Acupuncture First for IC/BPS

NCT ID: NCT06366269

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Bladder Pain Syndrome Interstitial Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators
Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

traditional and electroacupuncture

Behavioral management

Intervention Type BEHAVIORAL

based on American urologic association guidelines

Physical therapy

Intervention Type OTHER

pelvic floor with biofeedback

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.

Group Type ACTIVE_COMPARATOR

Behavioral management

Intervention Type BEHAVIORAL

based on American urologic association guidelines

Physical therapy

Intervention Type OTHER

pelvic floor with biofeedback

Interventions

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Acupuncture

traditional and electroacupuncture

Intervention Type OTHER

Behavioral management

based on American urologic association guidelines

Intervention Type BEHAVIORAL

Physical therapy

pelvic floor with biofeedback

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladder pain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause"
* Negative urine culture
* Has completed cystoscopic evaluation for IC/BPS

Exclusion Criteria

* History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
* History of overactive bladder
* History of bleeding disorder or are currently on chronic anti-coagulation
* Post-void residual \>100mL
* Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox
* Prior bladder augmentation
* Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
* Currently pregnant (if applicable, based on self-report)
* Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
* Non-English speaking and reading
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Sheyn

Physician, UHMG

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Sheyn, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Abou Zeki

Role: CONTACT

216-286-0603

Gabriella Rustia, MD

Role: CONTACT

216-202-0597

Facility Contacts

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Gabriella Rustia, MD

Role: primary

216-202-0597

Other Identifiers

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STUDY20240374

Identifier Type: -

Identifier Source: org_study_id

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