Early Activation of Artificial Urinary Sphincter
Status unconfirmed
Conditions studied: Incontinence, Urinary
In brief
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.
Key facts
- Study ID
- NCT03962569
- Run by
- CAMC Health System
- People needed
- 25
- Starts
- 2019-08-01
- Expected to finish
- 2023-04-30
- Last updated by the study team
- 2019-08-09
Who can join
Age: 18 and older, up to 99. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- All patients undergoing artificial urinary sphincter (AUS) placement by single surgeon, Joshua Lohri, DO.
You may not qualify if…
- Any patient who has previously undergone artificial urinary sphincter placement and presents for revision or additional cuff placement.
- Any patient who is undergoing combined artificial urinary sphincter and inflatable penile prosthesis placement.
- Any patient who is a poor candidate for early activation due to poor condition at presentation or signs of infection.
Where it is running
- Charleston Area Medical Center — Charleston, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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