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Investigation of PEMF Therapy for Female Patients With IC/BPS

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 2026 → Jan 2027
See other at-risk trials from Wake Forest University Health Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Sep 2026 to Jan 2027 Show 5 more changesShow less
    • Study completion date: Feb 2027 to Jan 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description shortened, about 20 words
    • Publications: details revised at 5 of 5 entries
  2. Minor Primary completion moved earlier from Nov 1, 2026 to Sep 2026
    • Study completion pushed from Jan 1, 2027 to Feb 2027
    • Site contact updated
    v16
  3. Notable Primary completion date: Apr 2026 to Nov 1, 2026
    • Study completion date: Apr 2026 to Jan 1, 2027
    v15
  4. Minor Primary and study completion dates: Nov 2025 to Apr 2026v14
  5. Minor Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Primary and study completion dates: Apr 2025 to Nov 2025v12
  2. Minor 3 versions Re-verified since Oct 24, 2023, no change to tracked fieldsv9-v11
  3. Minor Site contact updatedv8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Aug 29, 2022
    • Site details revised
    v6
  6. Notable Start date: Jul 2022 to Sep 2022v5
  7. Minor Start date: Jun 2022 to Jul 2022v4
  8. Notable Start date: Apr 2022 to Jun 2022v3
  9. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.
Trial Details
NCT Number NCT05149573
Lead Sponsor Wake Forest University Health Sciences
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome
Related terms Cystitis, Interstitial
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov