Skip to main content
OpenTrials
Completed

NCT Number: NCT01233791

Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Patients With High Tone Pelvic Floor Dysfunction Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal Diazepam Suppository

Drug

10mg compounded vaginal suppository

Placebo suppository

Drug

Patients will be asked to use one vaginal suppository every night for 28 days

Primary outcomes

  1. Surface EMG

    Time frame: After 28 days of treatment

    A baseline sEMG will be compared to sEMG after 28 days of treatment.

Secondary outcomes

  1. Surface EMG Midpoint

    Time frame: 14 days after treatment

    A baseline sEMG will be compared to sEMG after 14 days of treatment.

  2. FSFI

    Time frame: 28 days

    Baseline FSFI scores will be compared to scores after 4 weeks of treatment to asses sexual function

  3. VAS

    Time frame: 28 days

    Visual analog scale for pain will be collected at baseline and compared to VAS after 28 days of treatment

  4. SF-12

    Time frame: 28 days

    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.

  5. PGI-I

    Time frame: 28 days

    Patient Global Impression of Improvement will be asked after 28 days of treatment to determine if the patient felt the treatment was helpful

  6. PGI-S

    Time frame: 28 days

    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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.