Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635345
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-08-03
Brief Title:
Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus Vibrator Therapy and Dilators in Vaginismus
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
A Pilot Study Assessing the Feasibility of Using Clitoral Vibrators to Aid Vaginal Dilator Therapy in Women Presenting to Psychosexual Services With Vaginismus
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViTaDiVa
Brief 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
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
Detailed 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None