Treatment of moderate to severe female stress urinary incontinence with the adjustable continence therapy (ACT) device after failed surgical repair.

INTRODUCTION: Treatment of recurrent stress incontinence after a failed surgical procedure is more complicated, and repeat surgeries have higher rates of complications and limited efficacy. We determined the technical feasibility, efficacy, adjustability, and safety of adjustable continence therapy device for treatment of moderate to severe recurrent urinary incontinence after failed surgical procedure. MATERIALS AND METHODS: Female patients with moderate to severe recurrent stress urinary incontinence who had at least one prior surgical procedure for incontinence were enrolled. All patients underwent percutaneous placement of adjustable continence therapy (ACT) device (Uromedica, Plymouth, Minnesota). Baseline and regular follow-up tests to determine subjective and objective improvement were performed. RESULTS: A total of 89 patients have undergone implantation with 1-3 years of follow-up. Data are available on 77 patients at 1 year. Of the patients, 47% were dry at 1 year and 92% improved after 1-year follow-up. Stamey score improved from 2.25 to 0.94 at 1 year (P < 0.001). IQOL questionnaire scores improved from 33.9 to 71.6 at 1 year (P < 0.001). UDI scores reduced from 60.7 to 33.3 (P < 0.001) at 1 year. IIQ scores reduced from 57.0 to 21.6 (P < 0.001) at 1 year. Diary incontinence episodes per day improved from 8.1 to 3.9 (P < 0.001) at 1 year. Diary pads used per day improved from 4.3 to 1.9 (P < 0.001). Explantation was required in 21.7% of patients. CONCLUSION: The ACT device is an effective, simple, safe, and minimally invasive treatment for moderate to severe recurrent female stress urinary incontinence after failed surgical treatment.

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.

Occult spinal dysraphism and urolithiasis: are patients at higher risk of stone disease?

BACKGROUND AND PURPOSE: Spinal dysraphism is associated with urinary-tract dysfunction in severe cases such as meningomyelocele, in part because of incomplete innervation of the lower urinary tract. Patients with meningomyelocele are at higher risk for stone formation, possibly secondary to stasis of urine from aberrant storage and emptying. However, minimal data exist on the risk of stone formation in patients with milder forms of spinal dysraphism. The purpose of this study was to examine whether an association exists between urolithiasis and occult spinal dysraphism (OSD). PATIENTS AND METHODS: All patients who underwent a non-contrast CT scan of the abdomen and pelvis during a 4-month period were included. The final dataset consisted of 374 consecutive patients (195 men, 179 women) with a mean age of 54.2 years (range 18-95 years). Scans were reviewed for evidence of urolithiasis and, independently, for skeletal abnormalities. Patients with urolithiasis included those with a kidney, ureteral, or bladder stone(s). Patients with OSD included those with bifid lumbosacral bony elements, posterior arch defects, or incomplete fusion or non-fusion of S1, S2, or S3. The association between urolithiasis and OSD was examined by calculating series of crude and adjusted odds ratios (ORs) with corresponding 95% confidence intervals (CIs). RESULTS: Of the 374 patients, 135 (36.1%) had urinary calculi, and 83 (22.2%) had OSD. No relation was found between the prevalence of OSD and stone disease (OR 1.22; 95% CI 0.72, 2.08), even after adjusting for potential confounders. CONCLUSION: Unlike severe spinal dysraphism, OSD does not appear to confer an increased risk of stone disease.

MR imaging evaluation of the pelvic floor for the assessment of vaginal prolapse and urinary incontinence.

Pelvic MR imaging using the combination of motion-insensitive T2-weighted single-shot fast spin echo and high soft tissue resolution standard T2-weighted fast spin echo techniques has helped to identify soft tissue abnormalities that directly correlate with the clinical and intraoperative findings related to pelvic floor prolapse. In particular, the authors have shown that pelvic MR imaging has the ability to identify changes related to uterosacral ligament disruption and to document the corrective changes after surgical repair of this ligament. In the future, pelvic MR imaging is expected to play a progressively larger role in preoperative planning for complex or uncertain cases and for more detailed evaluation of repair in cases that do not show good symptomatic response. Pelvic MR imaging should also help to document and advance knowledge of surgical repair methodology.

Complete transvaginal surgical management of multiple bladder calculi and obstructed uterine procidentia.

BACKGROUND: Bladder calculi are rare in women and are associated with irreducible pelvic organ prolapse. We report a case of irreducible uterine procidentia and bladder calculi that was surgically managed with a complete transvaginal approach. CASE: A 76-year-old woman presented with irreducible complete uterine procidentia. Bladder stones were appreciated on examination and confirmed with imaging. The patient was managed surgically with transvaginal cystolithotomy, uterus-sparing Lefort colpocleisis, and perineorrhaphy under spinal anesthesia. The patient had an uncomplicated postoperative course without recurrent prolapse or urinary retention at 3-month follow-up. CONCLUSION: The presence of bladder calculi should be considered in the setting of irreducible pelvic organ prolapse. A complete transvaginal approach with cystolithotomy and concomitant obliterative procedure without hysterectomy is a safe and effective alternative to the traditional approach.