Tristi W. Muir

A vaginal bowel-control system for the treatment of fecal incontinence.

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms “very much better” or “much better.” There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P⩽.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73–95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01655498. LEVEL OF EVIDENCE: II

Laparoscopic cervicoisthmic cerclage: Technique and systematic review of the literature

Background and Aims: To report on and review the outcome after laparoscopic cervicoisthmic cerclage (LCC) and robotic-assisted laparoscopic cervicoisthmic cerclage. Methods: We reported on 4 cases of LCC and conducted a systematic review of the literature up to May 2012 to identify obstetric outcomes after LCC and robotic-assisted LCC. Results: The median age of our series was 35 years (range: 31–41) with median previous pregnancies 3.5 (2–5). All 4 women had successful obstetric outcomes with a median gestational age at delivery of 37 weeks (range: 36–38). The systematic review identified 25 studies (162 women underwent LCC and 3 had robotic-assisted LCC). In the interval LLC studies, the median age was 33 years (range: 22–42); with a median gestational age at delivery of 37 weeks (range: 34–38). For prophylactic LCC, the median age was 31 years (range: 27–41); with a gestational age at delivery of 37 weeks (range: 19–39). Two of the three robotic-assisted LCC procedures were done prophylactically. The median age was 27 years (range: 23–37) with a median gestational age at delivery of 37 weeks (range: 35–38). Conclusion: LCC is feasible during and in between pregnancies as well as in congenitally malformed uteri. Current evidence suggests that LCC might be of benefit in selected cases of cervical insufficiency with short cervices.

Impact of a Novel Vaginal Bowel Control System on Bowel Function

BACKGROUND: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence. OBJECTIVE: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation. DESIGN: This was a secondary analysis of a multicenter, prospective clinical trial. SETTINGS: This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery. PATIENTS: A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included. INTERVENTIONS: The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump. MAIN OUTCOME MEASURES: Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements. RESULTS: Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034). LIMITATIONS: The study follow-up period was 1 month (with an optional additional 2 months). CONCLUSIONS: The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.

Does body mass index impact passing voiding trial after midurethral sling procedures for stress urinary incontinence

Objective: To test the hypothesis that body mass index (BMI) is a factor associated with passing a voiding trial after midurethral sling procedures for stress urinary incontinence (SUI). Study Design: The medical records of 136 consecutive patients who underwent placement of either tension-free vaginal tape (TVT) or transobturator tape (TOT) for SUI during a 1-year period (September 1, 2007 to August 31, 2008) were retrospectively reviewed. Variables assessed were BMI, age, and passing or failing a postoperative urinary voiding trial. Patients with concomitant pelvic organ prolapse surgeries were not included in this analysis. Results: Sixty-seven patients underwent TVT, whereas 69 had TOT procedures. In the TVT group, 30 patients (42%) were unable to void immediately postoperatively compared with 11 patients (16%) in the TOT group (P = 0.0003). The mean (SD) age and BMI of patients who failed or passed voiding trials was 58.6 (12.0) years and 28.0 (4.9) kg/m2 or 53.5 (12.3) years and 29.8 (5.7) kg/m2, respectively. Of 38 patients who did not pass a voiding trial on the day of the procedure, 31 (82%) passed on postoperative day 1, and all patients had passed a voiding trial by postoperative day 11. The mean (SD) BMI for 7 patients who did not pass voiding trial by postoperative day 1 was 28.3 (5.2) kg/m2. Conclusions: Women with higher BMIs were more likely to pass voiding trials after midurethral sling procedures. Patients who had TOT placement had greater success passing a postprocedure voiding trial than did patients who had TVT placement.

Hemorrhagic complication during placement of tension-free vaginal tape

A 66-year-old para III with a 20-year history of stress urinary incontinence underwent placement of tension-free vaginal tape. Intraoperative arterial bleeding occurred. An expanding hematoma was palpated postoperatively. Interventional radiology performed a pelvic arteriogram with selective bilateral internal iliac arteriograms, a supraselective anterior division and obturator arteriogram, a left external iliac arteriogram, coil embolization of a branch of the left obturator artery, and gel foam embolization of the anterior division of the left internal iliac artery.

Characteristics Associated with Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence

Objectives We previously showed that management with a novel vaginal bowel control system was efficacious in women with moderate to severe fecal incontinence. The objective of this secondary analysis was to evaluate the clinical characteristics associated with device-fitting success. Methods This is a secondary analysis of an institutional review board-approved, multicenter, prospective, open-label clinical study of women aged 19 to 75 years with 4 or more episodes of fecal incontinence recorded on a 2-week baseline bowel diary. Those successfully fitted with the vaginal bowel control device entered a 1-month treatment period, and efficacy was assessed with a repeat bowel diary. Demographic data, medical and surgical history, and pelvic examination findings were compared across women with successful and unsuccessful completion of the fitting period. Multivariate logistic regression analysis was performed. Results Six clinical sites in the United States recruited from August 2012 through October 2013. Overall, 110 women underwent attempted fitting, of which 61 (55.5%) of 110 were successful and entered the treatment portion of the study. Multivariate logistic regression analysis revealed that previous prolapse surgery (P = 0.007) and shorter vaginal length (P = 0.041) were independently associated with unsuccessful fitting. Women who have not undergone previous prolapse surgery had 4.7 times the odds (95% confidence interval [CI], 1.53-14.53) of a successful fit. In addition, for every additional centimeter of vaginal length, women had 1.49 times the odds (95% CI, 1.02-2.17) of a successful fit. Conclusions Shorter vaginal length and previous prolapse surgery were associated with an increased risk of fitting failure. These findings may be used to inform patients regarding their expectation of successful fitting.