Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Female Patients With High Tone Pelvic Floor Dysfunction
• Intervention / Treatment: Drug: Vaginal Diazepam Suppository; Drug: Placebo Suppository

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Diazepam Suppository; Patients in this arm will be asked to use one vaginal suppository every night for 28 days	Drug: Vaginal Diazepam Suppository; 10mg compounded vaginal suppository
Placebo Comparator: Vaginal Placebo Suppository; Patients will be asked to use one vaginal suppository every night for 28 days	Drug: Placebo Suppository; Patients will be asked to use one vaginal suppository every night for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface EMG	A baseline sEMG will be compared to sEMG after 28 days of treatment.	After 28 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface EMG Midpoint	A baseline sEMG will be compared to sEMG after 14 days of treatment.	14 days after treatment
FSFI	Baseline FSFI scores will be compared to scores after 4 weeks of treatment to asses sexual function	28 days
VAS	Visual analog scale for pain will be collected at baseline and compared to VAS after 28 days of treatment	28 days
SF-12	baseline SF-12 scores will be compared to SF-12 scores after 28 days of treatment to asses quality of life in the two domains of mental and physical well-being.	28 days
PGI-I	Patient Global Impression of Improvement will be asked after 28 days of treatment to determine if the patient felt the treatment was helpful	28 days
PGI-S	Patient Global Impression of Severity will be collected and compared to determine how severe teh patient perceived their condition to be before and after treatment	28 days

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Catrina C Crisp, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: high tone pelvic floor dysfunction; levator pain; dyspareunia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: 10025-10-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No