Bladder instillations versus onabotulinumtoxinA injection for interstitial cystitis/bladder pain syndrome: A randomized clinical trial.

BACKGROUND: Interstitial cystitis/bladder pain syndrome is an unpleasant sensation related to the bladder with lower urinary tract symptoms lasting more than six weeks, unrelated to an otherwise identifiable cause. The etiology is likely multifactorial including urothelial abnormalities, neurogenic pain upregulation, and potentially bladder and vaginal microbiome alterations. Despite treatment effectiveness of both bladder instillations and intradetrusor onabotulinumtoxinA injection for this condition, a head-to-head comparison has not been performed. OBJECTIVES: To compare the efficacy of bladder instillations and intradetrusor onabotulinumtoxinA injection for treatment of interstitial cystitis/bladder pain syndrome. STUDY DESIGN: Patients with O'Leary-Sant (OLS) questionnaire scores of ≥ 6, meeting clinical criteria for interstitial cystitis/bladder pain syndrome, and desiring procedural management were randomized to bladder instillations or intradetrusor onabotulinumtoxinA injection. The primary outcome was the difference in OLS scores at 2 months post-treatment between groups. Secondary outcomes included evaluation of sexual function, physical/mental health status, pain, patient satisfaction, treatment perception, retreatment, and adverse event rates. RESULTS: 47 patients were analyzed with 22 randomized to bladder instillations and 25 to onabotulinumtoxinA injection. There were no differences in demographic and clinical characteristics between groups. From baseline to 2 months post-treatment, there was a decrease in OLS subscales in all patients (Interstitial Cystitis Symptom Index (ICSI) -6.3 (CI -8.54, -3.95), p<.0001; Interstitial Cystitis Problem Index (ICPI) -5.9 (CI -8.18, -3.57), p<.0001). At 2 months post-treatment, patients in the onabotulinumtoxinA group had significantly lower OLS scores compared to those in the bladder instillation group (ICSI 6.3 ± 4.5 [onabotulinumtoxinA] versus 9.6 ± 4.2 [instillation], p=.008; ICPI 5.9 ± 5.1 [onabotulinumtoxinA] versus 8.3 ± 4.0 [instillation], p=.048). The difference in OLS scores between groups did not persist at 6-9 months post-treatment. There were no statistically significant differences between baseline and post-treatment time points for the remaining questionnaires. Eight percent of patients who received onabotulinumtoxinA injection experienced urinary retention requiring self-catheterization. Patients who underwent onabotulinumtoxinA injection were significantly less likely to receive retreatment within 6-9 months compared to patients who received bladder instillations (relative risk 13.6; 95% CI, 1.92-96.6; P=.0002). There were no differences between groups regarding patient satisfaction, perception of treatment convenience, or willingness to undergo retreatment. CONCLUSIONS: Both onabotulinumtoxinA injection and bladder instillations are safe, effective treatments for patients with interstitial cystitis/bladder pain syndrome, with significant clinical improvement demonstrated at 2 months post-treatment. Our findings suggest that intradetrusor onabotulinumtoxinA injection is a more effective procedural treatment for this condition than bladder instillation therapy and associated with decreased rates of retreatment.

More With Less: Single-Incision Sling Insertion Techniques.

STUDY OBJECTIVE: To demonstrate reproducible procedures for efficient single-incision sling insertion and troubleshooting. DESIGN: Narrated video footage with stepwise demonstration of single-incision sling insertion technique with anchor system. SETTING: The mesh midurethral sling is a highly effective and safe procedure that is considered the gold standard for surgical treatment of stress urinary incontinence. Retropubic and transobturator approaches for midurethral slings have similar subjective cure rates with differing surgical risk profiles [1,2]. The retropubic route has a higher risk of injury to the bladder, nerves, and vascular structures, whereas the obturator approach carries a risk of groin or thigh pain [3-5]. Use of a single-incision sling decreases these risks and allows flexibility to perform the procedure without sedation or general anesthesia. Recent literature demonstrates similar subjective and objective success and safety of single-incision slings compared with both retropubic and transobturator approaches, although long-term data are forthcoming [5]. INTERVENTIONS: We demonstrate a stepwise approach for the insertion of a single-incision sling using a helical trocar. Easily reproducible procedures for setup and sling anchor management allow for efficient placement without assistance. In addition, we outline hand positioning, trocar management, and anchor deployment with troubleshooting techniques for potential placement difficulties. Finally, we review methods for sling tensioning to prevent complications such as voiding dysfunction and mesh or suture exposures. CONCLUSION: Given that single-incision slings are more likely to be performed under local anesthesia and are less invasive with decreased recovery time, it has the potential to become the preferred approach in the future. This video demonstrates clear and detailed steps to facilitate successful placement of the single-incision mesh midurethral sling.

