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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-months
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving or have received cyclophosphamide treatment.You have signs of a urinary tract infection in a urine test.I have been diagnosed with tuberculosis in my bladder.I have a spinal cord injury.I'm sorry, but it seems like the phrase "interstim" is incomplete. Can you provide more context or clarify what "interstim" refers to?I have a history of neurological conditions like dementia or Parkinson's.I have had issues with my urethra or received pelvic radiation.I am unable to produce urine.I have had bladder enlargement or removal surgery.People with a condition that affects the nerves controlling the bladder.I have IC/BPS and treatments for over 3 months haven't worked.I have a history of cancer in my urinary or reproductive organs.I have not undergone bladder stretching in the last 3 months.I haven't had botox or PTNS in the last 3 months.I have been diagnosed with Hunner's lesions.
Research Study Groups:
This trial has the following groups:- Group 1: Pressure (30 centimeters), Duration (1 minute), Number of times done (1)
- Group 2: Pressure (30 centimeters), Duration (2 minute), Number of times done (1)
- Group 3: Pressure (30 centimeters), Duration (1 minute), Number of times done (2)
- Group 4: Pressure (80 centimeters), Duration (1 minute), Number of times done (1)
- Group 5: Pressure (80 centimeters), Duration (2 minute), Number of times done (1)
- Group 6: Pressure (80 centimeters), Duration (1 minute), Number of times done (2)
- Group 7: Pressure (30 centimeters), Duration (2 minute), Number of times done (2)
- Group 8: Pressure (80 centimeters), Duration (2 minute), Number of times done (2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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