Objective
The purpose of this study was to assess prospectively the effects of midurethral sling surgery on sexual function and activity.
Study Design
Sexual activity and function was assessed in 597 women with stress urinary incontinence who were enrolled in a randomized equivalence trial of retropubic compared with transobturator midurethral slings. Repeated measures analysis of variance was used to assess changes in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores over a 2-year period.
Results
Significant, similar improvements in sexual function were seen in both midurethral sling groups. Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores increased from 32.8 at baseline to 37.6 at 6 months and 37.3 at 24 months ( P < .0001). Dyspareunia, incontinence during sex, and fear of incontinence during sex each significantly improved after surgery. Preoperative urge incontinence was associated with abstinence after surgery ( P = .02); postoperative urge incontinence negatively impacted sexual function ( P = .047).
Conclusion
Midurethral sling surgery for stress urinary incontinence significantly improves sexual function, although coexistent urge incontinence has a negative impact.
Urinary incontinence (UI) is estimated to affect approximately 40% of adult women. Women with UI report decreased sexual activity and worse sexual function as a result of a loss of urine with sexual activity, embarrassment, and fear of leakage. Importantly, incontinence-related sexual dysfunction negatively impacts overall quality of life in sexually active women. Although stress UI (SUI) surgery is thought to improve sexual function, complications of synthetic mesh midurethral slings (MUS), which include de novo or exacerbated voiding dysfunction, mesh exposure, and paraurethral banding, may each adversely affect postoperative sexual function. Moreover, it is not known whether differences in the path of extrapelvic mesh between the sling routes or the extent of mesh within the anterior vaginal wall may affect sexual function. We performed a planned secondary analysis of women who were enrolled in the Trial of Midurethral Slings (TOMUS) study to assess prospectively the overall impact of MUS on sexual function over a period of 2 years after surgery and to identify factors that are associated with change in sexual function.
Materials and Methods
TOMUS was a multicenter, randomized equivalence trial in which women (n = 597) with stress predominant UI were assigned randomly at the time of surgery to either a retropubic or transobturator MUS. Eligible participants reported symptoms of either pure or predominant SUI for at least 3 months and demonstrated a positive standardized stress test. Key elements of the surgical procedures that included cystoscopy were standardized. Concomitant vaginal procedures were permitted; however, surgery could not include the use of any synthetic graft or anterior compartment biologic graft. All sites obtained local institutional review board approval, and participants provided written informed consent. A detailed description of the TOMUS trial and the primary results have been published previously.
Information was obtained from clinical examinations, patient interviews, and self-administered questionnaires before surgery and at in-person postoperative visits that were conducted at 2 and 6 weeks and at 6, 12, and 24 months. Sexual function was assessed with the Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The PISQ-12 is a condition-specific, validated, and reliable instrument that was designed to evaluate sexual function in women with UI and/or pelvic organ prolapse. This tool is able to distinguish women with poor sexual function as measured on the Sexual History Form -12. The PISQ-12 provides a single sexual function score that incorporates behavioral-emotive factors, physical factors, and partner-related factors. The maximum total score is 48; higher scores represent better sexual function. Because of protocol-recommended limitations on intravaginal sexual activity during the first 6 weeks after surgery, the PISQ-12 was first administered after surgery at the 6-month visit. We also calculated the proportion of enrolled women who reported that they were sexually active at baseline and at 6, 12, and 24 months after surgery.
Overall surgical failure was defined by the occurrence of any of the following objective outcomes: a positive stress test, positive 24-hour pad test, or any type of retreatment for SUI. Self-reported urge-type UI was quantified with the Medical, Epidemiologic, and Social Aspects of Aging Project questionnaire. An index score was calculated from responses to questions that refer to urine loss preceded by an urge to void or uncontrollable voiding with little or no warning. The urge index has a response range from 0 (no urge symptoms) to 100 (all symptoms reported “often”).
