Michael K. Flynn

Outcome of a Randomized, Double-Blind, Placebo Controlled Trial of Botulinum A Toxin for Refractory Overactive Bladder

PURPOSE We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder. MATERIALS AND METHODS Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies. RESULTS A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant). CONCLUSIONS Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring self-catheterization.

Comparison of 2 Techniques to Predict Voiding Efficiency After Inpatient Urogynecologic Surgery

PURPOSE We compared 2 techniques used to assess adequate postoperative bladder emptying. MATERIALS AND METHODS We performed a prospective, randomized, crossover study of 2 voiding trial techniques. 1) For back fill the bladder is filled with 300 cc saline before the Foley catheter is removed. 2) For auto fill the catheter is removed and the bladder is allowed to fill spontaneously. Patients were randomized into 2 groups for voiding trials, including group 1-auto fill followed by back fill or group 2-back fill followed by auto fill. Within 15 minutes of each void we measured post-void residual urine by straight catheterization. A void of two-thirds or greater of total bladder volume (voided volume plus post-void residual urine) at void 2 of the 2 voids was considered successful voiding. Patients who voided successfully were discharged home without a urethral catheter. We used the chi-square test with κ to determine successful bladder emptying. RESULTS We recruited 79 patients, of whom 65 with a mean age of 59.7 years (range 33 to 81) had complete data sets available for analysis. Of the patients 38 (58%) underwent prolapse repair only, 1 (2%) underwent a continence procedure only and 26 (40%) underwent each procedure. The back fill void trial correlated better with a successful voiding trial than the auto fill trial (κ = 0.91, 95% CI 0.81-1.00 vs κ = 0.56, 95% CI 0.39-0.74). Overall 40.5% of patients had an unsuccessful void trial on day 1 postoperatively and were discharged home with a catheter. None subsequently experienced urinary retention. CONCLUSIONS The back fill technique appears to be a better predictor of adequate postoperative bladder emptying than the auto fill technique for inpatient void trials.

Delayed presentation and successful repair of a recurrent vesicovaginal fistula after hysterectomy and primary abdominal repair.

Urogenital fistulae are an uncommon consequence of gynecologic surgery. Vesicovaginal fistulae due to gynecologic surgery generally appear 1–6 weeks after surgery and recurrent fistulae within 3 months of their repair. The pathogenesis of vesicovaginal fistula formation remains unclear. We present the case of a 36-year-old woman with a spontaneously recurring vesicovaginal fistula 21 months after abdominal repair of a vesicovaginal fistula caused by a laparoscopic-assisted vaginal hysterectomy. During the repair of the fistula and excision of the vaginal cuff, two small fluid-filled cysts between the bladder mucosa and the vaginal epithelium were encountered. Vesicovaginal fistulae can occur spontaneously and remote from surgery. The finding of small fluid-filled cysts in the cuff suggests that rupture of a similar cyst may have led to the formation of the fistula.

Urinary incontinence secondary to severe labial agglutination.

The purpose of the study was to describe the presentation and management of urinary incontinence because of severe labial adhesions. Records of all patients diagnosed with labial agglutination and urinary incontinence at the Division of Gynecologic Specialties between January 1999 and February 2006 were reviewed. Clinical presentation, management, and treatment outcome were extracted from the records. Five subjects were identified. Mean age was 78 (range 59–87) years. Four subjects presented with mixed and one with urge urinary incontinence. Four reported change in flow of stream with voiding. Physical examination showed near-total occlusion of the introitus and urethral meatus in four subjects and partial occlusion in one subject. All were treated topically with estrogen and/or steroids. None of the subjects improved with conservative management, and all required lysis of the labial adhesions. Postoperatively, all were treated with daily topical estrogen and three with concurrent topical steroids. All subjects reported resolution of voiding dysfunction; three had complete resolution of their incontinence. Lysis of labial adhesions combined with postoperative topical estrogen and steroids appears to be an effective treatment in women with this condition.

Patient-focused websites related to stress urinary incontinence and pelvic organ prolapse: a DISCERN quality analysis

Introduction and hypothesisThe quality of information related to pelvic floor disorders is varied and understudied. Using a validated instrument we evaluated the quality of selected websites addressing treatment options for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).MethodsEnglish-language, patient-focused professional, governmental, and consumer websites related to POP and SUI were identified using the International Urogynecology Association (IUGA) list of continence societies worldwide, search terms, and provider nomination. Websites were evaluated by 10 providers at an academic medical center, representing urogynecology (6), urology (3), and general gynecology (1). Quality assessment utilized the DISCERN instrument, a validated instrument consisting of 16 questions addressing the quality of consumer health information.ResultsWebsites of 13 organizations met inclusion criteria and were assessed, 12 relating to SUI and 8 to POP. The websites with the highest mean total DISCERN score for POP were those of the IUGA, the American Society of Colon and Rectal Surgeons, and the American Urogynecologic Association, and for SUI, the National Association For Continence, the American Urological Association, and the IUGA. High correlations were obtained for the total DISCERN score and the overall quality scores for POP (0.76) and SUI (0.82). The most commonly omitted components of the DISCERN instrument were a clear statement of the content objectives, references or sources of the content, and a discussion of what patients could expect if they opted for no intervention.ConclusionsAvailable English-language professional websites written to inform patients about management choices for SUI and POP miss key components of quality patient information.

