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COMPLETED
NCT03962569

Early Activation of Artificial Urinary Sphincter

Sponsor: CAMC Health System

View on ClinicalTrials.gov

Summary

Urinary incontinence or loss of bladder control is a troublesome issue for all affected patients. The causes of urinary incontinence and its treatment options vary widely. A commonly encountered reason for urinary incontinence in men is related to treatment for prostate cancer. These treatment options can range from surgical removal of the prostate, external beam radiation therapy, and/or brachytherapy, the insertion of radioactive implants directly into the tissue. Mild cases of incontinence are responsive to more conservative measures, but moderate to severe cases often require placement of an artificial urinary sphincter. Typically, these devices are left deactivated for a period of 4- 6 weeks following implantation to allow swelling to subside before use. The investigators hypothesize that the device could be activated within an earlier timeframe without increasing the risk of complications. No studies to date have evaluated this; therefore the investigators plan to conduct a prospective study in which the investigators will activate the device 3 weeks after placement and monitor for complications.

Official title: Early Activation of Artificial Urinary Sphincter: A Pilot Study

Key Details

Gender

MALE

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2019-08-01

Completion Date

2024-01-08

Last Updated

2026-08-21

Healthy Volunteers

Yes

Locations (1)

Charleston Area Medical Center

Charleston, West Virginia, United States