For evaluation of changes over time after surgery in mean sexual function score and proportion of women who were sexually active, we used repeated measures analytic methods to control for baseline values, assigned surgery, and failure status. For PISQ-12 scores, we used repeated measures analysis of covariance; for proportion of sexually active women, we used repeated measures logistic regression analysis. To evaluate the impact of urge incontinence on sexual function, a similar analysis was performed; we added urge index at each time point as a covariate in the repeated measures models described earlier.
Three items for the PISQ-12 were evaluated individually: pain during sexual activity (dyspareunia), incontinence during sexual activities, and fear of incontinence during sexual activities. The frequencies of affirmative responses to these items were calculated at baseline and at the 3 postoperative time points. To test the significance of change for these items, baseline and 12-month data were used. The 12-month dataset was selected because we demonstrated a sustained treatment effect through 24 months, and the 12-month sample was larger. We cross tabulated the baseline and 12-month reports of each symptom and tested for differences using a test of symmetry.
The minimum important difference (MID) is the change in a questionnaire score that represents the smallest magnitude of clinically significant improvement. An anchor-based MID for the PISQ-12 has not been published. An alternative method of the determination of a MID relies on the distribution of scores within or between groups and estimates a clinically significant change with the use of a statistical parameter such as variability (ie, SD). This distribution-based MID designates a change of 0.5 SD as a “medium” effect size.
Results
Study participants were predominantly white (79.2%), middle-aged (mean age, 52.9 ± 11.0 years), and overweight (body mass index, 30.3 ± 6.7 kg/m 2 ). The mean urge index at baseline was 35 ± 22. Baseline clinical characteristics and selected postoperative outcomes through 24 months by randomized surgery are shown in Table 1 . Approximately two-thirds of the women (406 of 597 women; 68.1%) were sexually active at baseline.
| Variable | Treatment | Total (n = 597) | |
|---|---|---|---|
| Transobturator midurethral sling (n = 299) | Retropubic midurethral sling (n = 298) | ||
| Baseline | |||
| Age, y a | 53.1 ± 11.5 | 52.7 ± 10.5 | 52.9 ± 11.0 |
| Ethnic origin, n (%) | |||
| Hispanic | 38 (12.7) | 33 (11.1) | 71 (11.9) |
| Non-Hispanic white | 233 (77.9) | 240 (80.5) | 473 (79.2) |
| Other | 28 (9.4) | 25 (8.4) | 53 (8.9) |
| Body mass index, kg/m 2 a | 30.0 ± 6.5 | 30.6 ± 7.0 | 30.3 ± 6.7 |
| Socioeconomic status score a , b | 59.6 ± 22.7 | 59.2 ± 23.0 | 59.4 ± 22.8 |
| Menopausal, n (%) | 206 (69.1) | 209 (70.4) | 415 (69.7) |
| Hormone therapy: systemic, n (%) | 90 (30.2) | 81 (27.3) | 171 (28.7) |
| Abstinence, n (%) | 94 (31.5) | 96 (32.2) | 190 (31.9) |
| Severity of urge incontinence a , c | 36.5 ± 22.0 | 33.0 ± 22.0 | 34.8 ± 22.1 |
| Prolapse/Urinary Incontinence Sexual Questionnaire score a | 32.6 ± 7.1 | 33.0 ± 7.1 | 32.8 ± 7.1 |
| INTRAOPERATIVE AND POSTOPERATIVE OUTCOME | |||
| Trocar perforation, n (%) | |||
| Bladder/urethra | 0 | 16 (5.4) | 16 (2.7) |
| Vaginal | 13 (4.3) | 6 (2.0) | 19 (3.2) |
| Voiding dysfunction, n (%) | |||
| Managed with surgery | 0 | 8 (3.3) | 8 (1.6) |
| Managed with catheter reinsertion | 7 (2.8) | 13 (5.4) | 20 (4.1) |
| Managed with medication/other | 1 (0.4) | 1 (0.4) | 2 (0.4) |
| Mesh exposure adverse event, n (%) | 8 (2.7) | 13 (4.4) | 21 (3.5) |
| Reoperation, n (%) d | 80 (26.8) | 66 (22.1) | 146 (24.5) |
| Overall surgical failure, n (%) | 165 (61.1) | 139 (53.9) | 304 (57.6) |
| Any neurologic adverse event, n (%) | 29 (9.7) | 16 (5.4) | 45 (7.5) |
a Data are given as mean ± SD;
b Nam-Powers-Boyd Occupational Status Score (range, 1–100);
c Medical, Epidemiologic, and Social Aspects of Aging Project Urge Index;
d Indications for reoperation included mesh erosion or exposure, voiding dysfunction, and retreatment of stress incontinence.
Significant and similar improvements in sexual function over time were seen in both MUS groups; the mean PISQ-12 scores of the combined study population increased from 32.8 ± 7.1 at baseline to 37.6 ± 5.5 and 37.3 ± 6.0 at 6 months and 24 months, respectively ( P < .0001). These changes are >0.6 SD units, which reflects “medium” improvement in the PISQ-12 score after surgery. Repeated measures analysis of variance of PISQ-12 scores after surgery, when controlled for baseline PISQ-12 score, found the improvement in sexual function was sustained over time with no differences identified between assigned type of surgery ( P = .44; Figure 1 ). There was, however, a significant association between PISQ score and failure status. Compared with women with successful surgery, women who experienced surgical failure, regardless of assigned type of surgery, reported worse adjusted sexual function scores at all postoperative time points ( P = .009; Table 2 ). Neither concomitant surgery nor baseline stage of prolapse was associated with postsurgery PISQ-12 scores.
| Adjusted mean PISQ-12 Score a (±SE) | ||||
|---|---|---|---|---|
| Months | Retropubic midurethral sling | Transobturator midurethral sling | ||
| Success | Failure | Success | Failure | |
| 6 | 37.4 (0.44) | 36.7 (0.74) | 37.4 (0.44) | 36.3 (0.67) |
| 12 | 37.0 (0.46) | 36.0 (0.57) | 37.3 (0.47) | 36.4 (0.58) |
| 24 | 36.9 (0.54) | 35.9 (0.51) | 37.3 (0.54) | 36.9 (0.52) |
a Controlled for baseline PISQ-12 score, concomitant surgery, and baseline stage of prolapse.
The proportion of women who were sexually active after surgery was 67.2% at 6 months and 64.1% at 24 months. The data in Table 3 and Figure 2 show greater detail of the counts and percentages of women who were sexually active in the preceding 6 months by assigned type of surgery. The proportion of sexually active women did not differ significantly from baseline ( P = .69) and did not vary significantly over the 2 years after surgery ( P = .31). Sexual activity was not associated significantly with treatment assignment ( P = .58), failure status ( P = .26), concomitant surgery ( P = .19), or baseline stage of prolapse ( P = .06). Neither intraoperative nor postoperative complications were associated significantly with sexual activity or function. When sexual activity was analyzed with “last observation carried forward” in women who completed the baseline PISQ-12 but were found to have missing data at subsequent time points, the results were unchanged.
| Variable | Total | Reported sexual activity in the preceding 6 mo after surgery a | |||||
|---|---|---|---|---|---|---|---|
| At 6 mo | At 12 mo | At 24 mo | |||||
| No | Yes | No | Yes | No | Yes | ||
| Baseline, n | |||||||
| No | 190 | 146 | 24 | 150 | 20 | 129 | 21 |
| Yes | 406 | 27 | 330 | 29 | 326 | 38 | 279 |
| Complete cases b | |||||||
| Sexually active, % | 68.1 | 67.2 | 65.9 | 64.2 | |||
| Sexual activity by treatment group, % | |||||||
| Retropubic midurethral sling | 67.8 | 67.3 | 67.0 | 67.0 | |||
| Transobturator midurethral sling | 68.5 | 67.0 | 65.0 | 61.4 | |||
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