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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

Primary Purpose

Cystitis, Interstitial, Painful Bladder Syndrome

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Pelvic Floor Physical Therapy

Bladder Instillations

About this trial

This is an interventional treatment trial for Cystitis, Interstitial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

William Beaumont HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pelvic Floor Physical Therapy

Bladder Instillations

Arm Description

One hour of pelvic floor physical therapy twice weekly for 8 weeks

Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks

Outcomes

Primary Outcome Measures

Markedly/Moderately Improved on Global Response Assessments

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)

Secondary Outcome Measures

Change in symptoms

Change in pelvic floor examination findings and symptoms as measured by questionnaires at Week 9 (one week after last treatment)

Full Information

NCT ID

NCT02870738

First Posted

August 12, 2016

Last Updated

March 20, 2023

Sponsor

William Beaumont Hospitals

Collaborators

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02870738

Brief Title

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

Official Title

Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 21, 2017 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

William Beaumont Hospitals

Collaborators

Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystitis, Interstitial, Painful Bladder Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pelvic Floor Physical Therapy

Arm Type

Active Comparator

Arm Description

One hour of pelvic floor physical therapy twice weekly for 8 weeks

Arm Title

Bladder Instillations

Arm Type

Active Comparator

Arm Description

Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks

Intervention Type

Procedure

Intervention Name(s)

Pelvic Floor Physical Therapy

Other Intervention Name(s)

Myofascial release

Intervention Description

Internal and/or external myofascial release of the pelvic floor muscles

Intervention Type

Drug

Intervention Name(s)

Bladder Instillations

Other Intervention Name(s)

xylocaine, triamcinolone

Intervention Description

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

Primary Outcome Measure Information:

Title

Markedly/Moderately Improved on Global Response Assessments

Description

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)

Time Frame

Week 9 (one week after last treatment)

Secondary Outcome Measure Information:

Title

Change in symptoms

Description

Change in pelvic floor examination findings and symptoms as measured by questionnaires at Week 9 (one week after last treatment)

Time Frame

Week 9 (one week after last treatment)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lydia Kosovich, RN

Phone

248-551-3291

Lydia.Kosovich@Beaumont.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Peters, MD

Organizational Affiliation

Beaumont Hospital-Royal Oak

Official's Role

Principal Investigator

Facility Information:

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth M Peters, MD

kmpeters@beaumont.edu

First Name & Middle Initial & Last Name & Degree

Kenneth M Peters, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32734597

Citation

Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

Results Reference

derived

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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

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