Simone Crivellaro

Adjustable Continence Therapy for the treatment of male stress urinary incontinence : A single-centre study

Objective. To evaluate the Adjustable Continence Therapy (ProACT™) device, a new device for the treatment of male stress urinary incontinence resulting from compromised sphincteric function. Material and methods. A total of 64 males with post-prostatectomy incontinence underwent ProACT implantation. Efficacy was assessed by means of a daily pad count, a direct visual stress test, administration of the Incontinence Quality of Life (IQOL) and patient global impression (PGI) questionnaires and use of a visual analogue scale (VAS) to assess improvement in incontinence. These assessments were performed at baseline, 1, 3, 6 and 12 months after the procedure and annually thereafter. Results. The pad count declined from a median of 5.2 at baseline to 2 at 6 months and to 1.54 at 12 months. The median baseline IQOL score was 31.7, and this improved to 62.5 at 6 months and to 71.1 at 12 months. In terms of postoperative daily pad usage, 43 patients (67%) were considered to be dry, 10 (15%) improved and 11 (17%) unchanged. In terms of the post operative PGI score, 42 patients (66%) considered themselves to have improved greatly, 10 (16%) to have improved quite a lot, 6 (9%) to have improved slightly and 6 (9%) to be unchanged. The average improvement based on the VAS was 80%. The average number of postoperative adjustments was three (range zero to nine). Complications included infection (2/64; 3%), erosion of balloons (5/64; 7.6%), migration (2/64; 3%) and balloon deflation (2/64; 3%). Device removal was required in 9/64 patients (14%) but was easily achieved using local anaesthesia, and this thus permitted further therapeutic intervention. New balloons were implanted following endoscopic confirmation of urethral healing. Conclusion. The ProACT device represents an efficacious treatment modality, which has an acceptable complication rate for a difficult group of patients.

Adjustable continence therapy for treatment of recurrent female urinary incontinence.

PURPOSE The Adjustable Continence Therapy (ACT) device has been developed for the treatment of recurrent stress urinary incontinence resulting from intrinsic sphincter deficiency (ISD) by increasing urethral coaptation. We critically evaluated the technique and its results. METHODS The ACT device consists of two balloons each attached to an injectable port placed in the labia majora. The port enables postoperative adjustment in balloon coaptation pressure. All 49 patients had previously failed anti-incontinence surgery. Each patient was implanted with the ACT device and assessed by preoperative and postoperative overall impression, incontinence quality of life questionnaire, and visual analog scale; 38 of the 49 subjects had a minimum of 1 year of data collected, including pad use, number of adjustments needed, and complications. RESULTS Mean operative time was 20.3 minutes (range 10-30 minutes), with 88% of implantations performed using local or regional anesthesia. Balloon adjustments were needed in 62%; 68% of patients reported being dry and 16% improved. Complications included migration (12%), balloon failure (3.6%), and erosion (4%). CONCLUSION The ACT device provided significant improvement in at last 70% of patients with recurrent stress urinary incontinence.

Adjustable continence therapy (ProACT) and bone anchored male sling: Comparison of two new treatments of post prostatectomy incontinence.

Objectives:  To compare the efficacy of two surgical treatments for male urinary stress incontinence: adjustable continence therapy (ProACT) and bone anchored male sling (BAMS).

Adjustable Continence Therapy for Severe Intrinsic Sphincter Deficiency and Recurrent Female Stress Urinary Incontinence: Long-Term Experience

PURPOSE ACT was developed to treat female stress urinary incontinence resulting from intrinsic sphincter deficiency by increasing urethral resistance. We evaluated the implantation procedure and assessed patient outcomes at our center. MATERIALS AND METHODS The adjustable continence device consists of 2 silicone balloons on either side of the proximal urethra under the bladder neck, each attached to a titanium port buried in the labia to allow postoperative titration. Urodynamic assessment was done in 57 female patients in whom previous pelvic surgery had failed. Pad use and an incontinence quality of life questionnaire were evaluated before ACT implantation, postoperatively at 1, 3, 6 and 12 months, and annually thereafter. Patients recorded the overall impression and percent of improvement postoperatively based on the Patient Global Impression Index and a visual analog scale. RESULTS Mean followup was 72 months (range 12 to 84). At 6-year followup in 29 patients mean pad use improved from 5.6 daily at baseline to 0.41 and intrinsic sphincter deficiency improved from 27.2 to 78.6 (p <0.001). As measured on the visual analog scale, 68% of patients considered themselves dry. On the Patient Global Impression Index questionnaire 64% were very much improved, 23% were much improved and 13% were only minimally improved or unchanged. No patients considered themselves worse after the procedure. Complications necessitating device removal developed in 21.1% of patients. CONCLUSIONS Relative ease of insertion and the ability to tailor this therapy to individual needs makes this an attractive option for the challenging treatment for recurrent stress urinary incontinence due to intrinsic sphincter deficiency.

