Phase
Condition
Bladder Disorders
Interstitial Cystitis
Gynecological Infections
Treatment
Bladder Instillations
Pelvic Floor Physical Therapy
Clinical Study ID
Ages 18-85 Female
Study Summary
Eligibility Criteria
Inclusion
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-childbearing age with no menstrual period for the past 12 months
Must be willing to not start any new medication known to affect bladder or musclefunction, and to ideally remain on a stable dose of all other medications throughthe secondary endpoint.
Exclusion
Exclusion Criteria:
Active urethral or ureteral calculi, urethral diverticulum, history of pelvicradiation 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 symptomswithin the past 3 months
Lactation, pregnancy, or refusal of medically approved/reliable birth control inwomen 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 byphysical therapist for the same symptoms within the past 3 months (prior treatmentby therapist with biofeedback, electrical stimulation, or pelvic floor exercises isnot exclusionary)
Participant in the opinion of the investigator has a relevant neurologic disorderthat affects bladder and/or neuromuscular function
Participant has/reports any severe, debilitating or urgent concurrent, medicalcondition
Participant has a potentially significant pelvic pathology or abnormality onexamination or prior imaging, including prolapse beyond the hymenal ring, pelvicmass, etc., that in the investigators' judgment, could cause or contribute to theclinical symptoms, or require treatment
Any other condition which, in the investigator's judgment, may increase risk tosubject's welfare
Participation in an investigational trial that uses a study treatment less than 6months 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.
Study Design
Study Description
Connect with a study center
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.