Hypnosis for Bladder Pain Syndrome

Not Applicable

Completed

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis
• Interventions: Behavioral: Hypnosis; Other: Standard of Care

• Registration Number: NCT04010513
• Lead Sponsor: University of Pennsylvania

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 (primary outcome) and cerebral blood flow (secondary outcome). Women in the hypnosis group will undergo treatment with three hypnotherapy sessions in addition to a mobile web-based hypnosis application. Neuroimagning (fMRI) will occur after the first follow up visit.

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 investigators plan to conduct a pilot randomized control study to determine the feasibility of conducting a combined CBT-hypnosis intervention vs. usual care in women with BPS/IC for a subgroup of women, we will determine the effect of specific hypnotic words on brain function using functional brain imaging. All women will have a pre-existing diagnosis of BPS/IC and their baseline pain prior to therapy and novel (arterial spin labeling) and more traditional (BOLD fMRI) neuroimaging techniques will be collected. Women in the hypnosis group will undergo treatment with three in-person hypnotherapy sessions in addition to a mobile web-based hypnosis application. Women in the usual care group will continue their usual care for BPS/IC. Subjects in both groups will complete a variety of questionnaires on bladder pain, urinary symptoms, sleep, mood, affect, disability, and sexual function before and after treatment. The first follow up visit will occur at the end of treatment (4 weeks after randomization). A select group of patients who are eligible to undergo neuroimaging will be invited to participate in neuroimaging after the first follow up visit. Data will also be collected at a second follow up visit at 2 months after randomization.

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2019-10-03
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis	Hypnosis	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
Improvement in bladder pain self-efficacy as measured by the Female Genitourinary Pain Index	3 months	This index is a well validated and widely used instrument for measuring pain in women with BPS/IC

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States