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original article

T he n e w e n g l a n d j o u r n a l o f medicine

n engl j med 366;25 nejm.org june 21, 20122358

A Midurethral Sling to Reduce Incontinence

after Vaginal Prolapse RepairJohn T. Wei, M.D., Ingrid Nygaard, M.D., Holly E. Richter, Ph.D., M.D.,Charles W. Nager, M.D., Matthew D. Barber, M.D., M.H.S., Kim Kenton, M.D.,

Cindy L. Amundsen, M.D., Joseph Schaffer, M.D.,Susan F. Meikle, M.D., M.S.P.H., and Cathie Spino, D.Sc.,

for the Pelvic Floor Disorders Network

From the University of Michigan, AnnArbor (J.T.W., C.S.); the University ofUtah, Salt Lake City (I.N.); the Universityof Alabama at Birmingham, Birmingham(H.E.R.); the University of California, SanDiego, San Diego (C.W.N.); ClevelandClinic, Cleveland (M.D.B.); Loyola Uni-versity, Chicago (K.K.); Duke University,Durham, NC (C.L.A.); the University ofTexas Southwestern, Dallas (J.S.); andthe Eunice Kennedy Shriver National In-stitute of Child Health and Human De-velopment, Bethesda, MD (S.F.M.). Ad-dress reprint requests to Dr. Wei at the

Department of Urology, University ofMichigan, 2800 Plymouth Rd., Bldg. 520,Rm. 3192, Ann Arbor, MI 48109-2800, orat [email protected].

N Engl J Med 2012;366:2358-67.Copyright 2012 Massachusetts Medical Society.

A B S T RA C T

BACKGROUND

Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethralsling may be placed at the time of prolapse repair to reduce this risk.

METHODS

We performed a multicenter trial involving womenwithout symptoms of stress in-continence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Pro-lapse Quantification system examination) who were planning to undergo vaginalprolapse surgery. Women were randomly assigned to receive either a midurethralsling or sham incisions during surgery. One primary end point was urinary incon-tinence or treatment for this condition at 3 months. The second primary end pointwas the presence of incontinence at 12 months, allowing for subsequent treatmentfor incontinence.

RESULTS

Of the 337 women who underwent randomization, 327 (97%) completed follow-upat 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% inthe sling group and 49.4% in the sham group (P

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Midurethral Sling af ter Vaginal Prolapse Repair

n engl j med 366;25 nejm.org june 21, 2012 2359

One in five women will undergo sur-

gery for pelvic-organ prolapse in her life-time,1and urinary incontinence commonly

occurs with pelvic-organ prolapse. In previouslycontinent women with pelvic-organ prolapse,urinary incontinence develops in approximately aquarter of them after prolapse repair; this phenom-

enon is referred to as occult, latent, de novo, iatro-genic, or potential stress urinary incontinence.2

In 2006, the Colpopexy and Urinary Reduc-tion Efforts (CARE) trial2showed that adding abladder-neck suspension at the time of abdomi-nal prolapse surgery in women without preop-erative stress incontinence significantly reducedthe risk of postoperative stress urinary inconti-nence (23.8%, vs. 44.1% in the control group).Recently, prolapse repairs have been increasinglyperformed transvaginally, and midurethral slingshave largely replaced bladder-neck suspensions.3

Extrapolating from the CARE trial data, manysurgeons prophylactically insert a concomitantmidurethral sling in all continent women under-going vaginal prolapse surgery4; others performthis additional procedure selectively, in womenwho have urinary stress incontinence on preop-erative cough testing.5An alternative strategy isto treat only those women in whom bothersomeurinary incontinence develops postoperatively.4The relative benefits and risks of these strategiesare unclear.

