Condition category
Urological and Genital Diseases
Date applied
13/08/2016
Date assigned
24/08/2016
Last edited
24/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vulvodynia is a persistent, unexplained pain in the vulva (the skin around the entrance to the vagina). Symptoms include a burning or stinging pain that can be triggered by touch, for example when having sex or using a tampon. It may be focused on part of the vulva or be more widespread, with pain in the buttocks and inner things. It often occurs in women that are otherwise healthy.
Pelvic floor muscle dysfunction (for example, abnormal tightening of the muscles) is present in a significant number of women with vulvodynia. It is possible that there is a link between increased mucosal sensitivity (sensitivity of the inner lining of the vagina) and the underlying muscles leading to compensatory contracture (muscle contraction) and hypertonicity (muscle spasms). This may result in pain. Conversely, underlying pelvic floor muscles dysfunction may lead to mucosal sensitivity. Transcutaneous electrical nerve stimulation (TENS) can be used to treat pain. This treatment involves using a machine to deliver a mild electrical current to the painful area. Diazepam is a drug known to treat muscle spasms. The aim of this study is to combine the use of TENS with diazepam inserted into the vagina to treat vulvodynia.

Who can participate?
Adult women with Vulvodynia.

What does the study involve?
Patients are randomly and assigned into one of two groups. Those in group 1 are given a diazepam vaginal tablet with instructions to insert one a day, before going to sleep, for the next 60 days. They also receive TENS therapy. Those in group 2 are given a dummy tablet with instructions to insert one a day, before going to sleep, for the next 60 days. They also receive TENS therapy. All patients are then assessed to see whether both their pain levels and pelvic floor muscle measurements have improved.

What are the possible benefits and risks of participating?
Possible benefits include pain relief and improvements in pelvic floor muscle dysfunction. No adverse side effects are expected.

Where is the study run from?
V. Buzzi Hospital-Milan (Italy)

When is the study starting and how long is it expected to run for?
March 2016 to September 2016

Who is funding the study?
Italian Vulvodynia Association

Who is the main contact?
Dr Filippo Murina
filippomurina@tin.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Filippo Murina

ORCID ID

http://orcid.org/0000-0002-9966-6448

Contact details

Via Tintoretto 9
Buccinasco
20090
Italy
+393386287765
filippomurina@tin.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICP-1345/2016

Study information

Scientific title

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

Acronym

Study hypothesis

The aim is to investigate the effectiveness of vaginal diazepam in addition to Transcutaneous Electrical Nerve Stimulation (TENS) on the treatment of vestibulodynia (VBD); we believe that the synergy of the effect of the two therapies as a multimodal treatment strategy, would improve both vulvar pain and pelvic floor muscle dysfunction.

Ethics approval

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

Study design

A double-blind placebo-controlled randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Vestibulodynia, localised provoked vulvodynia at the vestibule

Intervention

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 duration of 100 microseconds (second program). All patients received a supervised trial before using the TENS at home. The trial consisted in 6 to 7 sessions and served to familiarize the patient on use of TENS, while allowing the therapist to check that the patient was using the device properly. In the TENS treatment protocol, the pulse is increased rapidly until the patient reports the onset of any sensation under the electrodes. The intensity is then increased slowly until this sensation reaches a level described as the maximum tolerable, without experiencing pain. After completing the trial, the patient is consigned their TENS unit after verbal and written instruction, with a recommendation to perform home treatment 3 times each week.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Pain modification, assessed using VAS and Dispareunya score

Measured from baseline to 60 days

Secondary outcome measures

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

Overall trial start date

01/03/2016

Overall trial end date

01/09/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

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

Recruitment start date

01/03/2016

Recruitment end date

01/04/2016

Locations

Countries of recruitment

Italy, Jamaica

Trial participating centre

V. Buzzi Hospital-Milan
20124
Italy

Sponsor information

Organisation

Italian Vulvodynia Association (Associazione Italiana Vulvodinia)

Sponsor details

Via Pergolesi 4
Milano
20124
Italy
+390257995464
info@vulvodinia.org

Sponsor type

Charity

Website

www.vulvodinia.org

Funders

Funder type

Charity

Funder name

Italian Vulvodynia Association (Associazione Italiana Vulvodinia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/09/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes