If you have been experiencing the symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), you may be eligible to participate in a clinical research study. IC/BPS affects 15 to 24 percent of adult women and has a significant impact on quality of life. The goal of this study is to compare the results of bladder directed therapy (bladder instillations) versus non-bladder physical therapy.

Why should I participate?

The purpose of clinical research is to look at the nature of disease and to develop improved methods to diagnose and treat disease.

What's involved?

If you meet the criteria to be included in the study, you will be scheduled to have:
• twice weekly treatment sessions for eight weeks
• two follow up appointments
• phone or mail monitoring every six months, up to five times after treatment completion

Compensation will be provided for study participation.

Who can participate?

If you are a female between the ages of 18 and 85, with urinary frequency, urgency and pelvic discomfort or pain for at least six months, you may be eligible to participate in a clinical research study.

Brief Title

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

Official Title

Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome

Brief Summary

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.

Detailed Description

This will be a prospective randomized trial of pelvic floor therapy vs. bladder directed
therapy. The study target population consists of females, aged 18 to 85 years of age with a
clinical diagnosis of IC/BPS and symptoms of chronic urinary frequency, pelvic
pain/discomfort, and/or urinary urgency. The approximate number of subjects that will be
enrolled in the study is 128, 64 women in each treatment group. Women who satisfy all of the
eligibility criteria will be enrolled in the study and randomized to receive bladder
treatments (instillation of medications into the bladder) or pelvic floor physical therapy.

Outcome measures will include validated questionnaires, voiding diaries, and Global Response
Assessment (GRA). The investigators also will evaluate changes in pelvic floor muscle tone
and discomfort pre and post treatment, and their relationship to symptom changes. Finally,
the investigators will utilize their well-established urine and serum biomarkers evaluations
pre and post treatment to determine if they correlate with symptom change.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.