We designed the Outcomes Following VaginalProlapse Repair and Midurethral Sling (OPUS)trial6to determine whether, among women with-out stress incontinence who undergo vaginal pro-lapse surgery, the prevalence of urinary inconti-nence or treatment at 3 months and the prevalenceof urinary incontinence (regardless of intervaltreatment) at 12 months differed with and with-out a concomitant midurethral sling. We alsoevaluated the role of preoperative prolapse-reduc-tion stress testing and included an assessmentof outcomes among women who declined to un-

dergo randomization (patient-preference cohort).

METHODS

STUDY DESIGN

We conducted this multicenter, randomized, sin-gle-blind, sham-controlled, surgical-interventiontrial at seven clinical sites. The methods have beenpublished previously.6The study protocol was ap-proved by the institutional review board at each

site and is available with the full text of this ar-ticle at NEJM.org. The last author vouches for theaccuracy and completeness of the reported dataand for the fidelity of the study to the protocol.Participants provided written informed consent.Enrollment began in May 2007, and follow-up wascompleted in January 2011.

PATIENT POPULATION

Eligible participants were women planning to un-dergo vaginal prolapse surgery who reported thesymptom of feeling or seeing a vaginal bulge butreported no symptoms of stress incontinence,which was defined as a positive response to anyof the three questions regarding stress inconti-nence on the Pelvic Floor Distress Inventory.6,7On pelvic examination, the anterior vaginal-wallprolapse had to be within 1 cm of the hymenalring with straining. Women were excluded if they

had undergone previous sling placement, were re-ceiving treatment for stress urinary incontinence,had contraindications for a midurethral sling (pri-or urethral surgery or pelvic irradiation), wereplanning pregnancy in the first year after sur-gery, or had a history of two or more hospitaliza-tions for medical illnesses in the previous year.

STUDY INTERVENTION AND RANDOMIZATION

At the time of vaginal prolapse surgery, womenwere randomly assigned to receive either a retro-pubic midurethral sling (Gynecare TVT, Ethicon)(the sling group) or two 1-cm suprapubic, super-ficial sham incisions, which mimicked the slingincisions (the sham group). Ethicon, the maker ofthe Gynecare TVT midurethral sling, was not in-volved in the study and did not provide funding orslings. Randomization, with the use of a permutedblock design, was stratified according to surgeonand type of prolapse surgery (colpocleisis, apicalsuspension, or anterior repair). Women who de-clined to undergo randomization were offered theopportunity to participate in a patient-preference

cohort in which the decision for a sling was leftup to the patient and her surgeon.

STUDY MEASURES

Baseline assessments included the collection ofdemographic and general health data, examinationfor prolapse,8a measurement of postvoiding resid-ual volume, and a preoperative prolapse-reductionstress test (at a bladder volume of 300 ml, withthe prolapsed organ repositioned inside the va-

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Th e n e w e n g l a n d j o u r n a l o f medicine


gina with the use of one or two large swabs); thetest was considered negative if the woman had noleakage with coughing or straining in either thesupine or standing position. We also collectedscores on the Medical Outcomes Study 36-ItemShort-Form Health Survey (with normalized val-ues having a mean of 50 and a standard deviation

of 10 and higher scores indicating better healthstatus),9the Pelvic Floor Distress Inventory (withscores on the Urinary Distress Inventory subscaleand prolapse subscale ranging from 0 to 300, scoreson the colorectalanal subscale ranging from 0 to400, and higher scores indicating more symp-toms),7the Pelvic Floor Impact Questionnaire (withscores ranging from 0 to 400 and higher scoresindicating a greater negative effect on quality oflife),7the Incontinence Severity Index (with scoresranging from 1 to 12 and higher scores indicat-ing more severe incontinence),10the Pelvic Organ

Prolapse/Urinary Incontinence Sexual Function-ing Questionnaire Short Form (with scores rang-ing from 0 to 48 and higher scores indicatingbetter sexual function),11and a visual analoguepain scale adapted for suprapubic pain (with scoresranging from 0 to 10 and higher scores indicat-ing more pain).12All surveys were administeredby centralized telephone interviewers. Participantsin the randomized cohort, interviewers, and co-ordinators were unaware of study-group assign-ments, and operative notes and surgical-consentforms did not reveal the study group.

