Two-year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence.

AIMS: Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months. METHODS: This 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. RESULTS: Of 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. CONCLUSIONS: The 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.

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.

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.

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.

The safety and efficacy of a new adjustable single incision sling for female stress urinary incontinence.

PURPOSE: We describe the safety and efficacy of the Altis(®) 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.

MiniArc single-incision sling in the office setting.

STUDY OBJECTIVE: To report MiniArc 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.

Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study.

AIMS: An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding. PATIENTS & METHODS: Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle). Safety was assessed by the incidence of treatment-emergent adverse events, ophthalmologic examinations and ECGs, among other evaluations. RESULTS: The most commonly reported treatment-emergent adverse events were menstrual discomfort (46.2%), headache (43.9%) and back pain (23.1%). A small proportion of participants (3.8%) reported ocular adverse events, but there was no evidence of ocular toxicity. No prothrombotic effects were observed. CONCLUSION: During nine menstrual cycles of treatment, this novel formulation of TA was well tolerated and exhibited a favorable safety profile supporting its use as a therapy for cyclic heavy menstrual bleeding.

Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes.

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.