Clinical Trial: Vaginal Diazepam for the Treatment of Female Pelvic Pain

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: University of Missouri-Columbia

Current Primary Outcome: 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 ]

Ten centimeter linear scale where patients mark their self-perceived level of pain. The change in pain from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.


Original Primary Outcome: Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks. [ Time Frame: Inital visit, 4 weeks, 12 weeks, 24 weeks ]

Ten centimeter linear scale where patients mark their self-perceived level of pain. The change in pain from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.


Current Secondary Outcome:

  • 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 ]
    The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The change in PFDI-20 score from the initial visit will be measured at 4 weeks, 12 weeks, and 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. ]
    Used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. It asks the participant what the pain feels like, how it changes with time, and how strong it is. The change in symptoms from baseline measured by this questionnaire will be measured at 4 weeks, 12 weeks ,and 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 ]
    Used to evaluate patients' perceptions of treatment effectiveness. The change in the GRA from from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.


Original Secondary Outcome: Same as current

Information By: University of Missouri-Columbia

Dates:
Date Received: August 30, 2013
Date Started: September 2013
Date Completion: June 2017
Last Updated: August 3, 2016
Last Verified: August 2016