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

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN76957838
• Date of registration: 24/08/2016
• Prospective Registration: No
• Primary sponsor: Italian Vulvodynia Association (Associazione Italiana Vulvodinia)
• Public title: Vaginal diazepam plus Transcutaneous Electrical Nerve Stimulation: a powerful synergy to treat vestibulodynia
• Scientific title: Vaginal diazepam plus Transcutaneous Electrical Nerve Stimulation - a powerful synergy to treat vestibulodynia: a randomized controlled trial
• Date of first enrolment: 01/03/2016
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN76957838
• Study type: Interventional
• Study design: A double-blind placebo-controlled randomised controlled study (Treatment)

Countries of recruitment

Italy, Jamaica

Contacts

• Name: Filippo Murina

Key inclusion & exclusion 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:
1. Allergy to diazepam or any benzodiazepine
2. Currently pregnant
3. Have any contraindication to diazepam


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 the manufacturer in separated boxes with the same color and they were random numbered, by staff not participating in the study, in a pharmacy outside the hospital. Investigators were blinded to the randomization code until all data were analyzed. The vaginal tablet containing equal parts of diazepam and placebo (cornstarch) were placed in plastic bags and randomly distribute to patients enrolled in the study. Both diazepam and placebo formulations used an identical lactose monohydrate and cellulose microcrystalline composition, commonly used for vaginal tablet and absorption of the base was previously evaluated optimal.

Before randomization, patients were asked to stop any topical or systemic therapy they were taking.
Treatment instructions were to insert one vaginal tablet daily, before going to sleep, for 60 days.
This time of administration was chosen to avoid any theoretical sedative effects from the diazepam.
All patients received TENS therapy in a self-administered domiciliary protocol. A dual channel portable TENS unit (NeuroTrac Continence; 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 probe (Periprobe VAG2ST Beac, Pavia, Italy), 20 mm in diameter and 110 mm in length, with two gold metallic transversal rings as electrodes. It was inserted into the vagina for 20 mm.

Two customized programs were set according to results from previous studies. The standard protocol for TENS was 15 minutes of 100-Hz frequency and pulse duration of 50 microseconds (first program), followed by 15 minutes of 5-Hz frequency and pulse durati

Primary Outcome(s)

Pain modification, assessed using VAS and Dispareunya score

Measured from baseline to 60 days

Secondary Outcome(s)

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

Secondary ID(s)

ICP-1345/2016

Source(s) of Monetary Support

Italian Vulvodynia Association (Associazione Italiana Vulvodinia)

Ethics review

Status:
Approval date:
Contact:

Institutional Review Board of V. Buzzi Milan (Italy), 30/10/2015, ref:.N. 1345/2016

Results

• Results available: Yes
• Date Completed: 01/09/2016