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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

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ClinicalTrials.gov Identifier: NCT02870738
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Kenneth M Peters, MD, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Painful Bladder Syndrome Procedure: Pelvic Floor Physical Therapy Drug: Bladder Instillations Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pelvic Floor Physical Therapy
One hour of pelvic floor physical therapy twice weekly for 8 weeks
Procedure: Pelvic Floor Physical Therapy
Internal and/or external myofascial release of the pelvic floor muscles
Other Name: Myofascial release

Active Comparator: Bladder Instillations
Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks
Drug: Bladder Instillations
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 Name: xylocaine, triamcinolone




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age 18 to 85 years
  • History of clinical diagnosis of IC/BPS (patient self report)
  • 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
  • Mean urinary frequency of at least 8 times per 24 hours on three day voiding diary
  • Mean pelvic pain/discomfort score of 3 or greater (0-10 scale) on at least one day of the three day voiding diary
  • Mean urinary urgency score of 2 or greater (0-5 scale) on three day voiding diary
  • Self reported discomfort or pain in the pelvic region that has been present for at least six months
  • Must be willing to not start any new medication known to affect bladder or muscle function, and to 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870738


Contacts
Contact: Lydia Kosovich, RN 248-551-3291 Lydia.Kosovich@Beaumont.org

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kenneth M Peters, MD       kmpeters@beaumont.edu   
Principal Investigator: Kenneth M Peters, MD         
Sponsors and Collaborators
William Beaumont Hospitals
Baylor College of Medicine
Investigators
Principal Investigator: Kenneth M Peters, MD Beaumont Hospital-Royal Oak

Responsible Party: Kenneth M Peters, MD, Professor and Chairman of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT02870738     History of Changes
Other Study ID Numbers: 2016-253
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Syndrome
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs