Status:
COMPLETED
Hypnosis for Bladder Pain Syndrome
Lead Sponsor:
University of Pennsylvania
Conditions:
Bladder Pain Syndrome
Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a pilot randomized control trial of 30 women with interstitial cystitis/bladder pain syndrome to determine the feasibility of delivering a hypnosis intervention or usual care on bladder pain (...
Detailed Description
Available treatments do not provide adequate relief for bladder pain syndrome/interstitial cystitis (BPS/IC), a chronic painful condition that affects 10 million women in the United States. The invest...
Eligibility Criteria
Inclusion
- Women greater than or equal to 18 years old who are diagnosed with interstitial cystitis or bladder pain syndrome.
- Meet AUA criteria for BPS/IC: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks, in the absence of infection or other identifiable causes. - A minimum score greater than or equal to 8 on the Interstitial Cystitis Symptom Index and Problem Index will be required for participation.
- A negative urinalysis or urine culture within 2 months,
- Fluent in English language,
- No changes in IC treatment regimen within 4 weeks of beginning assigned intervention.
Exclusion
- Patients who are treatment naive or undergoing 3rd line or higher treatments,
- Pregnant or lactating,
- Unevaluated hematuria, urinary retention,
- A history of cystectomy, urinary diversion or augmentation cystoplasty,
- Other sources of bladder pain (stone, uncontrolled recurrent UTI, radiation cystitis, bladder cancer) or who have a primary diagnosis of another chronic pain condition (such as back pain, fibromyalgia).
Key Trial Info
Start Date :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04010513
Start Date
October 3 2019
End Date
August 15 2020
Last Update
February 17 2021
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104