Vaginal Diazepam for the Treatment of Female Pelvic Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pelvic Floor Disorders Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Diazepam

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

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Diazepam

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Valium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No