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

Last updated: October 23, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Gynecological Infections

Urinary Tract Infections

Treatment

Exercise regimen

Clinical Study ID

NCT05699551
IRB00092907
  • Ages 18-80
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult females (>18 years and <80 years) with a previously established clinicaldiagnosis of Interstitial cystitis/bladder pain syndrome (IC/BPS) will be eligibleto participate

  • Must speak English

  • The clinical diagnosis of IC/BPS will be based on the recently published AmericanUrological Association Guidelines definition: "An unpleasant sensation (pain,pressure, or discomfort) perceived to be related to the urinary bladder, associatedwith lower urinary tract symptoms for more than six weeks duration, in the absenceof infection or other identifiable causes"

  • The diagnosis will be confirmed by a urologist who specializes in the treatment ofpatients with IC/BPS

Exclusion

Exclusion Criteria:

  • Study participants must be fully ambulatory without the use of a cane, walker, orwheelchair

  • Study participants must be able to tolerate moderate aerobic exercise. It will alsobe required that a physician clear any subjects entering the exercise program whohave signs and symptoms suggestive of cardiovascular, cerebrovascular, metabolic, orrenal 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, thecurrent 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 genitalherpes episode

  • Pregnant women are not eligible for this study

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Exercise regimen
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
September 30, 2025

Study Description

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.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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