NCT00420550

Brief Summary

Interstitial cystitis (IC) affects more than one million women in the United States. It has been thought that IC patients who have been unable to obtain adequate relief from medical remedies would value a psychotherapeutic intervention that could diminish some of their pain. There are currently no studies using biomarkers with the use of a relaxation technique called guided imagery in IC patients. Many guided imagery intervention studies in areas such as cancer, post-operative pain, and arthritis reported that guided imagery resulted in improvements in the psychological or physiological outcomes examined. If this is also true in IC patients, this intervention may prevent the use of unnecessary medications and procedures that are currently being used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

January 9, 2007

Last Update Submit

March 19, 2012

Conditions

Interstitial CystitisPelvic Pain

Keywords

Interstitial CystitisPelvic painGuided Imagery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Bladder symptoms will be assessed by completion of a voiding diary and the Interstitial Cystitis Symptom Index and Problem Index (IC-SIPI) (36) pre- and post- study intervention.

  • Pain will be measured by a Visual Analog Scale (VAS)

  • The Relaxation Response will be evaluated by salivary cortisol, alpha amylase and IL-6 levels (all biomarkers), pulse, and respiratory rate.d.) Overall health and well-being will be assessed by the SF-12 (37).

Interventions

Relaxation Response using Guided ImageryBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 device.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (2)

  • Kusek JW, Nyberg LM. The epidemiology of interstitial cystitis: is it time to expand our definition? Urology. 2001 Jun;57(6 Suppl 1):95-9. doi: 10.1016/s0090-4295(01)01141-4.

    PMID: 11378056BACKGROUND

  • Myers DL, Aguilar VC. Gynecologic manifestations of interstitial cystitis. Clin Obstet Gynecol. 2002 Mar;45(1):233-41. doi: 10.1097/00003081-200203000-00024. No abstract available.

    PMID: 11862075BACKGROUND

MeSH Terms

Conditions

Cystitis, InterstitialPelvic Pain

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Peters, M.D.

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

US(1)