Vaginal Diazepam for the Treatment of Female Pelvic Pain

Raymond Foster

Status and phase

Completed

Phase 2

Conditions

Pelvic Floor Disorders

Pelvic Pain

Treatments

Drug: Placebo

Drug: Diazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT01938092

1208827

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.