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.

AimsEvaluate the Altis single‐incision sling for treatment of female stress urinary incontinence through 24 months.MethodsThis was a prospective, multi‐center, industry‐sponsored (Coloplast Corp.), single‐arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6‐months. Device‐ and procedure‐related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory‐Short Form, Incontinence Impact Questionnaire‐Short Form, and Patient Global Impression of Improvement.ResultsOf the 113 women implanted, 94 remained at 24‐months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow‐up data at 24‐months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P‐value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P‐value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported “very much better” or “much better” on the Patient Global Impression of Improvement. No new device‐ or procedure‐related adverse events occurred between the 12 and 24 month visits.ConclusionsThe Altis single‐incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress‐predominant mixed urinary 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

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence Therapy II1 Apr 2014MP38-06 TRANSURETHRAL RADIOFREQUENCY COLLAGEN DENATURATION IN THE TREATMENT OF MILD TO MODERATE FEMALE STRESS URINARY INCONTINENCE: TWELVE-MONTH INTERIM ANALYSIS James Lukban, Peter Takacs, Monisha Crisell, Douglas Van Drie, Denise Elser, Phillip Bressman, Royce Adkins, and Randall Kahan James LukbanJames Lukban More articles by this author , Peter TakacsPeter Takacs More articles by this author , Monisha CrisellMonisha Crisell More articles by this author , Douglas Van DrieDouglas Van Drie More articles by this author , Denise ElserDenise Elser More articles by this author , Phillip BressmanPhillip Bressman More articles by this author , Royce AdkinsRoyce Adkins More articles by this author , and Randall KahanRandall Kahan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1263AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Women with anatomic stress urinary incontinence may also have a measure of bladder neck funneling, with ultrasound confirmation of its presence found to be associated with a lower maximal urethral closure pressure, a smaller area under the urethral pressure profile curve, a lower leak point pressure, and a larger volume of leakage on pad testing. Radiofrequency (RF) collagen denaturation has been found to reduce tissue compliance, with a potential role in reducing bladder neck funneling in patients with stress urinary incontinence (SUI). We sought to determine the efficacy of RF employing the Lyrette device (Verathon Inc., Bothell, Washington, USA) in women with mild to moderate SUI. METHODS This is an on-going, prospective, 36-month, open-label, multi-center clinical study enrolling women with anatomic SUI and urodynamic indices of Valsalva Leak-point Pressure (VLPP) > or = 90 cm H2O and Maximum Urethral Closure Pressure (MUCP) > or = 45 cm H2O. Intervention was in the form of transurethral RF energy delivered to the bladder neck and proximal urethra at 65 degrees C° to a total of 36 foci. Primary endpoint was the percentage of patients deemed to be “dry” at 12 months as defined by < or = 1 leak on 3-day diary or < or = 1 gram of leak on 1-hour pad weight test (PWT). Secondary endpoints included the proportion of patients with a > or = 50% decrease on PWT; cough stress test (CST); quality of life (QoL) measures including the Incontinence Quality of Life (I-QoL) Questionnaire and the Urogenital distress Inventory (UDI-6); immediate post-treatment pain as per a ten-point Visual Analog Scale (VAS) (1 minimum –10 maximum); and patient satisfaction. RESULTS Fifty-two patients underwent treatment and had follow-up through 12 months. Subjects were analyzed by Intent-to-Treat. Dry rate was 82%; 73% had a > or = 50% decrease on PWT; and 71% exhibited a negative CST. Seventy-nine percent and 80% showed an improvement in I-QoL and UDI-6 scores, respectively. Statistically significant improvement was seen in both QoL scales as compared to baseline. No significant post-treatment pain was recorded, with a mean VAS score of 1.7 + 1.8. Seventy-four percent were “very” or “somewhat”satisfied and 88% would “…refer this treatment to a friend…”. No serious adverse events were recorded. CONCLUSIONS At 12 months, treatment of women with mild to moderate SUI employing Lyrette yielded favorable efficacy, improvement in QoL and high patient satisfaction. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e402-e403 Advertisement Copyright & Permissions© 2014Metrics Author Information James Lukban More articles by this author Peter Takacs More articles by this author Monisha Crisell More articles by this author Douglas Van Drie More articles by this author Denise Elser More articles by this author Phillip Bressman More articles by this author Royce Adkins More articles by this author Randall Kahan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Purpose: We describe the safety and efficacy of the Altis (R) Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months.Materials and Methods: In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events.Results: Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months.Conclusions: The Altis sling appears to be safe and efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months.

Study Objective: To report Mini Arc single-incision sling efficacy results in the office setting and the feasibility of performing the procedure in the office.Design: Prospective, single-arm, nonrandomized, institutional review board approved study (Canadian Task Force classification II-2).Setting: Three in-office clinical sites in the United States.Patients: Thirty-eight patients who underwent treatment of stress urinary incontinence using the MiniArc single-incision sling.Intervention: A MiniArc single-incision sling was placed in 38 patients in an office-based setting under intravenous or oral sedation and/or local anesthesia.Measurements and Main Results: Thirty-eight implant recipients were evaluated for effectiveness and safety via qualitative (Urinary Distress Inventory Short Form [UDI-6] and Incontinence Impact Questionnaire Short Form [IIQ-7]) and quantitative (1-hour pad-weight test and cough stress test) measurements at 3 clinical sites. Secondary outcome measures included procedure time, estimated blood loss, length of stay, perioperative complications, Wong-Baker Faces Pain Scale, and adverse events. During the study, 38 women (mean [SD; 95% CI] age, 48.1(8.4; 45.3-50.8 years)) received slings. Mean procedure time was 10.6 minutes, estimated blood loss was 23.2 mL, and length of stay was 1.3 hours. At discharge, the Wong-Baker pain score was 0.2 (0.0-2.0). At 2 years, 31 patients were available for follow-up. Of these, 93.5% had normal findings on the cough stress test, and 90.3% had pad weight <1 g; and 90.6% and 87.5%, respectively, using last failure carried forward analysis in 32 patients. The UDI-6 and IIQ-7 median scores showed a statistically significant decrease from baseline (p < .001). There were no reports of serious adverse events or of bowel, urethral, bladder, or major vessel perforation.Conclusion: The in-office experience suggests that implantation of a single-incision sling for treatment of stress urinary incontinence with the patient under intravenous or oral sedation and/or local anesthesia can be performed safely, with effective results. Thus, performing this procedure in an office setting is a viable option. Journal of Minimally Invasive Gynecology (2012) 19, 331-338 (C) 2012 AAGL. All rights reserved.

OBJECTIVE: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh.STUDY DESIGN: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage >= III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change.RESULTS: Anatomic success, defined as prolapse stage <= I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.0-84.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be "much better." Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year.CONCLUSION: These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns.