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Hypnosis for Bladder Pain Syndrome

Primary Purpose

Bladder Pain Syndrome, Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Standard of Care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypnosis

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 3, 2019
Last Updated
February 16, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04010513
Brief Title
Hypnosis for Bladder Pain Syndrome
Official Title
A Pilot to Determine the Feasibility of a Hypnosis Intervention for the Treatment of Bladder Pain Syndrome / Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Pain Syndrome, Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Women in the usual care group will continue their usual care for BPS/IC as dictated by their physicians.
Primary Outcome Measure Information:
Title
Improvement in bladder pain self-efficacy as measured by the Female Genitourinary Pain Index
Description
This index is a well validated and widely used instrument for measuring pain in women with BPS/IC
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female recruitment only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hypnosis for Bladder Pain Syndrome

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