Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04635345 |
Other study ID # |
278027 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 11, 2021 |
Est. completion date |
August 2024 |
Study information
Verified date |
August 2023 |
Source |
Barts & The London NHS Trust |
Contact |
Jessica Gaddie, MbCHb, BSc |
Phone |
0207 377 7315 |
Email |
j.gaddie1[@]nhs.net |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The acceptability of vulvar vibration therapy has been evaluated in women with vulvodynia,
and found to be acceptable, however has not been assessed in women with a primary complaint
of vaginismus.
This proposed study looks at the feasibility and acceptability of using clitoral vibration
therapy, alongside current therapy, for women with vaginismus. It is likely that many, if not
most, of these women will also have an element of vulvodynia. The investigators propose that
the use of external clitoral or vulval vibration therapy is likely to be acceptable in most
women with vaginismus, based on acceptability of vulvar vibration therapy in women with
vulvodynia.
It is proposed that vibrator therapy may help women with female sexual dysfunction to use
vaginal dilators.
Description:
This is a nonrandomized controlled trial, with the initial cluster of patients receiving
standard therapy, and the second cluster receiving standard therapy plus vibrator.
Recruitment will be an initial 15 participants who will receive standard therapy, and then
another 15 who will receive an external vibrator.
This study will take place over approximately 12 months. Enrollment of patients will be from
a joint psychosexual clinic led by a medical doctor and a clinical psychologist. Female
patients are referred to this clinic by General Practitioners, from within the Sexual Health
service, or via Gynaecologists, frequently with complaint of difficulty or pain with
penetrative sex. Exclusion criteria will be: patients unable/ unwilling to consent,
transgender male or on testosterone therapy, unable to understand written and/or verbal
English, current dermtatological skin conditions requiring active treatment, genital herpes
simplex virus within 3 months, or not reporting symptoms of vaginismus with no evidence of
vaginismus on clinical examination.
Trial information will be given at the initial appointment. If the patient wishes to enrol,
than an initial baseline questionnaire will be given, and a follow up questionnaire will be
filled out by phone contact at 3-4 months afterward the initial consultation at the patients
consent.