Follow-up at 3, 6, and 12 months consisted ofa medical history taking, administration of thesurveys noted above, and an assessment of pro-lapse severity.8A cough stress test, urinalysis, andmeasurement of postvoiding residual volume wereperformed at 3 and 12 months.

STUDY OUTCOMES

The two primary study end points6(Table 1 in theSupplementary Appendix, available at NEJM.org)were urinary incontinence (stress, urge, or mixed)

at 3 months, defined as a positive cough stress test,bothersome incontinence symptoms, or treatmentfor urinary incontinence, and urinary incontinence(stress, urge, or mixed) at 12 months, regardlessof whether interim treatment for incontinence hadbeen provided.

Secondary outcomes included measures of in-continence and quality of life (as noted above).Serious adverse events, expected complications(common complications attributable to slings), and

unexpected nonserious adverse events were sys-tematically ascertained. An independent data andsafety monitoring board convened quarterly toreview study conduct, adverse events, and interimanalyses.

STATISTICAL ANALYSIS

For the randomized cohort, we calculated that150 participants per group would provide thestudy with 80% power to detect a 15% between-group difference in the primary 3-month endpoint on the basis of a two-sample test of propor-tions, with a two-sided significance level of 5%.Given that the primary 12-month end point ad-dresses a distinct hypothesis, we did not adjustfor multiple comparisons and we estimated thatthe study would have 80% power to identify a15% between-group difference. The f irst interimanalysis was completed and reviewed by the data

and safety monitoring board; however, a secondplanned interim analysis was not performed be-cause enrollment ended earlier than anticipated.Thus, the nominal significance level was 0.0469for the primary 3-month end point. A signifi-cance level of 5% was used for all other hypoth-esis testing.

The primary analyses for the randomized trialcompared the proportion of participants who hadurinary incontinence or had received treatmentfor it at 3 months and who had urinary inconti-nence at 12 months between the sling and thesham groups with the use of conditional logisticregression, stratif ied according to surgeon, withcovariates for treatment and planned surgical re-pair, providing odds ratios for the treatment effect.To estimate the corresponding relative risks, weused a generalized linear model that was based onthe binomial distribution with a log link, adjustingfor planned surgical repair and including surgeonas a random effect.13The analysis was based onan intention-to-treat approach, with participantswho withdrew from the study or were missing

components of the composite end point consid-ered to have had treatment failures. Sensitivityanalyses were performed to assess the effect ofmissing data by imputing treatment success inthese cases instead of treatment failure and ana-lyzing complete cases. Baseline characteristics,changes in quality-of-life measures, and adverseevents were compared between the randomizedgroups with the use of Fishers exact test or thechi-square test for discrete variables and with the




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use of Students t-test or the Wilcoxon signed-rank test for continuous variables. A similar ap-proach was used to look for differences betweenthe randomized and patient-preference cohortsas a measure of participation bias. An additionalplanned secondary analysis was a subgroupanalysis that was based on the results of thepreoperative prolapse-reduction stress test. Toassess effect modification by this variable, weincorporated an interaction term in the condi-tional logistic model.14 All analyses were per-formed with the use of SAS software, version 9.2(SAS Institute).

RESULTS

STUDY POPULATION

Between May 2007 and October 2009, a total of517 women presenting to the clinical sites forprolapse repair were screened for eligibility, and337 underwent randomization (Fig. 1). Two par-ticipants in the sling group did not receive asling; all participants in the sham group received

sham incisions. Of those who underwent random-ization, 327 (97%) completed follow-up at 1 year;306 (91%) underwent evaluation for the primaryoutcome at 3 months, and 287 (85%) at 12 months.The baseline demographic and clinical character-istics were similar between the two groups (Table1, and Table 2 in the Supplementary Appendix).

