Cystitis, InterstitialPhase 2NCT02870738
Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
A Phase 2 study testing Pelvic Floor Physical Therapy and Bladder Instillations in people with Cystitis, Interstitial and Painful Bladder Syndrome, run by Corewell Health East at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cystitis, Interstitial, Painful Bladder Syndrome
- What is being tested?
- Pelvic Floor Physical Therapy and Bladder Instillations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2017to Aug 2027
- Phase
- Phase 2
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18 to 85 years
- History of patient self-reported of IC/BPS symptoms for at least 6 months.
- Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months
- Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint.
Who cannot join
- Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer
- Hunner's lesions found on screening cystoscopy
- Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months
- Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential.
- Pain, frequency, and/or urgency symptoms only present during menses
- Clinically confirmed urinary tract infection at time of screening
Show all 14Show fewer
- Participant unable to tolerate insertion of one or two vaginal examining fingers (e.g. Vulvar allodynia)
- Participant had prior course of physical therapy (PT) that included internal (vaginal and/or rectal) manual therapy with connective tissue manipulation by physical therapist for the same symptoms within the past 3 months (prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary)
- Participant in the opinion of the investigator has a relevant neurologic disorder that affects bladder and/or neuromuscular function
- Participant has/reports any severe, debilitating or urgent concurrent, medical condition
- Participant has a potentially significant pelvic pathology or abnormality on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc., that in the investigators' judgment, could cause or contribute to the clinical symptoms, or require treatment
- Any other condition which, in the investigator's judgment, may increase risk to subject's welfare
- Participation in an investigational trial that uses a study treatment less than 6 months from the date of the screening visit
- Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome
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.
Read the detailed description
This will be a prospective randomized trial of pelvic floor therapy vs. bladder directed therapy. The study target population consists of females, aged 18 to 85 years of age with a clinical diagnosis of IC/BPS and symptoms of chronic urinary frequency, pelvic pain/discomfort, and/or urinary urgency. The approximate number of subjects that will be enrolled in the study is 128, 64 women in each treatment group. Women who satisfy all of the eligibility criteria will be enrolled in the study and randomized to receive bladder treatments (instillation of medications into the bladder) or pelvic floor physical therapy.
Outcome measures will include validated questionnaires, voiding diaries, and Global Response Assessment (GRA). The investigators also will evaluate changes in pelvic floor muscle tone and discomfort pre and post treatment, and their relationship to symptom changes. Finally, the investigators will utilize their well-established urine and serum biomarkers evaluations pre and post treatment to determine if they correlate with symptom change.
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Being tested
- Pelvic Floor Physical Therapy, Bladder Instillations
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Physical TherapyProcedure or surgery
Also called Myofascial release
Internal and/or external myofascial release of the pelvic floor muscles
Bladder InstillationsDrug
Also called xylocaine, triamcinolone
A solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | One hour of pelvic floor physical therapy twice weekly for 8 weeks Receives: Procedure: Pelvic Floor Physical Therapy |
| Bladder Instillations | Active comparator | Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks Receives: Drug: Bladder Instillations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markedly/Moderately Improved on Global Response Assessments
Proportion of patients in each treatment arm that report Marked or Moderate improvement in symptoms on Global Response Assessments at Week 9 (one week after last treatment)
Measured: Week 9 (one week after last treatment)
Secondary outcomes (1)
Change in symptoms
Change in pelvic floor examination findings and symptoms as measured by questionnaires at Week 9 (one week after last treatment)
Measured: Week 9 (one week after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start21 Apr 2017
- Primary completion3 Feb 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystitis, InterstitialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, MD, Principal investigator, Corewell Health William Beaumont University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870738
- Sponsor's protocol ID
- 2016-253
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2016
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT02870738
- Acronym / sponsor ID
- 2016-253
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- 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.
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.
Detailed description
This will be a prospective randomized trial of pelvic floor therapy vs. bladder directed therapy. The study target population consists of females, aged 18 to 85 years of age with a clinical diagnosis of IC/BPS and symptoms of chronic urinary frequency, pelvic pain/discomfort, and/or urinary urgency. The approximate number of subjects that will be enrolled in the study is 128, 64 women in each treatment group. Women who satisfy all of the eligibility criteria will be enrolled in the study and randomized to receive bladder treatments (instillation of medications into the bladder) or pelvic floor physical therapy.
Outcome measures will include validated questionnaires, voiding diaries, and Global Response Assessment (GRA). The investigators also will evaluate changes in pelvic floor muscle tone and discomfort pre and post treatment, and their relationship to symptom changes. Finally, the investigators will utilize their well-established urine and serum biomarkers evaluations pre and post treatment to determine if they correlate with symptom change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | Procedure: Pelvic Floor Physical TherapyOne hour of pelvic floor physical therapy twice weekly for 8 weeks |
| Bladder Instillations | Active comparator | Drug: Bladder InstillationsBladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age 18 to 85 years
- History of patient self-reported of IC/BPS symptoms for at least 6 months.
- Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months
- Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint.
Key exclusion criteria (14 listed)
- Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer
- Hunner's lesions found on screening cystoscopy
- Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months
- Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential.
- Pain, frequency, and/or urgency symptoms only present during menses
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 |
|---|---|---|
| Pelvic Floor Physical TherapyAlso: Myofascial releaseInternal and/or external myofascial release of the pelvic floor muscles | Procedure or surgery | Pelvic Floor Physical Therapy |
| Bladder InstillationsAlso: xylocaine, triamcinoloneA solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter | Drug | Bladder Instillations |
Primary outcome
Markedly/Moderately Improved on Global Response Assessments
Time frame: Week 9 (one week after last treatment)
Proportion of patients in each treatment arm that report Marked or Moderate improvement in symptoms on Global Response Assessments at Week 9 (one week after last treatment)
1 secondary outcome
Change in symptoms
Time frame: Week 9 (one week after last treatment)
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 9 Jul 2026.
- Derived from this study: PubMed 32734597Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kenneth M Peters, MD principal investigator
Corewell Health William Beaumont University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pelvic Floor Physical Therapy and Bladder Instillations in people with Cystitis, Interstitial and Painful Bladder Syndrome, run by Corewell Health East 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markedly/Moderately Improved on Global Response Assessments (time frame: Week 9 (one week after last treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870738, which also lists 1 linked publication.
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 9 Jul 2026.