Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Patients With High Tone Pelvic Floor Dysfunction
Intervention: Vaginal Diazepam Suppository (Drug); Placebo Suppository (Drug)
Phase: N/A
Status: Completed
Sponsored by: TriHealth Inc. Official(s) and/or principal investigator(s): Catrina C Crisp, MD, Principal Investigator, Affiliation: TriHealth Inc.
Summary
The purpose of this study is to determine whether vaginal diazepam suppositories are an
effective treatment of high tone pelvic floor dysfunction.
Clinical Details
Official title: Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Surface EMG
Secondary outcome: Surface EMG MidpointFSFI VAS SF-12 PGI-I PGI-S
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Good Samaritan Hospital, Cincinnati, Ohio 45220, United States
Additional Information
Starting date: November 2010
Last updated: July 9, 2015
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