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Hypnosis for Bladder Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010513
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Pain Syndrome Interstitial Cystitis Behavioral: Hypnosis Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot to Determine the Feasibility of a Hypnosis Intervention for the Treatment of Bladder Pain Syndrome / Interstitial Cystitis
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female recruitment only
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010513


Contacts
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Contact: Alex Soriano, MD 215-662-7727 alex.soriano@pennmedicine.upenn.edu
Contact: Lily Arya, MD LArya@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lily Arya, MD       larya@obgyn.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04010513    
Other Study ID Numbers: 832895
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases