCLUSION

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8. Liapis A, Bakas P, Georgantopoulou C, et al. The use of the pessary test in preoperative assessment of women with severe genital prolapse. Eur J Obstet Gynecol Reprod Biol 2011;155:110–3. 9. Van der Ploeg JM, van der Steen A, Rengerink KO, et al. Prolapse surgery with or without stress incontinence surgery for pelvic organ prolapse: a systematic review and meta-analysis of randomised trials. Br J Obstet Gynaecol 2014;121:537–47. 10. Uebersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess life quality and symptom distress for urinary incontinence in women: the

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Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 1995;14:131–9. 11. Avery K, Donovan J, Peters TJ, et al. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23:322–30. 12. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Subcommittee of the International Continence Society. Neurourol Urodyn 2002;21:167–78.