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

Vaginal diazepam plus Transcutaneous Electrical Nerve Stimulation - a powerful synergy to treat vestibulodynia: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76957838
Enrollment
40
Registered
2016-08-24
Start date
2016-03-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibulodynia, localised provoked vulvodynia at the vestibule Urological and Genital Diseases

Interventions

Patients were randomly and blindly assigned into one of two groups to receive diazepam or placebo vaginal tablet. Identical vaginal tablet containing 5 mg of diazepam or placebo, were received from th
VerityMedical, London, UK) was used, which produces a symmetrical biphasic wave and has three customizable mode programs.The stimulationwas delivered through a commercially available plastic vaginal p

Sponsors

Italian Vulvodynia Association (Associazione Italiana Vulvodinia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain modification, assessed using VAS and Dispareunya score Measured from baseline to 60 days

Secondary

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

Countries

Italy, Jamaica

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026