Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

NCT ID: NCT01233791

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Female Patients With High Tone Pelvic Floor Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vaginal Diazepam Suppository

Patients in this arm will be asked to use one vaginal suppository every night for 28 days

Group Type: EXPERIMENTAL

Vaginal Diazepam Suppository

Intervention Type: DRUG

10mg compounded vaginal suppository

Vaginal Placebo Suppository

Patients will be asked to use one vaginal suppository every night for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo Suppository

Intervention Type: DRUG

Patients will be asked to use one vaginal suppository every night for 28 days

Interventions

Vaginal Diazepam Suppository

10mg compounded vaginal suppository

Intervention Type: DRUG

Placebo Suppository

Patients will be asked to use one vaginal suppository every night for 28 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catrina C Crisp, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Good Samaritan Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

10025-10-021

Identifier Type: -

Identifier Source: org_study_id