Interstitial Cystitis/Bladder Pain Syndrome Clinical Research Study
NCT02870738 | Phase 2 | Interventional
Is pelvic pain an issue for you?
You may be eligible to participate in a clinical trial for an alternative treatment
Is pelvic pain an issue for you? You may be eligible to participate in a clinical trial for an alternative treatment
Details for the study
Treatments and/or Procedures
Inclusion Criteria: - Female - Age 18 to 85 years - History of clinical diagnosis of IC/BPS (patient self report) - 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 - Mean urinary frequency of at least 8 times per 24 hours on three day voiding diary - Mean pelvic pain/discomfort score of 3 or greater (0-10 scale) on at least one day of the three day voiding diary - Mean urinary urgency score of 2 or greater (0-5 scale) on three day voiding diary - Self reported discomfort or pain in the pelvic region that has been present for at least six months - Must be willing to not start any new medication known to affect bladder or muscle function, and to 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 12 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 12 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