Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

NCT02870738 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 2016-253
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome; Cystitis, Interstitial

Outcome Measures

Primary Outcomes (1)

• 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)

  Week 9 (one week after last treatment)

Secondary Outcomes (1)

• Change in symptoms

  Week 9 (one week after last treatment)

Study Arms (2)

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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

Procedure: Pelvic Floor Physical Therapy

Bladder Instillations

ACTIVE COMPARATOR

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

Drug: Bladder Instillations

Interventions

Bladder Instillations DRUG

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

Also known as: xylocaine, triamcinolone

Bladder Instillations

Pelvic Floor Physical Therapy PROCEDURE

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

Also known as: Myofascial release

Pelvic Floor Physical Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Baylor College of Medicine: collaborator
• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Myofascial Release Therapy; Administration, Intravesical; Lidocaine; Triamcinolone

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Administration, Topical; Drug Administration Routes; Drug Therapy; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kenneth M Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Urology

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: April 21, 2017
• Primary Completion: February 3, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)