Vaginal diazepam plus Transcutaneous Electrical Nerve Stimulation: a powerful synergy to treat vestibulodynia

Completed

• Conditions: Vestibulodynia, localised provoked vulvodynia at the vestibule; Urological and Genital Diseases

• Registration Number: ISRCTN76957838
• Lead Sponsor: Italian Vulvodynia Association (Associazione Italiana Vulvodinia)

Brief Summary

1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29960200 (added 29/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-24
• Study Completion: 2016-09-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosis of Vestibulodynia (VBD)
2. At least 18 years of age
3. Diagnosed with moderate or severe pelvic floor tone hypertonic disfunction

Exclusion Criteria

1. Allergy to diazepam or any benzodiazepine
2. Currently pregnant
3. Have any contraindication to diazepam

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Pain modification, assessed using VAS and Dispareunya score<br><br> Measured from baseline to 60 days<br>

Secondary Outcome Measures

Name	Time	Method
Modification of pelvic floor muscle measurements, via assessment of variation in pelvic floor muscles parameters and vestibular nerve fibers current perception threshold