A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence.

STUDY OBJECTIVE: The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. DESIGN: Postmarket, prospective, multicenter, nonrandomized cohort design. SETTING: The study was performed at 23 hospitals in the United States and Canada. PATIENTS: Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). INTERVENTIONS: Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling. MEASUREMENTS AND MAIN RESULTS: Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. CONCLUSION: At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Complications of ethylene vinyl alcohol copolymer as an intraurethral bulking agent in men with stress urinary incontinence.

OBJECTIVES: To report the short-term safety and efficacy of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Inc., Covington, GA) in the off-label treatment of male stress urinary incontinence. METHODS: We reviewed the charts of all adult male patients who received EVA copolymer between 2005 and 2006 for demographics, physical examination findings, urodynamic findings, outcomes, and complications. RESULTS: A total of 17 of 18 men completed follow-up after receiving EVA during this time period. With an average of 1.4 injection sessions, 58.8% of patients experienced a complication related to the procedure, with 41.1% of these complications being urethral erosion of the material and 22% experiencing severe pain on injection. Subjective improvement of at least 50% was reported by 41.1% of patients. The mean follow-up period was 4.2 months. CONCLUSIONS: Intraurethral bulking agents are meant to be a minimally invasive procedure with lower complication rates than alternatives such as the artificial urinary sphincter and male sling. The off-label use of EVA in men in this case series resulted in a significant complication rate. Urethral erosion was the most common complication causing dysuria, precluding further bulking in others, and resulting in loss of benefit with passage of material. In addition, EVA used in men may be less efficacious than the Food and Drug Administration data reported in women, especially with prior injectable therapy. In December 2006, EVA was voluntarily taken off the marketplace by CR Bard owing to reports from clinicians.

The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency.

The purpose of this post-marketing case-series is to report the short-term safety and effectiveness of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Covington, GA, USA) in the treatment of intrinsic sphincter deficiency (ISD). The charts of all female patients who received ethylene vinyl alcohol (EVA) copolymer between 2005 and 2006 were reviewed for demographics, physical exam, urodynamic findings, outcomes and complications. Nineteen of twenty women who received EVA during this period completed follow-up. After an average of 1.4 injections, approximately 58% of the patients had a complication related to the procedure with 37% experiencing urethral erosion. Of the patients, 10.5% reported at least a 50% subjective improvement in their symptoms. Intra-urethral bulking for the treatment of SID is meant to be minimally invasive and safe with minimal reports of complications. This series of 19 patients show significant percentage of patients experiencing serious complications with Tegress. Additionally, Tegress may be less efficacious than reported in the FDA trials, especially those with prior injections. A long-term prospective study needs to be performed in women with ISD before treatment can be recommended for general use by all gynecologists and urologists.

Transvaginal urethrolysis for obstruction after antiincontinence surgery.

Our objective was to determine our success in relieving bladder outlet obstruction (BOO) with a transvaginal urethrolysis (TVU). This was a chart review that included 55 patients who underwent 61 TVU procedures between 2001 and 2005. Twenty-three patients had at least one prior TVU. Outcomes evaluated included obstructive symptoms, need for catheterization, postvoid residual (PVR), irritative symptoms, and stress urinary incontinence (SUI). Of the 46 patients with obstructive voiding preoperatively, 87% were cured. Of the 47 patients with irritative symptoms, 45% were cured, 34% improved, and 21% were left unchanged. SUI, generally mild, was noted postoperatively in 16% patients. Similar success was seen among patients with prior procedures. Aggressive TVU is very successful in relieving urinary retention and improving or curing overactive bladder symptomatology due to iatrogenic obstruction, even when a prior urethrolysis had been unsuccessful. SUI is an infrequent complication.

Current trends in the evaluation and management of female urinary incontinence.

Despite its common occurrence and often seemingly obvious causes, female urinary incontinence requires a thorough and thoughtful evaluation for its proper diagnosis and treatment. With rare exceptions, urinary incontinence is the result of failure of the sphincter mechanism to resist bladder pressures encountered during daily activities. This may be the result of sphincter failure, overactivity of the bladder detrusor muscle or both. In uncomplicated cases, the diagnosis is usually based on an evaluation in the office. Urodynamic and cystoscopic study may be helpful in complex, resistant and recurring cases of urinary incontinence of any cause. Most cases of incontinence may be classified as stress, urge or mixed urinary incontinence. Treatment of stress urinary incontinence focuses on supplementing the urethral continence mechanisms, particularly the urethral supports and periurethral striated muscle function. The current paradigm for the treatment of urge incontinence centres on pharmacologic therapy, primarily by correcting detrusor overactivity with antimuscarinic drugs. Other therapies aimed at altering sensorimotor function may be used in resistant cases. The treatment of mixed urinary incontinence requires consideration of the contribution of each of its components. With proper diagnosis, effective treatment is possible for most patients.