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Procedure

Hydrodistention Techniques for Interstitial Cystitis

N/A
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with IC/BPS who have failed first/second line treatments (behavioral therapy, medications) for greater than 3 months
Have not had hydrodistention performed in the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3-months
Awards & highlights

Study Summary

This trial is testing different ways of performing hydrodistention to see which is best for patients with IC/BPS.

Who is the study for?
This trial is for individuals with Interstitial cystitis/bladder pain syndrome (IC/BPS) who haven't improved after trying behavioral therapy and medications for over three months. They shouldn't have had hydrodistention, botox, or PTNS in the last three months and must not have certain bladder conditions, UTIs, a history of pelvic cancers or surgeries, neurological disorders like dementia or Parkinson's disease, neurogenic bladder issues, anuria (no urine output), tuberculosis in the bladder, cyclophosphamide treatment or be pregnant.Check my eligibility
What is being tested?
The study is testing different ways to perform hydrodistention during a cystoscopy procedure on patients with IC/BPS. It aims to determine if variations in pressure applied during distention, number of times it's done and how long each lasts make any difference to symptom improvement over a follow-up period of three months.See study design
What are the potential side effects?
While specific side effects are not listed here for this procedure-based intervention trial; generally speaking hydrodistention may cause temporary discomforts such as increased urinary frequency/urgency/pain post-procedure which usually resolve within few days.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have IC/BPS and treatments for over 3 months haven't worked.
Select...
I have not undergone bladder stretching in the last 3 months.
Select...
I haven't had botox or PTNS in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interstitial Cystitis
Secondary outcome measures
Changes in the genitourinary pain index (GUPI) baseline to 3-months
Changes in the genitourinary pain index (GUPI) from baseline to 1- month
Changes in the genitourinary pain index (GUPI) from baseline to 1-week
+5 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Pressure (80 centimeters), Duration (2 minute), Number of times done (2)Experimental Treatment1 Intervention
Group II: Pressure (80 centimeters), Duration (2 minute), Number of times done (1)Experimental Treatment1 Intervention
Group III: Pressure (80 centimeters), Duration (1 minute), Number of times done (2)Experimental Treatment1 Intervention
Group IV: Pressure (80 centimeters), Duration (1 minute), Number of times done (1)Experimental Treatment1 Intervention
Group V: Pressure (30 centimeters), Duration (2 minute), Number of times done (2)Experimental Treatment1 Intervention
Group VI: Pressure (30 centimeters), Duration (2 minute), Number of times done (1)Experimental Treatment1 Intervention
Group VII: Pressure (30 centimeters), Duration (1 minute), Number of times done (2)Experimental Treatment1 Intervention
Group VIII: Pressure (30 centimeters), Duration (1 minute), Number of times done (1)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,782 Previous Clinical Trials
6,364,561 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
240 Patients Enrolled for Interstitial Cystitis

Media Library

Hydrodistention during cystoscope (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05456308 — N/A
Interstitial Cystitis Research Study Groups: Pressure (30 centimeters), Duration (1 minute), Number of times done (1), Pressure (30 centimeters), Duration (2 minute), Number of times done (1), Pressure (30 centimeters), Duration (1 minute), Number of times done (2), Pressure (80 centimeters), Duration (1 minute), Number of times done (1), Pressure (80 centimeters), Duration (2 minute), Number of times done (1), Pressure (80 centimeters), Duration (1 minute), Number of times done (2), Pressure (30 centimeters), Duration (2 minute), Number of times done (2), Pressure (80 centimeters), Duration (2 minute), Number of times done (2)
Interstitial Cystitis Clinical Trial 2023: Hydrodistention during cystoscope Highlights & Side Effects. Trial Name: NCT05456308 — N/A
Hydrodistention during cystoscope (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456308 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this clinical experiment?

"Although this medical trial was posted on July 1st 2022 and last updated on the 8th, clinicaltrials.gov indicates that it is not actively searching for participants at present. However, there are currently 37 other studies recruiting patients across the country."

Answered by AI
~18 spots leftby Sep 2024