Comparing bladder therapy and pelvic floor therapy for bladder pain syndrome
Comparison of Bladder Directed and Pelvic Floor Therapy in Women with Interstitial Cystitis/Bladder Pain Syndrome
PHASE2 · William Beaumont Hospitals · NCT02870738
This study is testing whether bladder treatments or pelvic floor therapy works better for women with bladder pain syndrome to help relieve their symptoms.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | William Beaumont Hospitals (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT02870738 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of bladder-directed therapy, specifically bladder instillations, versus pelvic floor physical therapy in women suffering from interstitial cystitis/bladder pain syndrome (IC/BPS). The study aims to determine whether pelvic floor muscle tightness contributes to the symptoms of IC/BPS, which include chronic urinary frequency, urgency, and pelvic pain. A total of 128 women aged 18 to 85 will be enrolled and randomized into two treatment groups to assess symptom changes through validated questionnaires, voiding diaries, and biomarker evaluations. The goal is to improve diagnosis and treatment outcomes for women with IC/BPS by considering the role of pelvic floor dysfunction.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 85 with a clinical diagnosis of IC/BPS and a history of symptoms for at least six months.
Not a fit: Patients with active urethral or ureteral calculi, bladder cancer, or those who have had prior bladder instillations for IC/BPS symptoms within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for women suffering from IC/BPS, potentially reducing their symptoms and improving their quality of life.
How similar studies have performed: While the approach of comparing bladder-directed therapy and pelvic floor therapy is not widely tested, similar studies have shown promise in addressing pelvic floor dysfunction in relation to bladder symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 18 to 85 years * History of patient self-reported of IC/BPS symptoms for at least 6 months. * Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months * Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint. Exclusion Criteria: * Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer * Hunner's lesions found on screening cystoscopy * Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months * Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential. * Pain, frequency, and/or urgency symptoms only present during menses * Clinically confirmed urinary tract infection at time of screening * Participant unable to tolerate insertion of one or two vaginal examining fingers (e.g. Vulvar allodynia) * Participant had prior course of physical therapy (PT) that included internal (vaginal and/or rectal) manual therapy with connective tissue manipulation by physical therapist for the same symptoms within the past 3 months (prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary) * Participant in the opinion of the investigator has a relevant neurologic disorder that affects bladder and/or neuromuscular function * Participant has/reports any severe, debilitating or urgent concurrent, medical condition * Participant has a potentially significant pelvic pathology or abnormality on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc., that in the investigators' judgment, could cause or contribute to the clinical symptoms, or require treatment * Any other condition which, in the investigator's judgment, may increase risk to subject's welfare * Participation in an investigational trial that uses a study treatment less than 6 months from the date of the screening visit Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Where this trial is running
Royal Oak, Michigan
- William Beaumont Hospital — Royal Oak, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Kenneth M Peters, MD — Beaumont Hospital-Royal Oak
- Study coordinator: Lydia Kosovich, RN
- Email: Lydia.Kosovich@Beaumont.org
- Phone: 248-551-3291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystitis, Interstitial, Painful Bladder Syndrome