Recruiting

Supervised Exercise

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05699551

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise regimen

Study Details

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

Study ID

NCT05699551

Start date

May 10, 2023

Status verified date

Oct, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise treatment group

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.

Interventions

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.

Primary outcome measure

  • Interstitial Cystitis Symptom Index (ICSI) Scores [ Time Frame: baseline ]
  • Interstitial Cystitis Problem (ICPI) Index Scores [ Time Frame: week 3 ]
  • Interstitial Cystitis Symptom Index (ICSI) Scores [ Time Frame: week 3 ]
  • Interstitial Cystitis Problem (ICPI) Index Scores [ Time Frame: week 6 ]
  • Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores [ Time Frame: baseline ]
  • Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores [ Time Frame: week 3 ]
  • Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores [ Time Frame: week 6 ]

Central Contacts and Locations

Central contacts

Stephen J Walker, PhD

3367493574swalker@wakehealth.edu

Rory Ritts, MD

336-713-1693rritts@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Stephen J Walker, PhD

336-749-3574swalker@wakehealth.edu

Rory A Ritts, MD

3367131693rritts@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 26, 2024

Last verified

Oct, 2024

Keywords

  • exercise
  • interstitial cystitis
  • bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2024-10-26.