Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus) (ViTaDiVa)

Barts & The London NHS Trust

Status: Completed

Conditions: Vaginismus

Treatments: Other: External Vibrator - patient-administered.; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04635345

278027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Vibrator Therapy + dilator/standard therapy

Experimental group

Description:

Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel) plus an external vibrator.

Treatment:

Other: Standard care

Other: External Vibrator - patient-administered.

Dilator/standard therapy

Active Comparator group

Description:

Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).

Treatment:

Other: Standard care