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Vaginal Diazepam for the Treatment of Female Pelvic Pain

Information source: University of Missouri-Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Floor Disorders; Pelvic Pain

Intervention: Diazepam (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Missouri-Columbia

Official(s) and/or principal investigator(s):
Raymond T Foster, MD, Principal Investigator, Affiliation: University of Missouri-Columbia

Overall contact:
Raymond Foster, MD, Phone: 573-817-3165, Email: FosterRT@health.missouri.edu

Summary

To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.

Clinical Details

Official title: Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks.

Secondary outcome:

Change from baseline in Pelvic Floor Distress Inventory-20 Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.

Change from baseline in McGill Pain Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.

Change from baseline in Global Response Assessment score at 4 weeks, 12 weeks, and 24 weeks.

Detailed description: Women who are asked to participate will already be receiving a standard conservative therapy consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and Kegel exercises. Participants will randomly be assigned by a computer-derived random number sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam) or the placebo group Investigators and patients will be blinded to group assignment. The placebo or diazepam tablet will be distributed to the participant in the examining room on the day of allocation. The participant will be instructed to insert the diazepam or placebo tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal tablet 1-2 times daily as needed in addition to the standard conservative therapy. The placebo group will receive the standard conservative therapy, and an intravaginal tablet (visually indistinguishable from diazepam) commercially produced by the university pharmacy. After 4 weeks, patients from either group will have the option of enrolling into a standard routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain Questionnaire and Global Response Assessment will be completed by the participant at the initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of choosing one or more methods for returning questionnaires: electronic mail, self-addressed home envelope, or telephone call.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age 18 years old

- Primary complaint of acute or chronic pelvic pain with or without dyspareunia

- Physical exam findings consistent with levator muscle spasm

- Capable of inserting tablet in vagina without use of applicator.

Exclusion Criteria:

- Chronic narcotic use

- Non-English speaking

- Currently serving a prison sentence

- Stage III or greater vaginal prolapse

- Allergies or contraindications to benzodiazepines

- Pregnant or breastfeeding

- Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal

valium therapy

- Unwilling or incapable of inserting tablet in vagina without applicator.

Locations and Contacts

Raymond Foster, MD, Phone: 573-817-3165, Email: FosterRT@health.missouri.edu

Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System, Columbia, Missouri 65201, United States; Recruiting
Raymond T Foster, MD, Phone: 573-817-3165, Email: FosterRT@health.missouri.edu
Additional Information

Starting date: September 2013
Last updated: December 8, 2014

Page last updated: August 23, 2015

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