Hypnosis for Bladder Pain Syndrome

NCT04010513 | Completed

• 1 other identifier: 832895
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Pain Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hypnosis

EXPERIMENTAL

Behavioral: Hypnosis

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Hypnosis BEHAVIORAL

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.

Hypnosis

Standard of Care OTHER

Women in the usual care group will continue their usual care for BPS/IC as dictated by their physicians.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female recruitment only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Hypnosis; Standard of Care

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: October 3, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)