Urinary Retention After Hysterectomy and Postoperative Analgesic Use

Objective This study aimed to determine risk factors, including postoperative analgesic use, for the development of postoperative urinary retention (PUR) after hysterectomy for routine gynecologic indications using a case-control study design. Methods Cases of PUR after hysterectomy were identified from billing data. Cases were those patients requiring recatheterization for inability to void. Controls were similarly identified and matched by age and date of surgery in a 3:1 control-to-case ratio. Chart review was performed to obtain demographic, medical, surgical, anesthetic, and medication data. Cumulative and interval doses of postoperative narcotic were recorded and converted into morphine equivalents. Crude odds ratios (ORs) were determined for potential risk factors for PUR using standard statistical analysis. Conditional logistic regression was used on multivariate models, including cumulative postoperative narcotic use, to determine adjusted ORs for risk factors. Results Twenty-six cases of PUR were matched with 78 controls. The cases had a higher body mass index (32 vs 28 kg/m2, P = 0.02), had a higher preoperative use of tricyclic antidepressants (TCA; 19.2% vs 1.3%, P = 0.004), were more likely to present preoperative urinary retention associated with fibroids (19.2% vs 0%, P < 0.01), and received a higher cumulative narcotic dose in the postoperative period (109 vs 73.6 mg, P < 0.001). In a multivariate model, preoperative TCA use (OR, 30.1; 95% confidence interval, 1.99–456; P = 0.01) and cumulative narcotic dose (OR, 2.54; 95% confidence interval, 1.44–4.56; P < 0.01) were significantly associated with PUR. Conclusions Postoperative urinary retention after hysterectomy is associated with higher postoperative narcotic dose, preoperative TCA use, and preoperative urinary retention.

Pharmacological Agents to Decrease New Episodes of Recurrent Lower Urinary Tract Infections in Postmenopausal Women. A Systematic Review.

Objectives The purpose of this systematic review was to evaluate and summarize pharmacological interventions evaluated in randomized clinical trials designed to prevent recurrent episodes of urinary tract infections (UTIs) in postmenopausal women. Methods Excerpta Medica dataBASE, Pubmed, Medline, and Cochrane Library were accessed to search for nonexperimental drugs evaluated in randomized clinical trials published in peer reviewed journals from January 1, 1970, to August 1, 2015, to reduce the number of recurrent UTIs in postmenopausal women. Results A systematic search yielded 9 articles that met eligibility criteria. Five articles involved the use of systemic or vaginal estrogen therapy and the remainder used oral antibiotics, lactobacilli, or a combination of interventions. Antibiotics were the most efficacious therapy but with a higher incidence of systemic side effects. Oral lactobacillus was noninferior to sulfamethoxazole with trimethoprim with a safer profile in 1 small study. Vaginal estrogen appeared to be inferior to continuous oral antibiotic suppression; however, use of multiple formulations of both treatment options precludes meta-analysis. Oral estrogen use did not decrease UTI recurrence and resulted in local and systemic side effects in up to nearly 30% of the patients. Conclusions This review supports the use of antibiotic suppression, vaginal estrogen, and oral lactobacillus for prevention of recurrent UTIs in postmenopausal women. However, the overall dearth of data suggests that this is an important but understudied population. Because the effectiveness and safety of available treatments are not well understood, they should be used with caution in older populations, pending further study.

Cost-utility of routine endometrial evaluation before le fort colpocleisis

Introduction Routine preoperative evaluation of the endometrium before Le Fort colpocleisis is often recommended. There are no data, however, to support this practice. In select patients, it may not be a necessary addition to the preoperative evaluation of Le Fort colpocleisis. Methods A decision analysis model was created to compare uterine evaluation, by either endometrial (EM) biopsy or transvaginal ultrasound, to no evaluation for a hypothetical cohort of women undergoing Le Fort colpocleisis. We assumed the absence of risk factors for EM cancer. Probabilities and health outcome utilities were obtained from literature review. Medicare charges were used to estimate cost in 2012 US dollars. Cost-utility analysis was performed using US recommendations from a health plan perspective. Results At willingness-to-pay thresholds of

Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial.

50,000 and

Inherited pelvic organ prolapse in the mouse: preliminary evaluation of a new murine model

100,000, no evaluation is superior to both biopsy and ultrasound. At a 64% probability of cancer, biopsy is more cost-effective than no evaluation and ultrasound. Conclusions Compared to biopsy and ultrasound, in low-risk women, no EM evaluation before Le Fort colpocleisis demonstrates superior cost-utility.