Treatment Trials

7 Clinical Trials for Various Conditions

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COMPLETED
Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
Description

The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. The investigators theorize that the sling helps with primary hypermobility of this pathophysiologic cause of stress urinary incontinence.

WITHDRAWN
Male Stress Urinary Incontinence and Sexual Health
Description

The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.

Conditions
COMPLETED
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Description

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

COMPLETED
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Description

To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.

COMPLETED
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
Description

The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence. The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.

TERMINATED
Virtue® Male Sling Fixation Study
Description

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

COMPLETED
Virtue® Male Incontinence Sling Study
Description

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.