Bladder Instillations vs. Pelvic Floor Therapy for Interstitial Cystitis
Trial Summary
What is the purpose of this trial?
Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective treatment.
Will I have to stop taking my current medications?
The trial requires that you do not start any new medications that affect bladder or muscle function, and ideally, you should stay on a stable dose of your current medications throughout the trial.
What data supports the effectiveness of bladder instillations as a treatment for interstitial cystitis?
Research shows that bladder instillation therapy, which involves putting medication directly into the bladder, is a common treatment for interstitial cystitis, especially when other treatments haven't worked. Studies have explored the safety and potential benefits of using liposomes (tiny fat particles) in bladder instillations, suggesting it could be a promising option.12345
Is bladder instillation therapy or pelvic floor muscle training safe for humans?
Bladder instillation therapy, which involves putting medication directly into the bladder, is commonly used for interstitial cystitis/bladder pain syndrome and is generally considered safe. Pelvic floor muscle training, which includes exercises to strengthen pelvic muscles, is also safe and effective for conditions like urinary incontinence and pelvic organ prolapse.23678
How is the treatment of bladder instillations and pelvic floor therapy unique for interstitial cystitis?
Bladder instillations involve directly introducing medication into the bladder, which can provide targeted relief for interstitial cystitis when other treatments fail. Pelvic floor therapy focuses on strengthening and relaxing the muscles around the bladder, offering a non-drug approach to managing symptoms.123910
Research Team
Kenneth M Peters, MD
Principal Investigator
Beaumont Hospital-Royal Oak
Eligibility Criteria
This trial is for women aged 18-85 with interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms for at least 6 months. They must not be pregnant, breastfeeding, or starting new medications affecting bladder/muscle function and should maintain a stable dose of current meds.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either bladder instillations or pelvic floor physical therapy twice weekly for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bladder Instillations
- Pelvic Floor Physical Therapy
Bladder Instillations is already approved in United States, Canada, European Union for the following indications:
- Interstitial cystitis/bladder pain syndrome (IC/BPS)
- Interstitial cystitis/bladder pain syndrome (IC/BPS)
- Interstitial cystitis/bladder pain syndrome (IC/BPS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor
Baylor College of Medicine
Collaborator