Clinical trial NCT01938092: Vaginal Diazepam for the Treatment of Female Pelvic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Floor Disorders
Pelvic Pain
Keywords: High-tone pelvic floor dysfunction
Spasm
Pelvic pain
Diazepam
Female
Randomized trial
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.
timeFrame: 4 weeks
measure: McGill Pain Questionnaire Score (PRI) at 4 Weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Raymond T Foster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holland MA, Joyce JS, Brennaman LM, Drobnis EZ, Starr JA, Foster RT Sr. Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2019 Jan/Feb;25(1):76-81. doi: 10.1097/SPV.0000000000000514.