Status:
COMPLETED
Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
Lead Sponsor:
TriHealth Inc.
Conditions:
Female Patients With High Tone Pelvic Floor Dysfunction
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 op...
Eligibility Criteria
Inclusion
- candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
- aged 18-65
- high tone pelvic floor dysfunction
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01233791
Start Date
November 1 2010
End Date
December 1 2011
Last Update
July 10 2015
Active Locations (1)
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1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220