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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 Midpoint

FSFI

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

Page last updated: August 23, 2015

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