Can MRI Predict Which Patients Are Most Likely to Benefit from Percutaneous Positioning of Volume-Adjustable Balloon Devices?

Purpose: To assess whether magnetic resonance imaging (MRI) is useful in predicting which patients affected by stress urinary incontinence (SUI) will benefit from a new anti-incontinence therapy named adjustable continence therapy (ACT™). Methods: We prospectively evaluated a group of 25 female patients affected by SUI and treated with ACT. Before and after treatment all patients were clinically assessed by physical examination, urodynamic evaluation and pad test. All patients had an MR examination before and 3 and 12 months after ACT surgery to compare the position of the bladder neck in relation to the pubococcygeal line (PCL). Results: 21/25 (84%) patients were improved; 16 (64%) of these patients were dry and 5 (20%) significantly improved. Before treatment, the mean PCL distance was significantly different (p < 0.01) between the responsive and the non-responsive groups. Conclusions: MRI provides an effective radiological method to predict the efficacy of the ACT.

Transobturator Tape in the Management of Female Stress Incontinence: Clinical Outcomes at Medium Term Follow-Up

Objective: To assess the efficacy of transobturator tape (TOT) in the management of stress urinary incontinence at a medium term follow-up. Methods: TOT is a polypropylene tape positioned through the obturator foramen. 70 patients with type II urinary stress incontinence were treated with TOT between June 2003 and May 2006. Patients were prospectively studied by physical examination, quality of life questionnaire (I-QOL), visual analog scale, global impression (dry, improved, same, worse), preoperative urodynamic study, and pre- and postoperative flowmetry. Statistical analysis (t test) of the difference in I-QOL scores and flowmetry was made by StatSoft V. 5.1. Results: The average follow-up was 32 (range 12–48) months. The I-QOL score increased statistically significantly by 40 points. The average percent improvement was 80%. 90% (63/70) of the patients were dry and 5% (4/70) were improved. The pre- and postoperative uroflowmetry studies were not statistically different. Vaginal erosion occurred in 4 patients. Conclusion: TOT is a safe procedure with a good efficacy at 32-month follow-up.

Minimally Invasive Therapies for Female Stress Urinary Incontinence: the Current Status of Bioinjectables/New Devices (Adjustable Continence Therapy, Urethral Submucosal Collagen Denaturation by Radiofrequency)

The aim of this review is to provide an update on the current status of evolving minimally invasive therapies for stress urinary incontinence. Bioinjectables have been available for some time and their current status is reviewed. The adjustable continence device has been used as a salvage procedure for females for a number of years in clinical trials, yet many are unfamiliar with it. Lastly, radiofrequency via a transurethral route has also been utilized in small numbers and will be updated. These later two emerging technologies need further exposure to better define their role in our clinical practice.

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.

Geometrical stepper-guided navigation system for ProACT implant under transrectal ultrasound control: preliminary data.

Purpose: To describe a new geometrical stepper-guided navigation system for positioning ProACT®. Methods: The sizing of the stepper-guided navigation system was calculated using the distance from the ideal position of the device to anatomic referral points previously measured by ultrasound. The trocar and subsequently the device were maneuvered to the ideal position in accordance with the navigation system. Measurements: Treatment efficacy was evaluated with daily pad count, 1-hour pad test, Incontinence Quality of Life questionnaire (IQoL), visual analog scale and overall impression. Complications, balloon volume and number of adjustments were reported at 1, 3, 6 and 12 months follow-up visits. Results: Mean follow-up was 12 (range 3–19) months. Daily pad count showed 30 patients (71%) dry and 9 patients (21%) improved. 1 hour pad test showed 28 patients were dry (66%) and 11 patients improved (26%). IQoL increased from an average of 35.3 to 80. Average visual analog scale score was 8. Complications requiring device removal occurred in 3 patients (7%). Mean balloon volume was 3.1 ml. Conclusions: The stepper-guided navigation system to implant ProACT is feasible and extremely reproducible making this procedure more standardized.

Sacral Neuromodulation for Urinary Retention in a Kidney-Transplant Patient

Bladder outlet obstruction can negatively affect renal function in the kidney transplant population. Functional obstruction represents a clinical challenge as conventional treatments are either ineffective or not recommended. Sacral neuromodulation was successfully used in functional voiding dysfunction in a kidney transplant patient. This is the first case to be reported in the literature.