NCT05456308

What is the Optimal Technique for Hydrodistention?

What is the Optimal Technique for Hydrodistention? First Prospective Study Evaluating the Effect of Pressure, Duration and Number of Hydrodistentions on Patients with Interstitial Cystitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to learn what is the best way to perform hydrodistention. Eligible participants will be enrolled and have follow-up for three months after surgery. The study team hypothesizes that changes in hydrodistention technique, including pressure, number of distention, and duration of distention, leads to no or minimal changes in symptom improvement for patients with Interstitial cystitis/bladder pain syndrome (IC/BPS).

Detailed description

Hydrodistention is a procedure designed to treat bladder and pelvic symptoms in patients with interstitial cystitis. A camera is placed inside the bladder and the bladder is filled with fluid. This procedure "resets" the signals between the bladder and brain, in order to reduce the symptoms of interstitial cystitis (such as bladder pain, urinary urgency/frequency/dysuria, incontinence, incomplete emptying, etc). However, it is still unknown the best way to perform hydrodistention. Doctors do not know how much fluid to put in the bladder, how long to keep the fluid in the bladder, and how many times to fill the bladder.

Conditions

• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
PROCEDURE	Hydrodistention during cystoscope	Hydrodistention for treatment of interstitial cystitis will be performed. Participants will be randomly selected to one of the arms described. There are three variables that they will be assigned: the pressure of fluid in the bladder that will be filled, the duration of time that the fluid will be held in the bladder, and the number of times the procedure is completed.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2022-07-13
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States