An interventional study of Exercise regimen in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
In this study, the efficacy of exercise to improve interstitial cystitis/bladder pain syndrome symptoms and quality of life will be investigated.
Effective treatment for symptoms associated with interstitial cystitis/bladder pain syndrome is a significant clinical challenge due to the lack of insight into disease etiology/pathophysiology, costly and potentially invasive procedures, and a lack of research into potential therapeutics. The primary objective of this study is to determine if a supervised exercise program by a trained exercise physiologist can relieve pain and improve urinary and bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. This has the potential to open enormous future avenues of research, save both patients and the healthcare system cost, and most importantly improve patients' lives. A second objective of this study is to determine if exercise alters depressive symptoms, often a comorbid diagnosis, in patients with interstitial cystitis/bladder pain syndrome. A third objective of this study is to examine urinary markers of inflammation before and after exercise in patients with interstitial cystitis/bladder pain syndrome.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
Browse Cystitis, Interstitial studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Exercise regimen
Exercise will take place Monday, Wednesday, and Friday from 12:00-1:00 pm for 6 weeks. Aerobic exercise will consist of walking, beginning with a 10-minute duration, with gradual progression to 20 minutes. Muscle strength, endurance and range-of-motion exercise will then be performed. Muscle strength and endurance training will begin using no weight and performing one set of 6 repetitions. Progression using added resistance in the form of dumbbell weights (1-6 lbs.) and increased sets and repetitions will be applied as Subjects become increasingly fit. For static range of motion exercise, positions will be held for 10-15 seconds in the beginning and increased over time. Exercise will be kept at a moderate level of intensity. Each session will then end with relaxation training.
Interstitial Cystitis Symptom Index (ICSI) Scores
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Time frame: baseline
Interstitial Cystitis Problem (ICPI) Index Scores
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Time frame: week 3
Interstitial Cystitis Symptom Index (ICSI) Scores
Participants answer a series of questions to get a final score. Scores range from 0-20, with 0 being no symptoms and 20 the most severe.
Time frame: week 3
Interstitial Cystitis Problem (ICPI) Index Scores
Participants answer a series of questions to get a final score. Scores range from 0-16, with 0 being no symptoms and 16 the most severe.
Time frame: week 6
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time frame: baseline
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time frame: week 3
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
This survey is used to grade people with chronic pelvic pain. Participants answer a series of questions. Scores range between 0 and 35, and studies have indicated that a score greater than 12 is indicative of significant symptoms
Time frame: week 6
Change in the Short Form 36 (SF-36) Health Survey Scores
The SF-36 is a questionnaire that consists of 8 subsections of 36 total questions. The sections are Physical functioning (10 items), Role limitations due to physical health (4 items), Role limitations due to emotional problems (4 items), Energy/fatigue (4 items), Emotional well-being (5 items), Social functioning (2 items), Pain (2 items), General health (5 items). Aggregate scores for each domain range from 0 to 100, compiled as a percentage - where the higher the score, the more favorable the health state of the patient.
Time frame: baseline, week 3, week 6
Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.
Time frame: baseline, week 3, week 6
Changes in inflammatory urinary biomarkers
Urine samples will be obtained at baseline and at the end of the 4 month exercise period from participants. The urine will then be analyzed for biomarkers of inflammation using a Luminex High Performance Assay. Any decrease in the levels of biomarkers of inflammation in the urine is the outcome of interest.
Time frame: baseline, 6 weeks
Post-regimen review
After the exercise program concludes, participants will be contacted via phone or email and asked to comment on the program and make suggestions for improvement. This will include things such as if they would recommend the program to friends/family, if they have continued to exercise and/or will continue to exercise on their own time, and any portions of the program they would change or do differently.
Time frame: after week 6
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Sep 2025, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences →