Longitudinal Reoperation Risk After Apical Prolapse Procedures in Women Aged 65 Years and Older.

OBJECTIVE: To describe longitudinal reoperation risk among older women undergoing surgery for apical pelvic organ prolapse (POP) and to compare risk of reoperation for prolapse and complications among different surgical approaches. METHODS: This nationwide, retrospective cohort study evaluated older adult women (aged 65 years and older) within the Centers for Medicare & Medicaid Services' (CMS) 5% LDS (Limited Data Set) who underwent sacrocolpopexy, uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), or colpocleisis, or their uterine-preserving equivalents, from January 1, 2011, to December 31, 2018, with follow-up through 2019. The primary outcome was overall reoperation, and secondary outcomes included reoperation for POP and for complications. Rates were compared using χ 2 tests for categorical variables, Wilcoxon rank-sum for continuous variables and Kaplan Meier estimates of cumulative incidence. Death and exit from CMS insurance were considered as censoring events. We used cumulative incidence to calculate reoperation risk as a function of time at 1 year or more, 3 years or more, and 7 years or more. RESULTS: This cohort included 4,089 women who underwent surgery to treat apical POP from 2011 to 2018: 1,034 underwent sacrocolpopexy, 717 underwent USLS, 1,529 underwent SSLF, and 809 underwent colpocleisis. Demographics varied among patients for each POP surgery. Patients who underwent the different surgeries had differences in age ( P <.01), Charlson Comorbidity Index score ( P <.01), diabetes ( P <.01), chronic obstructive pulmonary disease ( P <.01), hypertension ( P <.01), chronic pain ( P =.01), congestive heart failure ( P <.01), and concomitant hysterectomy ( P <.01). Reoperation rates were low and increased over time. The overall reoperation risk through 7 years was 7.3% for colpocleisis, 10.4% for USLS, 12.5% for sacrocolpopexy, and 15.0% for SSLF ( P <.01). Reoperation for recurrent POP through 7 years was 2.9% for colpocleisis, 7.3% for sacrocolpopexy, 7.7% for USLS, and 9.9% for SSLF ( P <.01). Reoperation for complications through 7 years was 5.3% for colpocleisis, 8.2% for sacrocolpopexy, 6.4% for USLS, and 8.2% for SSLF ( P <.01). CONCLUSION: The type of surgical repair is significantly associated with long-term risk of reoperation. Colpocleisis offers the least likelihood of reoperation for prolapse, followed by sacrocolpopexy; colpocleisis followed by USLS has the least risk of long-term reoperation for complication.

Use of a Computerized Decisional Analysis Tool in Patients With Urgency Urinary Incontinence.

IMPORTANCE: Decision analysis tools (DAT) are shared decision making instruments that include patient input on treatment goals and values that have been shown to decrease decisional regret in women's health care. OBJECTIVE: We describe a novel, computerized DAT for patients with urinary incontinence (UI), and our primary aim was to assess the concordance between treatment fit as determined by the DAT and treatment selected after physician counseling in patients with urgency urinary incontinence and urgency predominant mixed urinary incontinence. STUDY DESIGN: We partnered with a health care startup to develop a computerized DAT incorporating evidence about UI and patient input about treatment goals and personal values. This is a retrospective cohort study examining the concordance of DAT-predicted treatments identified before consultation with the physician and those chosen after counseling. Electronic medical records were reviewed to abstract demographic, clinical data, and treatments chosen at the initial physician consultation. Because it was possible to pursue concurrent treatment options (ie, pelvic floor physical therapy and medications), the first 2 modalities identified in the treatment plan at consultation were abstracted. Descriptive statistics were conducted using SPSS®, we did not adjust for multiple comparisons. RESULTS: Four hundred eighty-nine patients met the inclusion criteria for our study, and 65% of the cohort chose treatment options after counseling that were concordant with their DAT best treatment fit. CONCLUSION: Patients choosing treatment for urgency urinary incontinence and urgency predominant mixed urinary incontinence using a novel, computer-based DAT to prepare for shared decision making with their physicians often choose to proceed with their top DAT-determined treatment fit after counseling.

Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether retropubic midurethral sling combined with onabotulinumtoxinA is more effective than sling alone in improving mixed urinary incontinence symptoms. METHODS: We conducted a prospective, double-blind, randomized, controlled trial of women with mixed urinary incontinence, planning to undergo midurethral sling. Women were randomly assigned to receive 100 unites of intradetrusor onabotulinumtoxinA or placebo during surgery. Participants completed the PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7) before and 3 months after surgery, and the primary outcome, PGI-I (Patient Global Impression of Improvement), 3 months postoperatively. Primary outcome was PGI-I score at 3 months for overall incontinence. We considered women "improved" with answers of "very much better" or "much better" on the PGI-I. Assuming a PGI-I response of "improved" in 66% of placebo and 93% of onabotulinumtoxinA participants, 68 women were needed to show a significant difference with 80% power at 0.05 significance level. RESULTS: From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41; placebo: 37). Mean age was 51 years (±10). On the PGI-I, the number who "improved" did not differ between groups at 3 months (83% vs 84%, P=1.0). The onabotulinumtoxinA group had less severe urgency symptoms as indicated by median urgency PGI-S scores (1 [interquartile range 1-2] vs 2 [interquartile range 1-3], P=.033) and greater improvement in urgency symptoms based on median urgency PGI-I score (1 [interquartile range 1-3] vs 2 [interquartile range 2-4], P=.028). At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups. Similarly, UDI-6 and PFIQ-7 scores did not differ between groups. More women in the onabotulinumtoxinA arm initiated intermittent self-catheterization, (3% placebo; 12% onabotulinumtoxinA, P=.20) and experienced urinary tract infections (5% placebo; 22% onabotulinumtoxinA, P=.051), but these did not differ statistically. CONCLUSION: Concurrent intradetrusor onabotulinumtoxinA injection did not improve overall incontinence symptoms at 3 months compared with placebo among women with mixed urinary incontinence undergoing midurethral sling placement. Women with mixed urinary incontinence undergoing sling report significant improvement in overall incontinence symptoms, regardless of the addition of onabotulinumtoxinA injections, but those receiving concurrent onabotulinumtoxinA injections reported less urgency severity and greater improvement in urgency symptoms at 3 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02678377.