John F. Bresette

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.

Mixed incontinence: does preoperative urodynamic detrusor overactivity affect postoperative quality of life after pubovaginal sling?

OBJECTIVE Our purpose was to determine if women with mixed urinary incontinence (MUI) and urodynamic detrusor overactivity (DO) have less improvement in urinary symptoms after pubovaginal sling surgery (PVS), compared to MUI without DO. MATERIALS AND METHODS Women with preoperative MUI symptoms prior to PVS were identified through retrospective review. DO was defined as a symptomatic 5 cm H20 detrusor pressure or greater rise during urodynamics. MUI patients with and without DO before PVS were divided into Groups A and B, respectively. All patients had returned a completed Urogenital Distress Inventory 6 (UDI-6) questionnaire and a 3-day diary of pad usage before surgery and at each postoperative visit. Study endpoints included change in total UDI-6 score, and change in number of pad use/day after PVS. RESULTS 73 patients were identified, 31 in Group A and 42 in Group B. Mean follow-up after PVS was 15 and 16 months, respectively (p = 0.59). Preoperative total UDI-6 scores were 11.8 and 12.7 (p = 0.30) for Group A and B. Mean changes in total UDI-6 after PVS were - 8.0 and - 10.2 (p = 0.030), respectively. After PVS, both groups reported similar mean reduction in pad/day usage from preoperative baseline (-2.57 vs. --2.49, p = 0.83). There were no differences between the groups when comparing demographic, urodynamic, or operative data. CONCLUSION MUI patients had improved continence and quality of life after PVS. However, MUI patients with DO had less improvement in UDI-6 scores after PVS, despite a similar reduction to pad use/day.

Retropubic surgery for stress urinary incontinence

More than 150 surgical techniques have been proposed in the literature for treating stress urinary incontinence. Many of the original published approaches were vaginal, but through the years the literature has expanded to include needle suspension, pubovaginal slings, and retropubic procedures. In this chapter, we focus on retropubic approaches for the treatment of SUI and discuss the physiology, indications, technical details and the complications of these procedures.

Correlation between urodynamic function and 3D Cat scan anatomy in neobladders: Does it exist?

We compared the functional and anatomical differences among three different orthotopic neobladders, utilizing video urodynamics and 3D CT to determine what parameters, if any, correlate to function.

The Use of Human Dermal Allograft Material for Transvaginal Slings

We evaluated the safety and efficacy of using human dermal allograft material for transvaginal slings to treat female stress urinary incontinence (SUI). Materials and Methods We present a prospective series of 253 patients with SUI treated with a transvaginal sling using a Repliform cadaveric human dermal allograft (LifeCell Corp., The Woodlands, Texas) and a bone anchor fixation kit. Clinical history, urogynecologic examination and videourodynamics were performed preoperatively. Results were assessed by a third party through validated quality of life questionnaires (Incontinence Impact Questionnaire and Urogenital Distress Inventory), overall impression and percent of improvement as perceived by the patients, and pad use. Scheduled follow-up examination were performed to rule out erosion, infection, obstruction, pain or recurrent incontinence. Results Complete follow-up was available on 234 of 253 patients. Average follow-up was 18 months. Of the patients 78% were cured or improved according to the questionnaires. The average improvement was 80%. At 18 months of follow-up incontinence average distress and scores decreased 10 and 7 points, respectively. Complications were de novo urgency in 5% of cases, recurrent SUI in 15% with no cases of persistent SUI, retention in 2% and slow vaginal wall healing in 1.7%. Of 156 patients 51 (22%) had persistent urgency. There were no cases of vaginal or urethral erosion, osteitis pubis or osteomyelitis. Conclusions Our data indicate that use of human dermal allograft for transvaginal slings is associated with low complication rates and favorable outcomes at an average of 18 months of follow-up.