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NCT05456308 · ClinicalTrials.gov registry record · NA

What is the Optimal Technique for Hydrodistention?

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
96
Enrollment target

NCT05456308: Completed NA study, sponsored by University of Michigan.

NCT05456308 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05456308, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
96 participants
Enrollment target

Study 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).

Primary Outcome

Identify the optimal technique for hydrodistention, including the optimal pressure (30 vs 80cc), number of hydrodistentions (one vs two), duration of each hydrodistention (one vs two minutes) as quantified by Changes in the interstitial cystitis symptom index (ICSI)f rom baseline to 1-month. The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score

Interventions

  • PROCEDURE Hydrodistention during cystoscope

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2022-07-01
Est. Completion 2024-03-31
Phase NA
University of Michigan

1,327 total trials

What the finished NCT05456308 record still lists

NCT05456308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Hydrodistention during cystoscope is the first listed.

NCT05456308 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05456308 about?

NCT05456308 is a clinical study titled "What is the Optimal Technique for Hydrodistention?". 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 ...

What is the current status of trial NCT05456308?

This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2022-07-01. Estimated completion is 2024-03-31.

What interventions are being tested in trial NCT05456308?

The interventions under investigation include: Hydrodistention during cystoscope (PROCEDURE).

Who is sponsoring clinical trial NCT05456308?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05456308's enrollment target sits among peer trials

96 925th of 2000 higher than 1,070 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05456308, the US trial registry maintained by the National Library of Medicine. NCT05456308 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.