The patient-preference cohort had 129 partici-pants, with 64 receiving slings (Fig. 1). As com-pared with participants in the randomized trial,women in the patient-preference cohort were morelikely to be white (95.4% vs. 84.9%, P = 0.02) andto have received only an apical-prolapse suspen-

sion (34.9% vs. 22%, P = 0.01); other baselinedemographic and clinical characteristics did notdiffer significantly between the two groups (Ta-ble 3 in the Supplementary Appendix).

RANDOMIZED-TRIAL COHORT

Three-Month Outcomes

Three months after surgery, the rate of urinaryincontinence or treatment for it was 23.6% in thesling group and 49.4% in the sham group (ad-

517 Patients were assessed for eligibility

51 Withdrew during screening or didnot meet entry requirements

337 Underwent randomization129 Were assigned to patient-preference

cohort

3 Were lost tofollow-up

2 at 3 mo

1 at 12 mo

165 Were included in intention-to-treat analysis


1 at 3 mo

6 at 12 mo


1 at 3 mo

5 at 12 mo


1 at 3 mo

3 at 12 mo

165 Were assigned to undergoprolapse repair plus sling

172 Were assigned to undergoprolapse repair plus sham

64 Underwent prolapse repairplus sling

65 Underwent prolapse repairplus sham




Figure 1.Enrollment, Randomization, and Analysis.

Of 517 patients who were assessed for eligibility, 337 were randomly assigned to receive a midurethral sling or sham incisions, 129 de-cided to participate in a patient-preference cohort, and 51 withdrew or did not meet eligibility requirements. Data from the women inthe randomized and patient-preference cohorts were included in the intention-to-treat analyses.




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justed odds ratio, 0.31; 95% confidence interval[CI], 0.19 to 0.50; P

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in generic health (Table 3), other pelvic-floor symp-toms, effect on quality of life, sexual function, orpain (Table4 in the Supplementary Appendix).ADVERSE EVENTS

The rates of serious or unexpected adverse eventsdid not differ significantly between groups at theend of the trial (Table4, and Tables 7 and 8 in theSupplementary Appendix). The mean operativetime was 11.4 minutes longer and the mean esti-mated blood loss 24 ml higher in the sling groupthan in the sham group (P = 0.05 and P = 0.03,respectively). Rates of bladder perforation, urinary

tract infection, major bleeding complications, andincomplete bladder emptying in the first 6 weeksafter surgery were all higher in the sling group

than in the sham group (Table4). There were nomesh erosions resulting from sling placement.

Bladder perforations due to sling placement wereall managed during surgery without long-termconsequences.

PREOPERATIVE PROLAPSE-REDUCTION STRESS TEST

Overall, 33.5% of women (111 of the 331 patientswho completed a baseline prolapse-reduction stresstest) had a positive prolapse-reduction stress test

Table 2.End Points at 3 and 12 Months, According to Study Group in the Randomized-Trial Cohort.

End PointSling

(N = 165)Sham

(N = 172)

Difference, Slingvs. Sham(95% Cl)*

Adjusted OddsRatio

(95% Cl) P Value

percentage points

At 3 mo

Urinary incontinence or treatment no. (%)

39 (23.6) 85 (49.4) 25.8 (36.1 to 15.5) 0.31 (0.19 to 0.50)

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before surgery. Among these women, 29.6% inthe sling group, as compared with 71.9% inthe sham group, had urinary incontinence at3 months (adjusted odds ratio, 0.13; 95% CI, 0.05to 0.34) (Table 5 in the Supplementary Appen-dix). Women with a positive prolapse-reductionstress test before surgery appeared to receive

more benefit from a sling at 3 months than didthose with a negative test (P = 0.06 for interac-tion), although this difference was not signifi-cant at 12 months (P = 0.16 for interaction).

