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Bladder Instillations vs. Pelvic Floor Therapy for Interstitial Cystitis
Phase 2
Recruiting
Led By Kenneth M Peters, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
History of patient self-reported of IC/BPS symptoms for at least 6 months
Must not have
Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer
Clinically confirmed urinary tract infection at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9 (one week after last treatment)
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for women aged 18-85 with interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms for at least 6 months. They must not be pregnant, breastfeeding, or starting new medications affecting bladder/muscle function and should maintain a stable dose of current meds.
What is being tested?
The study compares bladder instillations (bladder directed therapy) with pelvic floor physical therapy to see which is more effective in treating pelvic pain and voiding dysfunction caused by IC/BPS in adult women without ulcerative conditions.
What are the potential side effects?
Potential side effects may include discomfort from the treatments like soreness from physical therapy or irritation from bladder instillations. The exact side effects will depend on the individual's response to these therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I have had symptoms of interstitial cystitis/bladder pain syndrome for at least 6 months.
Select...
I am between 18 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of specific urinary or bladder conditions or treatments.
Select...
I currently have a urinary tract infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 9 (one week after last treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9 (one week after last treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Markedly/Moderately Improved on Global Response Assessments
Secondary study objectives
Change in symptoms
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Pelvic Floor Physical TherapyActive Control1 Intervention
One hour of pelvic floor physical therapy twice weekly for 8 weeks
Group II: Bladder InstillationsActive Control1 Intervention
Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks
Find a Location
Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
151 Previous Clinical Trials
112,482 Total Patients Enrolled
11 Trials studying Interstitial Cystitis
4,259 Patients Enrolled for Interstitial Cystitis
Baylor College of MedicineOTHER
1,024 Previous Clinical Trials
6,029,382 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
46 Patients Enrolled for Interstitial Cystitis
Kenneth M Peters, MD4.323 ReviewsPrincipal Investigator - Beaumont Hospital-Royal Oak
William Beaumont Hospitals
12 Previous Clinical Trials
4,192 Total Patients Enrolled
4 Trials studying Interstitial Cystitis
3,604 Patients Enrolled for Interstitial Cystitis
5Patient Review
Dr. Peters is nothing short of a miracle worker. I had given up hope after being told by numerous other doctors that my condition was untreatable and that I would just have to learn to live with the pain. But Dr. Peters was able to help me and I am now pain-free and living a normal, happy life. I am forever grateful to him.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pelvic Floor Physical Therapy
- Group 2: Bladder Instillations
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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