Local delivery of cannabidiol in patients with vestibulodynia
| ISRCTN | ISRCTN74077970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74077970 |
| Secondary identifying numbers | SDSM-2021-01.1 |
- Submission date
- 10/08/2022
- Registration date
- 11/09/2022
- Last edited
- 30/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Vulvodynia is a highly prevalent form of chronic genital pain in women and vestibulodynia is the prevalent subtype in which the pain is localized at the entry of vagina. The disease is related to nerve fibre inflammation. The aim of this study is to measure the effectiveness and safety of cannabidiol delivered using vestibular electroporation in patients with vestibulodynia. Cannabidiol has demonstrated significant pain-relieving, anti-inflammatory, and anti-neuropathic activities without the psychoactive effect. Electroporation is a painless technique to deliver drugs through microelectrical stimulation.
Who can participate?
Patients aged 18 years and over affected by vestibulodynia
What does the study involve?
Participants are randomly allocated to one of two groups:
Active group: patients will receive one treatment cycle of transmucosal delivery of cannabidiol (3 ml CBD 8% gel) using vestibular electroporation for six treatments total, once a week. This is followed by follow-up visits at 4 and 8 weeks.
Non-active group: patients in the placebo group will receive one treatment cycle of transmucosal delivery of placebo gel 3 ml using vestibular electroporation once a week for up to 6 weeks. This is followed by follow-up visits at 4 and 8 weeks.
What are the possible benefits and risks of participating?
The treatment may reduce or resolve the symptoms related to vestibulodynia (vulvar pain and/or pain at sexual intercourse). The researchers are not aware of adverse events related to the treatment.
Where is the study run from?
Ospedale dei Bambini Vittore Buzzi (Italy)
When is the study starting and how long is it expected to run for?
May 2022 to June 2023
Who is funding the study?
Associazione Italiana Vulvodinia (Italy)
Who is the main contact?
Prof. Filippo Murina, filippo.murina@unimi.it
Contact information
Principal Investigator
via Castelvetro 22
Milano
20154
Italy
| Phone | +39 (0)2 63635420 |
|---|---|
| filippo.murina@unimi.it |
Study information
| Study design | Single-center interventional double-blinded randomized prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Transmucosal delivery of cannabidiol using vestibular electroporation in patients with vestibulodynia: a randomized, blinded prospective trial |
| Study acronym | DECANVBD |
| Study hypothesis | To prospectively document the efficacy and safety of transmucosal delivery of cannabidiol using vestibular electroporation in patients with vestibolodynia in order to reduce dyspareunia and vulvar burning/pain |
| Ethics approval(s) | Approval pending, Buzzi Hospital Ethics Committee |
| Condition | Vulvodynia |
| Intervention | Randomization is determined by a computer-generated number list (MedCalc Version 20.110). Active group: patients will receive one treatment cycle of transmucosal delivery of cannabidiol (3 ml CBD 8% gel) using vestibular electroporation for six treatments total, once a week. This is followed by follow-up visits at 4 and 8 weeks. Non-active group: patients in the placebo group will receive one treatment cycle of transmucosal delivery of placebo gel 3 ml using vestibular electroporation once a week for up to 6 weeks. This is followed by follow-up visits at 4 and 8 weeks |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Symptoms evaluated at baseline, 4 weeks and 8 weeks after treatment using: 1. 0-10 point visual scale (VAS) related to vulvar burning/pain and dyspareunia 2. Vestibular cotton swab test (small cotton-tipped applicator lightly rolled over the surfaces of the vestibule (mean of values at the 1, 3, 5, 6, 7, 9, and 11 o’clock locations by asking the subject to report pain intensity on a discrete visual analog scale of 1 (no pain) to 10 (worst possible pain). 3. Validated instruments: Female Sexual Function Index (FSFI), Vulvar Pain Functional Questionnaire (V-Q) |
| Secondary outcome measures | Evaluation of current perception threshold (CPT) testing (a technique which quantifies the sensitivity of vestibular nerve fibers) and vaginal EMG measurements, collected at states of rest and during several pelvic floor exercises through an EMG device with a vaginal sensor (Myotonus plus©-London-UK). The CPT values will be measured using the Neurometer CPT/C electrodiagnostic neurostimulator (Neurotron, Inc., Baltimore, MD), and vulvar vestibule CPT values will be determined using a G-trode Vaginal/ Rectal Electrode (Neurotron, Inc., Baltimore, MD). Measured at baseline, 4 weeks and 8 weeks follow-up visits. |
| Overall study start date | 01/05/2022 |
| Overall study end date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 60 total, 30 patients active treatment, 30 patients control arm |
| Participant inclusion criteria | 1. Women at least 18 years of age and before the menopause 2. Experience moderate to severe pain (minimum of 5/10 on a numerical rating scale in at least 90 % of attempted sexual intercourse) 3. Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding) 4. Presence of VBD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by a staff gynecologist 5. Have a stable sexual partner (sexual activity should include some attempted vaginal penetrations to evaluate pain intensity) 6. Subject is willing to attempt sexual activity between visits 7. Read and signed informed consent |
| Participant exclusion criteria | 1. Active vulvovaginal infections at the time of their gynecological examination 2. Genital bleeding of unknown origin 3. Patients concomitantly included in different interventional clinical trials 4. Unwillingness to provide informed consent |
| Recruitment start date | 01/06/2022 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Castelvetro 22
Milano
20154
Italy
Sponsor information
Hospital/treatment centre
Via Castelvetro 22
Milan
20154
Italy
| Phone | +39 (0)250042000 |
|---|---|
| info@vulvodinia.org | |
| Website | https://ospedaledeibambini.it/noi-e-il-buzzi/ |
"ROR" |
https://ror.org/044ycg712 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
30/08/2022: Trial's existence confirmed by the Ospedale dei Bambini Vittore Buzzi.
