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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Aug 2026 to Aug 2027v21
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 2026 to Feb 3, 2026
    • Site details revised
    v20
  3. Primary completion date: Mar 2026 to Aug 2026v19
  4. Primary completion date: Jul 2025 to Mar 2026
    • Study completion date: Aug 2025 to Aug 2026
    • Study site revised
    v18
  5. Primary completion date: Aug 2025 to Jul 2025
    • Study completion date: Aug 2026 to Aug 2025
    • Site contact updated
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Re-verified, no change to tracked fieldsv16
  2. Primary completion date: Aug 2023 to Aug 2025
    • Study completion date: Aug 2024 to Aug 2026
    v15
  3. Re-verified, no change to tracked fieldsv14
  4. Primary completion date: Aug 2022 to Aug 2023
    • Study completion date: Aug 2022 to Aug 2024
    v13
  5. Primary and study completion dates: Aug 2021 to Aug 2022v12
  6. Primary and study completion dates: Aug 2020 to Aug 2021v11
  7. Primary completion date: Aug 2019 to Aug 2020v10
  8. Re-verified, no change to tracked fieldsv9
  9. Eligibility criteria shortened, about 25 wordsv8
  10. Eligibility criteria revisedv7
  11. Eligibility criteria expanded, about 9 wordsv6
  12. Re-verified, no change to tracked fieldsv5
  13. Phase: Not applicable to Phase 2
    • Start date changed from estimate of Mar 2017 to Apr 21, 2017
    v4
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2016 to Mar 2017
    • Site details revised
    v3
  15. Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02870738
Lead Sponsor Corewell Health East
Collaborators: Baylor College of Medicine
Conditions
(from sponsor)		 Cystitis, Interstitial, Painful Bladder Syndrome
Related terms Cystitis, Interstitial
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov