Vaginal Diazepam for the Treatment of Female Pelvic Pain

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01938092

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders Pelvic Pain	Drug: Diazepam Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Diazepam Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.	Drug: Diazepam Other Names: Valium
Placebo Comparator: Placebo Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Diazepam

Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.

Drug: Diazepam

Other Names:

Valium

Placebo Comparator: Placebo

Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.