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Bladder Instillations vs. Pelvic Floor Therapy for Interstitial Cystitis
Study Summary
This trial will compare a bladder directed therapy to pelvic floor physical therapy to assess the role of the pelvic floor in adult women with IC/BPS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't had bladder treatments for IC/BPS symptoms in the last 3 months.You are unable to tolerate having one or two fingers inserted into your vagina for examination.I've had physical therapy with internal manual techniques for my symptoms in the last 3 months.I have a nerve or muscle condition affecting my bladder.I have a pelvic condition that might need treatment or could be causing my symptoms.I am female.I agree not to start new meds that could affect my bladder or muscles and to keep my other meds stable.You have been diagnosed with a specific type of bladder lesion called Hunner's lesions during a screening test.I am using birth control, am surgically sterile, or have not had a period for 12 months.I only experience pain or frequent/urgent bathroom needs during my period.I have a history of specific urinary or bladder conditions or treatments.I currently have a urinary tract infection.I have had symptoms of interstitial cystitis/bladder pain syndrome for at least 6 months.I am between 18 and 85 years old.
- Group 1: Pelvic Floor Physical Therapy
- Group 2: Bladder Instillations
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Pelvic Floor Physical Therapy a safe practice for individuals?
"Pelvic Floor Physical Therapy is considered a moderately safe medical intervention with a rating of 2 as this Phase 2 trial has not yet collected any data regarding its efficacy."
Is this medical study open to people aged 50 and over?
"Recruitment for this trial is open to adults who are at least 18 years old and not older than 85."
What is the aggregate sum of individuals involved in this research?
"Affirmative. The clinical trial database on the website indicates that this research endeavor, which was initially posted on April 21st 2017, is currently recruiting candidates. Around 128 individuals must be enrolled at 1 medical site."
Are enrollment applications being accepted for this medical experiment at present?
"Affirmative. Clinicaltrials.gov presently reflects that this research is actively recruiting subjects, with the initial posting being on April 21st 2017 and the most recent update occurring May 6th 2022. To complete their study design, 128 persons need to be recruited from one clinical trial location."
What disorders can be effectively addressed with Pelvic Floor Physical Therapy?
"Pelvic Floor Physical Therapy can be a beneficial treatment for patients recovering from minor burns, ulcerative colitis and organ transplants."
Are there any precedent studies that have utilized Pelvic Floor Physical Therapy?
"Presently, 155 research studies pertaining to Pelvic Floor Physical Therapy are in progress. Of those active trials, 39 have entered Phase 3. Though the majority of these clinical trial sites are located within Chongqing, 1 164 locations around the world offer this type of therapy."
What criteria must a patient meet to participate in this clinical experiment?
"This clinical trial is recruiting 128 participants, aged between 18 and 85, who present with cystitis interstitial. To be eligible for the study, individuals must meet all of the following requirements: female gender; 6 months history of IC/BPS symptoms; use an approved method of birth control or declare themselves surgically sterile or post-menopausal with no menstrual period in the last 12 months; refraining from taking any medication known to influence bladder or muscle function until after completion of secondary endpoint assessment; and keeping their dosage stable on other medications during this time frame."
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