Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01233791
First received: November 2, 2010
Last updated: February 20, 2014
Last verified: February 2014

November 2, 2010
February 20, 2014
November 2010
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01233791 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Female Patients With High Tone Pelvic Floor Dysfunction
  • Drug: Vaginal Diazepam Suppository
    10mg compounded vaginal suppository
  • Drug: Placebo Suppository
    Patients will be asked to use one vaginal suppository every night for 28 days
  • Experimental: Vaginal Diazepam Suppository
    Patients in this arm will be asked to use one vaginal suppository every night for 28 days
    Intervention: Drug: Vaginal Diazepam Suppository
  • Placebo Comparator: Vaginal Placebo Suppository
    Patients will be asked to use one vaginal suppository every night for 28 days
    Intervention: Drug: Placebo Suppository
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233791
10025-10-021
Yes
TriHealth Inc.
TriHealth Inc.
Not Provided
Principal Investigator: Catrina C Crisp, MD TriHealth Inc.
TriHealth Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP