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Supervised Exercise for Interstitial Cystitis (IC/BPS Trial)
N/A
Recruiting
Led By Stephen J Walker, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult females (>18 years and <80 years) with a previously established clinical diagnosis of Interstitial cystitis/bladder pain syndrome (IC/BPS) will be eligible to participate
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 3, week 6
Awards & highlights
IC/BPS Trial Summary
This trial will explore if exercise can reduce symptoms and improve quality of life for people with interstitial cystitis/bladder pain syndrome.
Who is the study for?
This trial is for English-speaking adult women aged 18-80 with a diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), confirmed by a specialist. Participants must be able to walk without assistance and tolerate moderate exercise, not pregnant, and free from certain conditions like bladder cancer or neurological disorders.Check my eligibility
What is being tested?
The study tests whether a supervised exercise regimen can alleviate symptoms of IC/BPS and improve the quality of life in patients. It explores the effectiveness of physical activity as part of treatment for this chronic bladder condition.See study design
What are the potential side effects?
While specific side effects are not listed for an exercise regimen, participants may experience typical exercise-related discomforts such as muscle soreness or fatigue. Any significant health risks will likely be assessed by physicians before clearance to participate.
IC/BPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18-79 with diagnosed interstitial cystitis/bladder pain.
IC/BPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 3, week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 3, week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interstitial Cystitis Problem (ICPI) Index Scores
Interstitial Cystitis Symptom Index (ICSI) Scores
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
Secondary outcome measures
Change in the Short Form 36 (SF-36) Health Survey Scores
Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores
Other outcome measures
Changes in inflammatory urinary biomarkers
Post-regimen review
IC/BPS Trial Design
1Treatment groups
Experimental Treatment
Group I: Exercise treatment groupExperimental Treatment1 Intervention
This group will serve as both their own controls and study subjects for the experimental intervention. They will take surveys to record bladder symptoms and quality of life before undergoing exercise. They will then take the same surveys after exercise and their scores will be compared.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise regimen
2004
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
UNC GreensboroUNKNOWN
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,257 Total Patients Enrolled
6 Trials studying Interstitial Cystitis
252 Patients Enrolled for Interstitial Cystitis
University of North Carolina, GreensboroOTHER
31 Previous Clinical Trials
16,631 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do moderate exercise and have been active for 90 minutes a week.I can walk without any help from devices like canes or wheelchairs.I have a history of specific cancers or conditions affecting my bladder or nervous system, or I am currently experiencing an active genital herpes episode.I am a woman aged 18-79 with diagnosed interstitial cystitis/bladder pain.I have been diagnosed with bladder pain syndrome as per the American Urological Association Guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise treatment group
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.
Can I be enrolled in this research study?
"This clinical trial is allowing 15 patients in total and they must have interstitial cystitis as well as be between 18 to 80 years old."
Answered by AI
Is the eligibility criterion for this clinical trial restricted to persons below 85 years of age?
"According to the parameters of this research, participants aged between 18 and 80 are eligible for inclusion. Separately, there exist 378 clinical trials geared towards minors and 997 studies targeting seniors over 65 years old."
Answered by AI
Is there still availability in this research endeavor for participants?
"As evidenced on clinicaltrials.gov, this research project is no longer taking in new recruits; the original posting was February 1st 2023 and it has been revised lastly on January 25th 2023. Nevertheless, 1418 other trials are still open for enrollment presently."
Answered by AI
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