Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome

NCT05699551 | Withdrawn

• 1 other identifier: IRB00092907
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the efficacy of exercise to improve interstitial cystitis/bladder pain syndrome symptoms and quality of life will be investigated.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

exercise; interstitial cystitis; bladder

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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

  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

  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

  week 6

Secondary Outcomes (2)

• Change in the Short Form 36 (SF-36) Health Survey Scores

  baseline, week 3, week 6

• Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores

  baseline, week 3, week 6

Other Outcomes (2)

• Changes in inflammatory urinary biomarkers

  baseline, 6 weeks

• Post-regimen review

  after week 6

Study Arms (1)

Exercise treatment group

EXPERIMENTAL

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

Interventions

Exercise regimen BEHAVIORAL

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.

Exercise treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Must speak English
• The clinical diagnosis of IC/BPS will be based on the recently published American Urological Association Guidelines definition: "An unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes"
• The diagnosis will be confirmed by a urologist who specializes in the treatment of patients with IC/BPS

You may not qualify if:

• Study participants must be fully ambulatory without the use of a cane, walker, or wheelchair
• Study participants must be able to tolerate moderate aerobic exercise. It will also be required that a physician clear any subjects entering the exercise program who have signs and symptoms suggestive of cardiovascular, cerebrovascular, metabolic, or renal disease and have been active 3 days per week for 30 minutes each day
• Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, the current placement of a catheter, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation cystitis, bladder tuberculosis, or are experiencing an active genital herpes episode
• Pregnant women are not eligible for this study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of North Carolina, Greensboro: collaborator

MeSH Terms

Conditions

Cystitis, Interstitial; Motor Activity

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Stephen J Walker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: May 10, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share