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Conservative Treatment of Postprostatectomy Incontinence

NCT00212264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2016-04-11

Study results available
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Summary

The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

Conditions

Interventions

BEHAVIORAL

Behavioral Therapy

Pelvic Floor Muscle Exercises and Bladder control strategies

DEVICE

Pelvic Floor Electrical Stimulation

Pelvic Floor Electrical Stimulation daily for 8 weeks

BEHAVIORAL

Biofeedback

Pelvic Floor Muscle training via biofeedback

OTHER

No Treatment

No treatment

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Patricia S Goode, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-09-30
Completion
2011-08-31

Countries

  • United States

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 NCT00212264 on ClinicalTrials.gov