Clinical trial NCT04635345: Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginismus
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Able and willing to give informed consent (additional measures have to be in place if children, vulnerable adults or adults unable to give consent are included)
* Female
* Over the age of 18
* With symptoms and clinical signs consistent with vaginismus/ vaginismus and vulvodynia.

Exclusion Criteria:

* Unwilling or unable to give consent
* Transgender male / on testosterone therapy
* Inability to understand written and / or verbal English
* Current dermatological skin conditions requiring active treatment
* Genital herpes simplex virus symptoms within preceding 3 months
* Not reporting symptoms of vaginismus, and no evidence of vaginismus on clinical examination.

Primary outcomes:
measure: Is vibration therapy (through the use of handheld external vibrators on clitoral and vulval area) acceptable to women as part of medical management of vaginismus and vaginismus/vulvodynia, alongside current medical management?
timeFrame: 12-18 months
Secondary outcomes:
measure: Does the use of clitoral/ vulval vibrators help women to progress more easily with the use of vaginal dilators compared to women not using these?
timeFrame: 12-24 months
measure: Is there any self-reported difference in experiences of pleasure or enjoyment around sexual experiences in the two groups of women as reported by FSDS (Female Sexual Distress Scale) Scores?
timeFrame: 12-24 months
measure: Is there any self-reported difference in experiences of pleasure or enjoyment around sexual experiences in the two groups of women as reported by FSFI (Female Sexual Function Index) Scores?
timeFrame: 12-24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ambrose King Sexual Health Centre
Study officials:
affiliation: Barts & The London NHS Trust
name: Jess Gaddie
role: PRINCIPAL_INVESTIGATOR
References: