Bladder Directed Vs. Pelvic Floor Therapy in IC/BPS

Launched by WILLIAM BEAUMONT HOSPITALS · Aug 12, 2016

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for women suffering from interstitial cystitis/bladder pain syndrome (IC/BPS), a condition that causes frequent and urgent urination as well as chronic pain in the pelvic area. The trial will study the effects of bladder instillations (a treatment that delivers medication directly into the bladder) versus pelvic floor physical therapy, which focuses on relaxing and strengthening the muscles in the pelvic area. The goal is to understand if tight pelvic muscles are contributing to the symptoms of IC/BPS and whether addressing these muscles can improve patients' quality of life.

To participate in this trial, women aged 18 to 85 who have reported IC/BPS symptoms for at least six months may be eligible, provided they are not currently pregnant or breastfeeding and do not have certain medical conditions that could complicate their treatment. Participants can expect to receive either the bladder treatment or physical therapy and will be closely monitored throughout the study. It's important to know that this research aims to improve diagnosis and treatment options for IC/BPS, potentially leading to better outcomes for many women who have been suffering for years.

Gender

FEMALE

Eligibility 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.