Colpocleisis Techniques: An Open-and-shut Case for Advanced Pelvic Organ Prolapse.

OBJECTIVE: To highlight several advanced surgical techniques for all types of colpocleisis. Pelvic organ prolapse is a common condition that affects up to 40% of the postmenopausal female population.1,2 Particularly for women with advanced pelvic organ prolapse who no longer desire penetrative vaginal intercourse and with multiple medical comorbidities, the obliterative approach is preferred due to decreased anesthetic needs, operative time, and perioperative morbidity.3 Additionally, colpocleisis is associated with a greater than 95% long-term efficacy with low patient regret, high satisfaction, and improved body image.4,5 MATERIALS AND METHODS: The umbrella term of "colpocleisis" encompasses a uterine-sparing procedure, the LeFort colpocleisis, colpocleisis with hysterectomy, and posthysterectomy vaginal vault colpocleisis. We demonstrate the surgical steps of performing each type of colpocleisis as well as levator myorrhaphy and perineorrhaphy, which are typically included to reinforce the repair. RESULTS: To streamline the LeFort colpocleisis procedure, we demonstrate use of electrosurgery to mark out the epithelium and methods to create the lateral tunnels with LeFort colpocleisis with and without the use of a urinary catheter. We also present techniques that can be utilized across all types of colpocleisis including the push-spread technique for dissection, tissue retraction with Allis clamps and rubber bands on hemostat clamps to improve visualization, and approximation of the anterior and posterior vaginal muscularis to close existing space. Attention must be paid not to proceed past the level of the urethrovesical junction to avoid angulation of the urethra. We use an anatomic model to demonstrate appropriate suture placement during levator myorrhaphy to facilitate an adequate purchase of the levator ani muscles in order to adequately narrow the vaginal opening. Ultimately the goal of the colpocleisis procedure is a well-approximated, obliterated vagina, approximately 3 cm in depth and 1 cm in width. CONCLUSION: The skills demonstrated enable the surgeon to maximize efficiency and surgical outcomes for an effective obliterative procedure for advanced stage pelvic organ prolapse.

Prevalence of Pelvic Floor Disorders in United States Active-Duty Service Women Seeking Medical Care.

IMPORTANCE: In the United States, pelvic floor disorders affect 25% of women. Despite facing unique occupational risk factors that may increase the risk of pelvic floor disorders, there is little research on the prevalence of these disorders in active-duty service women. OBJECTIVES: This study sought to identify the prevalence of and risk factors for pelvic floor disorders in active-duty service women in the United States from diagnostic codes through service utilization. STUDY DESIGN: Utilizing the Military Health System Data Repository, a cross-sectional study was conducted of all active-duty service women in the United States Army, Air Force, Navy, and Marine Corps during fiscal years 2010 to 2019. RESULTS: This study identified 497,255 active-duty service women of whom 9.93% had pelvic floor disorders. Adjusted regression model analyses indicated increasing parity and body mass index significantly affect the risk of pelvic floor disorders. Active-duty women with 3 or more births were 3 times more likely to have pelvic floor disorders compared with the nulliparous group. Finally, subset analysis indicates the risk of pelvic floor disorders were increased 250% in obese women and decreased 20% for underweight women. The rate of pelvic floor disorders appears to be increasing among active-duty women. CONCLUSIONS: Active-duty service women have significantly lower rates of pelvic floor disorders compared with the general population, possibly due to the protective effects of improved weight management and physical fitness requirements for their job performance. However, pelvic floor disorders may be uptrending and need continued monitoring.

