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Pilot Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With Interstitial Cystitis

Phase 2
18 Years
Not Enrolling
Interstitial Cystitis, Pelvic Pain

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Trial Information

Pilot Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With Interstitial Cystitis

This is a randomized pilot study. Women who are referred to the Nurse Practitioner for
treatment will be invited to enroll. If the patient meets the study criteria, the study will
be explained. If the patient agrees to participate in this study, informed consent will be
obtained. The patient will be randomized (similar to flipping a coin) into either the
Treatment group or Control group. Both groups will be maintained with their IC regimens as
prescribed by their own health care providers. The following actions and treatment will

There will be 2 visits for all subjects. All subjects will complete a pain diary and
medication log during the study. Salivary samples will be obtained at baseline, during the
first week of the study, after the 2nd week of the study, the midpoint of the intervention
(week 3) and at the end of the study. The Treatment group will listen to a guided imagery CD
twice a day, and the Control group will sit or lay down, doing whatever they choose, for the
same length of time twice a day. All subjects will complete questionnaires upon enrollment
and at week 6.The "Treatment" subjects will receive the guided imagery CD specific for
pelvic pain and interstitial cystitis. After the baseline data is completed, they will
listen to track 2 of the CD (25 min. in length) twice a day ("Relaxation Exercise A"). The
first week they listen to the CD, for 3 days they will obtain salivary tests upon waking
then ½ hour later. Then they will listen to the CD, and obtain another salivary sample in
addition to recording their pulse and respirations immediately after listening to the CD.
The bedtime salivary test, pulse and respirations will be done immediately after listening
to the CD. Salivary testing, pulse and respirations will also be done before this evening CD
session. The salivary testing will be repeated in the same fashion during the 3rd week of

Inclusion Criteria:

- Established diagnosed IC patient

- Women at least 18 years of age

- Self reported pelvic pain

- Capable of giving informed consent

- Capable and willing to follow all study related procedures (e.g. keep voiding diary,
pain diary, complete questionnaires, listening to CD, obtaining salivary samples).

- Participants must have a stable medication regimen.

- Neuromodulation (if present) must stay stable throughout the study.

Exclusion Criteria:

- Currently participating or have participated within the past 30 days in any clinical
investigation involving or impacting urinary or renal function. Patients with
neuromodulation devices are excluded for the first 3 months after insertion of the

- Use of this guided imagery CD within the past 30 days.

- Diagnosed depression

- Pregnancy or intending to become pregnant during the study

- Cannot independently comprehend and complete the questionnaires.

- The subject is deemed unsuitable for enrollment in this study by the investigators
based on their history.

- Men are excluded

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Improvement of IC symptoms. Overall improvement will be quantified by a Global Response Assessment.

Principal Investigator

Kenneth Peters, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

William Beaumont Hospitals


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

December 2007

Related Keywords:

  • Interstitial Cystitis
  • Pelvic Pain
  • Interstitial Cystitis
  • Pelvic pain
  • Guided Imagery
  • Cystitis
  • Pelvic Pain
  • Cystitis, Interstitial



William Beaumont HospitalRoyal Oak, Michigan  48073