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

Not Applicable

Completed

Interventions: Other: Standard care
Other: External Vibrator - patient-administered.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Dilator/standard therapy	Standard care	Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).
Vibrator Therapy + dilator/standard therapy	Standard care	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.
Vibrator Therapy + dilator/standard therapy	External Vibrator - patient-administered.	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.

Primary Outcome Measures

Name	Time	Method
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?	12-18 months	Qualitative questionnaire

Secondary Outcome Measures

Name	Time	Method
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?	12-24 months	Qualitative questionnaire
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?	12-24 months	Questionnaire - FSDS (above)
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?	12-24 months	Questionnaire - FSFI (above)