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Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

NCT00113555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2018-07-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which 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 the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

Conditions

Interventions

DEVICE

ACT (Adjustable Continence Therapy)

surgically implanted device

Sponsors & Collaborators

  • Uromedica

    lead INDUSTRY

Principal Investigators

  • Tim Cook · Uromedica, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2008-07-31
Completion
2010-11-30

Countries

  • United States
  • Canada

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 NCT00113555 on ClinicalTrials.gov