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Early Activation of Artificial Urinary Sphincter

NCT03962569 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2019-08-09

No results posted yet for this study

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.

Conditions

  • Incontinence, Urinary

Sponsors & Collaborators

  • CAMC Health System

    lead OTHER

Principal Investigators

  • joshua lohri, DO · CAMC Health System

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • United States

Study Locations

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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 NCT03962569 on ClinicalTrials.gov