Hypnosis for Bladder Pain Syndrome

A Pilot to Determine the Feasibility of a Hypnosis Intervention for the Treatment of Bladder Pain Syndrome / Interstitial Cystitis

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Intervention / Treatment: Behavioral: Hypnosis; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Other: Standard of Care; Women in the usual care group will continue their usual care for BPS/IC as dictated by their physicians.
Experimental: Hypnosis	Behavioral: Hypnosis; Women in the hypnosis group will undergo treatment with three in-person hypnosis sessions and will be given access to hypnosis web-app for at home practice.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Somatoform Disorders; Cystitis, Interstitial
• Other Study ID Numbers: 832895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No