Completed

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

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What is being tested

Vaginal Diazepam Suppository

+ Placebo Suppository

Drug
Who is being recruted

Urogenital Diseases+8

+ Genital Diseases

+ Mental Disorders

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: November 2010
See protocol details

Summary

Principal SponsorTriHealth Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2010

Actual date on which the first participant was enrolled.

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 TitleDiazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
NCT01233791
Principal SponsorTriHealth Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesMental DisordersDyspareuniaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate
candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH

aged 18-65

high tone pelvic floor dysfunction

7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients in this arm will be asked to use one vaginal suppository every night for 28 days

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Good Samaritan Hospital

Cincinnati, United StatesOpen Good Samaritan Hospital in Google Maps
CompletedOne Study Center