PATIENT-PREFERENCE COHORT

Women in the patient-preference cohort who hada positive prolapse-reduction stress test were morelikely to undergo a sling procedure at the time ofprolapse repair than those who had a negativetest (57.8% vs. 22.2%, P

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nence at 3 months was lower among women whoreceived a sling than among those who did not(adjusted odds ratio, 0.31; 95% CI, 0.11 to 0.86).At 12 months, rates of urinary incontinence inthe two groups were similar to those in the ran-

domized trial, but differences were not signifi-cant (Table 6 in the Supplementary Appendix).

DISCUSSION

In our randomized trial of sling placement versussham placement in women without preoperativesymptoms of stress incontinence who were plan-ning to undergo vaginal surgery for apical or an-

terior prolapse, the odds of urinary incontinenceor treatment for urinary incontinence 3 monthsafter surgery among the women in the sling groupwere substantively reduced, as compared withthose in the sham group. The beneficial effect of

the sling on urinary incontinence remained sig-nificant at 12 months. A benefit was observedregardless of the results of preoperative prolapse-reduction stress testing; there was modest evi-dence (P = 0.06) to suggest that at 3 months, pa-tients with a positive prolapse-reduction stress testbefore surgery may have received more benefitthan those with a negative test, but this was notapparent at 12 months.

Table 3.(Continued.)

VariableSling Group

(N = 165)Sham Group

(N = 172)

Difference, Slingvs. Sham(95% Cl) P Value

UDI irritative symptom subscale

At 3 mo

No. of patients 160 158

Score change 12.518.83 10.517.06 2.0 (6.0 to 2.0) 0.33

At 12 mo


Score change 10.917.15 11.615.87 0.6 (3.0 to 4.3) 0.73

UDI stress subscale

At 3 mo


Score change 5.116.29 4.220.42 9.4 (13.5 to 5.3)

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A recent survey study of 132 women who un-derwent vaginal prolapse surgery and had anegative prolapse-reduction stress test beforesurgery showed that 42% had postoperative uri-nary incontinence, as assessed by subjective cri-teria, which was similar to the 38% rate in ourstudy.15 Moreover, approximately one third ofparticipants who responded to the survey weremoderately or greatly bothered by their symptoms,and 5% underwent surgery for these symptoms.

These findings highlight the potential role foreffective preventive strategies.Our results support earlier findings of the

CARE trial,2 in which the addition of a Burchcolposuspension at the time of abdominal pro-lapse surgery reduced the incidence of postop-erative stress urinary incontinence. A smaller ran-domized trial involving women undergoing vaginalprolapse repair, which was limited to women withoccult stress incontinence, showed a 4% rate of

incontinence, as assessed by subjective criteria,at 2 years among women who received a sling,as compared with a rate of 36% among womenin the control group.5The absence of blinding inthat trial may in part explain the greater ob-served difference between groups. When the endpoint includes a subjective component, it is par-ticularly important that participants and out-come assessors be unaware of the study-groupassignments.

From the perspective of the individual patient,benefits must be balanced against the higherrates of clinically relevant adverse effects and theneed for additional surgery. In our trial, nearly5% of the women in the sham group underwenta sling procedure in the first 12 months afterprolapse-repair surgery. In contrast, surgery toremove the sling was required in only 2.4% ofwomen in the sling group.

Findings in the patient-preference cohort were

Table 4.Adverse Events during the First Year after Surgery, According to Study Group in the Randomized-Trial Cohort.*

EventSling

(N = 165)Sham

(N = 172) P Value

Serious adverse events no. of patients (%) 28 (17.0) 20 (11.6) 0.16

Unexpected adverse events no. of patients (%) 14 (8.5) 14 (8.1) 1.0

Ureteral injury 6 (3.6) 3 (1.7) 0.33

Other 8 (4.8) 11 (6.4) 0.64

Expected adverse events no. of patients/total no. (%)

Bladder perforation during sling placement 11/164 (6.7) 0/172

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remarkably consistent with those in the random-ized cohort, suggesting that nonparticipation biasprobably had a minimal effect on the study f ind-ings. Not surprisingly, once women chose to par-ticipate in the patient-preference cohort, thosewith a positive preoperative stress test were morelikely to undergo surgery to receive a sling, sug-

gesting that knowledge of the results of the stresstest may have inf luenced the decisions of partici-pants and their surgeons.

