Feasibility of use of vibrators with vaginal dilators for vaginismus

  • Research type

    Research Study

  • Full title

    A controlled pilot study assessing the feasibility of using clitoral vibrators to aid vaginal dilator therapy in women presenting to psychosexual services with vaginismus.

  • IRAS ID

    278027

  • Contact name

    Jessica Gaddie

  • Contact email

    j.gaddie1@nhs.net

  • Sponsor organisation

    Barts Health NHS Trust

  • Clinicaltrials.gov Identifier

    NCT04635345

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    VITA DIVA- Vibration Therapy And Dilators for Vaginismus

    Vaginismus is the involuntary spasm of the pelvic floor muscles which surround the vaginal wall. This can make sexual intercourse uncomfortable, painful, or impossible, and can have resultant impacts on a woman’s sexual pleasure and ability to conceive. Successful treatment relies often on both medical and psychosocial interventions alongside self-help and practice. Current medical therapy for vaginismus often consists of the use of topical local anaesthetic gel, often in addition to oral medications such as low dose Tricyclic Antidepressants together with recommendation of progressive vaginal dilator therapy and physiotherapy.

    Anecdotally, some women find that clitoral stimulation can sometimes have a positive impact on the ability to progress with vaginal dilator treatment, but this has not yet been evaluated in a research setting. This study looks at the feasibility and acceptability of using clitoral vibration therapy, alongside current therapy, for women with Vaginismus.

    It is proposed that the use of external clitoral or vulval vibration therapy is likely to be acceptable in most women with vaginismus and may help with progression of vaginal dilator therapy in some women.
    Recruitment of an initial 10-15 participants, who will receive standard therapy with vaginal dilators, and another 10-20 who will receive dilators and an external vibrator. This will take place over 6-12 months in a joint psychosexual clinic which is run by a medical doctor and a clinical psychologist. 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 afterwards at the patients consent.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    21/LO/0323

  • Date of REC Opinion

    27 May 2021

  • REC opinion

    Further Information Favourable Opinion