- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870738
Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Lydia Kosovich, RN
- Phone Number: 248-551-3291
- Email: Lydia.Kosovich@Beaumont.org
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- William Beaumont Hospital
-
Contact:
- Kenneth M Peters, MD
- Email: kmpeters@beaumont.edu
-
Principal Investigator:
- Kenneth M Peters, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pelvic Floor Physical Therapy
One hour of pelvic floor physical therapy twice weekly for 8 weeks
|
Internal and/or external myofascial release of the pelvic floor muscles
Other Names:
|
Active Comparator: Bladder Instillations
Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks
|
A solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Markedly/Moderately Improved on Global Response Assessments
Time Frame: Week 9 (one week after last treatment)
|
Proportion of patients in each treatment arm that report Marked or Moderate improvement in symptoms on Global Response Assessments at Week 9 (one week after last treatment)
|
Week 9 (one week after last treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms
Time Frame: Week 9 (one week after last treatment)
|
Change in pelvic floor examination findings and symptoms as measured by questionnaires at Week 9 (one week after last treatment)
|
Week 9 (one week after last treatment)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth M Peters, MD, Beaumont Hospital-Royal Oak
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Urinary Bladder Diseases
- Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Syndrome
- Cystitis
- Cystitis, Interstitial
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
Other Study ID Numbers
- 2016-253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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