The limitations of our study should be con-sidered. It is possible that the incidence of post-operative incontinence may differ according to thetype of anterior repair or apical suspension, but ourstudy was not powered to assess these subgroups.Participant knowledge of the study interventionmay have had an effect on the subjective out-comes; however, our strategies for masking shouldhave lessened this risk. Some women may have

been unwilling to undergo another surgery with-in the first year, even if they had symptoms. Fi-

nally, our findings should not be extrapolatedbeyond 12 months, although the benefits of slingplacement with concomitant prolapse surgery forthe treatment of incontinence have been shownto be durable beyond 1 year.16

Adding a midurethral sling at the time of vagi-nal-prolapse surgery in women without preop-

erative symptoms of stress urinary incontinencereduces the likelihood of urinary incontinence at3 and 12 months after surgery but increases thelikelihood of adverse events. Counseling of wom-en who are planning to undergo vaginal-prolapsesurgery should include attention to both the ben-efits and the risks of sling placement.

Supported by grants from the Eunice Kennedy Shriver Na-tional Inst itute of Child Health and Human Development (2U01HD41249, 2U10 HD41250, 2U10 HD41261, 2U10 HD41267, 1U10HD54136, 1U10 HD54214, 1U10 HD54215, and 1U10 HD54241)and the National Institutes of Health Office of Research on

Womens Health.Disclosure forms provided by the authors are available with

the full text of this article at NEJM.org.

REFERENCES

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et al. Retropubic versus transobturatormidurethral slings for stress inconti-nence. N Engl J Med 2010;362:2066-76.4. Fatton B. Is there any evidence to advo-cate SUI prevention in continent womenundergoing prolapse repair? An overview.Int Urogynecol J Pelvic Floor Dysfunct2009;20:235-45.5. Meschia M, Pifarotti P, SpennacchioM, Buonaguidi A, Gattei U, Somigliana E.A randomized comparison of tension-freevaginal tape and endopelvic fascia plica-tion in women with genital prolapse andoccult stress urinary incontinence. Am JObstet Gynecol 2004;190:609-13.6. Wei J, Nygaard I, Richter H, et al. Out-

comes following vaginal Prolapse repairand mid Urethral Sling (OPUS) Trial design and methods. Clin Trials 2009;6:162-71.

7. Barber MD, Kuchibhatla MN, PieperCF, Bump RC. Psychometric evaluation of2 comprehensive condition-specific qual-ity of life instruments for women withpelvic floor disorders. Am J Obstet Gyne-col 2001;185:1388-95.8. Bump RC, Mattiasson A, B K, et al.The standardization of terminology of fe-male pelvic organ prolapse and pelvic f loor

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12. Hartanto VH, DiPiazza D, AnkemMK, Baccarini C, Lobby NJ. Comparisonof recovery from postoperative pain uti-lizing two sling techniques. Can J Urol2003;10:1759-63.13. McNutt LA, Wu C, Xue X, Hafner JP.Estimating the relative risk in cohortstudies and clinical trials of common out-comes. Am J Epidemiol 2003;157:940-3.

14. Selvin S. Statistical analysis of epide-miological data. New York: Oxford Uni-versity Press, 1996.15. Al-Mandeel H, Ross S, Robert M,Milne J. Incidence of stress urinary in-continence following vaginal repair ofpelvic organ prolapse in objectively conti-nent women. Neurourol Urodyn 2011;30:390-4.16. Schraffordt Koops SE, Bisseling TM,van Brummen HJ, Heintz AP, Vervest HA.Result of the tension-free vaginal tape inpatients with concomitant prolapse sur-gery: a 2-year follow-up study: an analysisfrom the Netherlands TVT database. IntUrogynecol J Pelvic Floor Dysfunct 2007;

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