CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
Behavioral Therapy +3 morebehavioral
Likely dose
Pelvic Floor Electrical Stimulation daily for 8 weeksAI-extracted
Key inclusion· 2
  • Involuntary urine loss that started immediately after radical prostatectomy and persisted for at least one year
  • One-week bladder diary with interpretable data documenting at least two incontinence episodes
Key exclusion· 7
  • Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
  • Cardiac pacemaker or implanted cardiac defibrillator
  • Current use of anticholinergic agents for detrusor instability
  • Folstein's Mini-Mental State Exam score below 24 (impaired mental status)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00212264
NCT00212264N/ACompleted

Conservative Treatment of Postprostatectomy Incontinence

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Sep 21, 2005·Updated Apr 11, 2016

In Brief

A clinical study evaluating Behavioral Therapy, Pelvic Floor Electrical Stimulation, and 2 other interventions for Urinary Incontinence. Completed, enrolled 208 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartAug 1, 2003
Primary CompletionSep 1, 2008
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Behavioral Therapybehavioral

Pelvic Floor Muscle Exercises and Bladder control strategies

Pelvic Floor Electrical Stimulationdevice

Pelvic Floor Electrical Stimulation daily for 8 weeks

Biofeedbackbehavioral

Pelvic Floor Muscle training via biofeedback

No Treatmentother

No treatment