Effects of Preoperative Gabapentin on Clinical Outcomes After Outpatient Midurethral Sling Placement.

OBJECTIVES: This study aimed to evaluate transient urinary retention in women undergoing outpatient midurethral sling placement who received preoperative gabapentin (treated) versus those who did not (untreated). Secondary outcomes included unexpected admission rates, analgesic usage, time to discharge, and pain. METHODS: This was a retrospective cohort study including women who underwent outpatient midurethral sling placement from 2015 to 2019. Exclusion criteria included suprapubic catheter placement, planned overnight admission, abnormal preoperative postvoid residual volume, and prolonged postoperative catheterization. Logistic regression was performed to evaluate gabapentin usage and urinary retention after adjusting for patient characteristics. RESULTS: Three hundred two women met the inclusion criteria, with 19.5% experiencing urinary retention after midurethral sling placement. Women older than 65 years were more likely to have urinary retention than those aged 18-65 years (29.8% vs 17.6%, P = 0.054). Of treated participants, 26% had urinary retention versus 18% of untreated participants (P = 0.162). Adjusting for age, parity, pain, operative time, blood loss, sling type, analgesic, scopolamine patch, or hemostatic agent use, treated participants had 72% higher odds of urinary retention (adjusted odds ratio, 1.72; 95% confidence interval, 0.88-3.38; P = 0.113). There was no difference in unexpected admission, analgesic usage, time to discharge, or pain between groups. CONCLUSIONS: One of 5 women had urinary retention after outpatient midurethral sling placement. Although no statistically significant difference was found in urinary retention between groups, the odds of urinary retention in the treated group were increased. Because there was no difference in pain, analgesic usage, or time to discharge between groups, investigation regarding gabapentin use for outpatient urogynecologic surgery is needed.

Does symptom severity predict response to low-dose onabotulinumtoxinA for the treatment of urgency urinary incontinence?

OBJECTIVE: Intradetrusor onabotulinumtoxinA is a third-line treatment for urgency urinary incontinence (UUI) which is customarily reserved for severe disease. We sought to determine if symptom severity predicts the proportional response to onabotulinumtoxinA and whether low-dose injection may be an appropriate treatment for mild-moderate symptoms. STUDY DESIGN: This prospective cohort study compared patients with urgency urinary incontinence who were recruited from the Urogynecology Clinic with mild-moderate (2-9 episodes/3-day diary) and severe UUI (>9 episodes/3-day diary) symptoms. Twenty-eight subjects were treated (11 mild-moderate, 17 severe) with 50 units of intradetrusor onabotulinumtoxinA. Voiding diaries and validated questionnaires (UDI-6 and IIQ-7) were collected at baseline and one, six, and twelve months post-treatment. The primary outcome was the difference in percent reduction in UUI episodes per 3-day diary at one month. Secondary outcomes included differences in absolute reduction of UUI events, treatment success rate (defined as greater than 50% reduction in UUI episodes), changes in UDI-6 and IIQ-7 questionnaire scores, and rates of urinary retention, self-catheterization, and urinary tract infection. Normally distributed data are presented as means with standard deviations (SD) and groups were compared using the two sample t-test. Data that were not normally distributed are presented as medians with the interquartile range (IQR) and were compared using the Wilcoxon rank sum test. RESULTS: The mild-moderate group showed median improvement; 100% (IQR: 100%, 100%) and severe group; 81% (IQR: 35%, 100%), p < 0.019. Both had significant improvement in UUI episodes; the mild-moderate group decreased by four and the severe group by 15. No differences were noted in percent reduction between groups. There was no association between baseline severity and percent reduction in UUI episodes (rs = 0.127, p = 0.544); however, absolute reduction was highly correlated (rs = -0.821, p < 0.001). Treatment success was 90% in mild-moderate and 73% in the severe group (p = 0.615). Complications included urinary tract infections (25%) and intermittent catheterization (3.6%). CONCLUSIONS: Patients with both mild-moderate and severe symptoms showed a statistically significant improvement in UUI events from baseline to one month, but no difference between the groups in proportional improvement or treatment success.