Clinical trial NCT01233791: Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
Official title: Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Patients With High Tone Pelvic Floor Dysfunction
Keywords: high tone pelvic floor dysfunction
levator pain
dyspareunia
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.

Detailed description: High tone pelvic floor dysfunction is a common cause of pelvic pain in females. It is thought to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently, treatment options include warm baths, stretching, physical therapy with myofascial therapy or biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy can be effective. However, it usually involves frequent visits to a specialized physical therapist to undergo intravaginal treatments consisting of myofascial release, massage, or biofeedback. We would like to find a treatment option for patients that would be effective without the invasive and time consuming nature of physical therapy. It is known that diazepam is a valid treatment option for disorders involving spasticity including spastic cerebral palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review, and the results are confounded by concurrent physical therapy. They were, however, able to find that patients treated with diazepam suppositories showed a significant improvement in pelvic floor tone. They also assessed pain and sexual function, but these did not reach statistical significance.

Eligibility criteria: Inclusion Criteria:

* candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
* aged 18-65
* high tone pelvic floor dysfunction

Exclusion Criteria:

* allergy to diazepam or any drug in the class of benzodiazepines
* current pelvic floor physical therapy
* pelvic surgery within the last 3 months
* current pregnancy, planning on pregnancy during the study period, or not sure if pregnant
* regular benzodiazepine, muscle relaxant, or daily alcohol use
* history of alcohol or drug abuse
* contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute narrow angle glaucoma, severe respiratory insufficiency, sleep apnea

Primary outcomes:
measure: Surface EMG
timeFrame: After 28 days of treatment
Secondary outcomes:
measure: Surface EMG Midpoint
timeFrame: 14 days after treatment
measure: FSFI
timeFrame: 28 days
measure: VAS
timeFrame: 28 days
measure: SF-12
timeFrame: 28 days
measure: PGI-I
timeFrame: 28 days
measure: PGI-S
timeFrame: 28 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina C Crisp, MD
role: PRINCIPAL_INVESTIGATOR
References: