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ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males

NCT00277095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2018-05-31

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

ProACT (Adjustable Continence Therapy)

Implantable device to reduce urinary stress incontinence

Sponsors & Collaborators

  • Uromedica

    lead INDUSTRY

Principal Investigators

  • Tim Cook, Ph.D · Uromedica, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-02-28
Completion
2017-12-31

Countries

  • United States
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277095 on ClinicalTrials.gov