Overview

This trial is active, not recruiting.

Conditions pelvic floor disorders, pelvic pain
Treatments diazepam, placebo
Phase phase 2
Sponsor University of Missouri-Columbia
Start date September 2013
End date June 2017
Trial size 37 participants
Trial identifier NCT01938092, 1208827

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
diazepam Valium
(Placebo Comparator)
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
placebo

Primary Outcomes

Measure
Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks.
time frame: Initial visit, 4 weeks, 12 weeks, 24 weeks

Secondary Outcomes

Measure
Change from baseline in Pelvic Floor Distress Inventory-20 Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.
time frame: Initial visit, 4 weeks, 12 weeks, 24 weeks
Change from baseline in McGill Pain Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.
time frame: Initial visit, 4 weeks, 12 weeks, 24 weeks.
Change from baseline in Global Response Assessment score at 4 weeks, 12 weeks, and 24 weeks.
time frame: Initial visit, 4 weeks, 12 weeks, 24 weeks

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial
Principal investigator Raymond T Foster, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Missouri-Columbia.