Joel Slutsky

The Adjustable Continence Therapy System for Recurrent Female Stress Urinary Incontinence: 1-Year Results of the North America Clinical Study Group

PURPOSE We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence. MATERIALS AND METHODS Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events. RESULTS A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate. CONCLUSIONS The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

Endometriosis of the Ureter can Present as Renal Failure: A Case Report and Review of Endometriosis Affecting the Ureters

Of the female subjects with pelvic endometriosis 1.2 per cent are found to have involvement of the genitourinary tract. Ureteral obstruction secondary to endometriosis is uncommon and usually is unilateral. We report a case of renal failure with hypertension due to bilateral ureteral obstruction from pelvic endometriosis. Ureteral endometriosis and its treatment are discussed. In premenopausal women presenting with bilateral obstruction of the distal ureters endometriosis should be part of the differential diagnosis.

Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™

This paper presents 4‐year follow‐up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post‐prostatectomy stress urinary incontinence (SUI).

Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT™ pivotal trial

This paper presents 18‐month follow‐up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The trial evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post‐prostatectomy stress urinary incontinence (SUI).