Bladder Pain SyndromeNCT06366269
Acupuncture First for IC/BPS
A study testing Acupuncture, Behavioral management and Physical therapy in people with Bladder Pain Syndrome and Interstitial Cystitis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bladder Pain Syndrome, Interstitial Cystitis
- What is being tested?
- Acupuncture, Behavioral management and Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Gabriella Rustia, MD, 216-202-0597, gabriella.rustia@uhhospitals.org
About this study
Official title: Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
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.
Read more
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
- Conditions
- Bladder Pain Syndrome, Interstitial Cystitis
- Being tested
- Acupuncture, Behavioral management, Physical therapy
- Keywords
- acupuncture, bladder pain syndrome, interstitial cystitis
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
traditional and electroacupuncture
Behavioral managementBehavioural
based on American urologic association guidelines
Physical therapyOther
pelvic floor with biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Other: Acupuncture; Behavioral: Behavioral management; Other: Physical therapy |
| Behavioral Management | Active comparator | 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. Receives: Behavioral: Behavioral management; Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Leary-Sant Interstitial Cystitis Index (OLSICI)
Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.
Measured: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
Secondary outcomes (5)
Patient Global Impression of Improvement (PGI-I)
Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse).
Measured: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
Short Form (SF-36)
Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.
Measured: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
Genitourinary Pain Index (GUPI)
Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.
Measured: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
Number of additional treatments used during study period
Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine
Measured: 1 year post-treatment period
Number of unscheduled interactions
Unscheduled interactions include any phone calls, messages, or unplanned visits
Measured: 1 year post-treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start21 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366269
- Sponsor's protocol ID
- STUDY20240374
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT06366269
- Acronym / sponsor ID
- STUDY20240374
- Conditions
- Bladder Pain Syndrome, Interstitial Cystitis
- Keywords
- acupuncture, bladder pain syndrome, interstitial cystitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture, Behavioral: Behavioral management, Other: Physical therapyParticipants 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. |
| Behavioral Management | Active comparator | Behavioral: Behavioral management, Other: Physical therapyParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncturetraditional and electroacupuncture | Other | Acupuncture |
| Behavioral managementbased on American urologic association guidelines | Behavioural | Acupuncture, Behavioral Management |
| Physical therapypelvic floor with biofeedback | Other | Acupuncture, Behavioral Management |
Primary outcome
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)
Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.
5 secondary outcomes
Patient Global Impression of Improvement (PGI-I)
Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
Short Form (SF-36)
Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
Genitourinary Pain Index (GUPI)
Time frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
Number of additional treatments used during study period
Time frame: 1 year post-treatment period
Number of unscheduled interactions
Time frame: 1 year post-treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Bladder Pain Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Sheyn, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Behavioral management and Physical therapy in people with Bladder Pain Syndrome and Interstitial Cystitis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Abou Zeki (216-286-0603, Jessica.AbouZeki@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.