Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
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Purpose
The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.
| Condition | Intervention |
|---|---|
|
Female Patients With High Tone Pelvic Floor Dysfunction |
Drug: Vaginal Diazepam Suppository Drug: Placebo Suppository |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial. |
- Surface EMG [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: No ]A baseline sEMG will be compared to sEMG after 28 days of treatment.
- Surface EMG Midpoint [ Time Frame: 14 days after treatment ] [ Designated as safety issue: No ]A baseline sEMG will be compared to sEMG after 14 days of treatment.
- FSFI [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Baseline FSFI scores will be compared to scores after 4 weeks of treatment to asses sexual function
- VAS [ Time Frame: 28 days ] [ Designated as safety issue: No ]Visual analog scale for pain will be collected at baseline and compared to VAS after 28 days of treatment
- SF-12 [ Time Frame: 28 days ] [ Designated as safety issue: No ]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.
- PGI-I [ Time Frame: 28 days ] [ Designated as safety issue: No ]Patient Global Impression of Improvement will be asked after 28 days of treatment to determine if the patient felt the treatment was helpful
- PGI-S [ Time Frame: 28 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Catrina C Crisp, MD | 513-862-4171 | catrina_crisp@trihealth.com |
| United States, Ohio | |
| Good Samaritan Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Catrina C Crisp, MD 513-862-4171 catrina_crisp@trihealth.com | |
| Principal Investigator: Catrina C Crisp, MD | |
| Principal Investigator: | Catrina C Crisp, MD | TriHealth Inc. |
More Information
No publications provided
| Responsible Party: | Catrina C. Crisp Harmon, Urogynecologist, TriHealth Inc. |
| ClinicalTrials.gov Identifier: | NCT01233791 History of Changes |
| Other Study ID Numbers: | 10025-10-021 |
| Study First Received: | November 2, 2010 |
| Last Updated: | September 23, 2011 |
| Health Authority: | US: Institutional Review Board |
Keywords provided by TriHealth Inc.:
|
high tone pelvic floor dysfunction levator pain dyspareunia |
Additional relevant MeSH terms:
|
Diazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Muscle Relaxants, Central |
Neuromuscular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on June 17, 2013