Clinical trial NCT05699551: Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome
Official title: Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: exercise
interstitial cystitis
bladder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Greensboro
First posted: 2023-01-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interstitial Cystitis Symptom Index (ICSI) Scores
timeFrame: baseline
measure: Interstitial Cystitis Problem (ICPI) Index Scores
timeFrame: week 3
measure: Interstitial Cystitis Symptom Index (ICSI) Scores
timeFrame: week 3
measure: Interstitial Cystitis Problem (ICPI) Index Scores
timeFrame: week 6
measure: Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
timeFrame: baseline
measure: Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
timeFrame: week 3
measure: Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores
timeFrame: week 6
Secondary outcomes:
measure: Change in the Short Form 36 (SF-36) Health Survey Scores
timeFrame: baseline, week 3, week 6
measure: Changes in Composite Autonomic Symptom Score (COMPASS-31) Scores
timeFrame: baseline, week 3, week 6
Other outcomes:
measure: Changes in inflammatory urinary biomarkers
timeFrame: baseline, 6 weeks
measure: Post-regimen review
timeFrame: after week 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen J Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: