Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

Study Overview
=================
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.

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

Conditions
-----------------
Female Patients With High Tone Pelvic Floor Dysfunction

Intervention / Treatment
-----------------
* Drug: Vaginal Diazepam Suppository
* Drug: Placebo Suppository


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high tone pelvic floor dysfunction, levator pain, dyspareunia