Acupuncture First for IC/BPS

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06366269
Status
Recruiting
Apply to this trial

Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Acupuncture — OTHER
    traditional and electroacupuncture
  • Behavioral management — BEHAVIORAL
    based on American urologic association guidelines
  • Physical therapy — OTHER
    pelvic floor with biofeedback

Study Details

The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is: Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. Participants will * complete surveys about their bladder pain symptoms * make behavioral changes that have been shown to improve bladder pain symptoms * attend six (6) weekly acupuncture sessions * attend six (6) weekly physical therapy sessions after finishing acupuncture

Key Dates

Start date
Jan 21, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acupuncture
    Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain. They will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy.
  • Active Comparator: Behavioral Management
    Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain for six (6) weeks before starting pelvic floor physical therapy.

Primary Outcome Measure

O'Leary-Sant Interstitial Cystitis Index (OLSICI) [ Time Frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalsClevelandOhio44106
Gabriella Rustia, MD
[email protected]
216-202-0597

Find similar trials in Cleveland, OH

By research site
University Hospitals· Cleveland, OH

Related Studies