Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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3 April 2023 |
Main ID: |
NCT02870738 |
Date of registration:
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12/08/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
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Scientific title:
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Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome |
Date of first enrolment:
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April 21, 2017 |
Target sample size:
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128 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02870738 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Lydia Kosovich, RN |
Address:
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Telephone:
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248-551-3291 |
Email:
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Lydia.Kosovich@Beaumont.org |
Affiliation:
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Name:
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Kenneth M Peters, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Beaumont Hospital-Royal Oak |
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Name:
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Kenneth M Peters, MD |
Address:
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Telephone:
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Email:
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kmpeters@beaumont.edu |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Painful Bladder Syndrome
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Cystitis, Interstitial
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Intervention(s)
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Drug: Bladder Instillations
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Procedure: Pelvic Floor Physical Therapy
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Primary Outcome(s)
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Markedly/Moderately Improved on Global Response Assessments
[Time Frame: Week 9 (one week after last treatment)]
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Secondary Outcome(s)
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Change in symptoms
[Time Frame: Week 9 (one week after last treatment)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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