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Supervised Exercise for Interstitial Cystitis (IC/BPS Trial)

N/A

Recruiting

Led By Stephen J Walker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Study participants must be fully ambulatory without the use of a cane, walker, or wheelchair

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 3, week 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore if exercise can reduce symptoms and improve quality of life for people with interstitial cystitis/bladder pain syndrome.

Who is the study for?

This trial is for English-speaking adult women aged 18-80 with a diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), confirmed by a specialist. Participants must be able to walk without assistance and tolerate moderate exercise, not pregnant, and free from certain conditions like bladder cancer or neurological disorders.

What is being tested?

The study tests whether a supervised exercise regimen can alleviate symptoms of IC/BPS and improve the quality of life in patients. It explores the effectiveness of physical activity as part of treatment for this chronic bladder condition.

What are the potential side effects?

While specific side effects are not listed for an exercise regimen, participants may experience typical exercise-related discomforts such as muscle soreness or fatigue. Any significant health risks will likely be assessed by physicians before clearance to participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18-79 with diagnosed interstitial cystitis/bladder pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can walk without any help from devices like canes or wheelchairs.

Select...

I have a history of specific cancers or conditions affecting my bladder or nervous system, or I am currently experiencing an active genital herpes episode.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 3, week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 3, week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interstitial Cystitis Problem (ICPI) Index Scores

Interstitial Cystitis Symptom Index (ICSI) Scores

Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) Scores

Secondary study objectives

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

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

Other study objectives

Changes in inflammatory urinary biomarkers

Post-regimen review

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exercise treatment groupExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise regimen

2004

Completed Phase 2

~210

0 / 3Eligibility criteria met