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The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Diazepam Suppository | Experimental | Patients in this arm will be asked to use one vaginal suppository every night for 28 days |
|
| Vaginal Placebo Suppository | Placebo Comparator | Patients will be asked to use one vaginal suppository every night for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Diazepam Suppository | Drug | 10mg compounded vaginal suppository |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surface EMG | A baseline sEMG will be compared to sEMG after 28 days of treatment. | After 28 days of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catrina C Crisp, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2015 | |
| Reset | Aug 19, 2015 | |
| Release | Oct 19, 2015 | |
| Unrelease | Yes | |
| Release | Oct 28, 2015 | |
| Reset | Dec 4, 2015 | |
| Release | Dec 19, 2016 | |
| Reset | Feb 9, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2015 | Aug 19, 2015 | |||
| Oct 19, 2015 |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo Suppository |
| Drug |
Patients will be asked to use one vaginal suppository every night for 28 days |
|
| 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 |
| Yes |
| Oct 28, 2015 | Dec 4, 2015 |
| Dec 19, 2016 | Feb 9, 2017 |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |