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Completed

NCT Number: NCT04635345

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

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.

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Key information

Conditions

Vaginismus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vaginal Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ambrose King Sexual Health Centre

London, E1 2BB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External Vibrator - patient-administered.

Other

Patient provided with external vibrator for self-use, as well as vaginal dilators.

Standard care

Other

Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.

Primary outcomes

  1. 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?

    Time frame: Follow up was over 6-24 months following initial contact. This allowed for any therapy including group therapy to be completed. Mean from initial to follow up was 10 months for intervention group and 11.5 months for control group.

    A 5-point Likert scale was used. Respondents replied to statements 'Overall I found using the (dilators/vibrator) acceptable" 1=not at all 2=a little 3=neither yes or no 4=mostly 5=completely. Intervention group mean scores listed in table. A higher score indicates increased acceptability.

    Acceptability of vibrators could not be assessed in the dilator/standard therapy group, because this group did not receive vibrators.

Secondary outcomes

  1. 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?

    Time frame: Follow up was over 6-24 months following initial contact. This allowed for any therapy including group therapy to be completed. Mean from initial to follow up was 10 months for intervention group and 11.5 months for control group.

    Respondents were asked to respond to statements with another 5-point Likert scale. 1=Not at all 2=not really 3=yes to some extent 4=agree 5=strongly agree. A higher score indicates a more positive outcome. In response to the statement 'the dilators have helped me manage my symptoms' those who 'agreed to some extent', 'agreed' or 'strongly agreed', numbers are listed in table.

  2. 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?

    Time frame: Follow up was over 6-24 months following initial contact. This allowed for any therapy including group therapy to be completed. Mean from initial to follow up was 10 months for intervention group and 11.5 months for control group.

    The Female Sexual Distress Scale or FSDS is a 13-item questionnaire designed to measure sexually related personal distress, including the psychological impact of sexual dysfunction, and feelings of anger, frustration, worry related to sex. A higher score indicates more severe sexual dysfunction. The scale has a minimum score of 0 and maximum of 52.

  3. 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?

    Time frame: Follow up was over 6-24 months following initial contact. This allowed for any therapy including group therapy to be completed. Mean from initial to follow up was 10 months for intervention group and 11.5 months for control group.

    A score of below 26.55 on the Female Sexual Function Index indicates Female Sexual Dysfunction. A lower score indicates greater sexual dysfunction. The minimum score is 2 and the maximum is 36. The FSFI is a 19-item questionnaire which uses 5-point Likert scales to investigate different domains of desire, arousal, lubrication, orgasm, satisfaction and pain. FSFI gives a score out of 36 with severe FSD (2-7.2), moderate (7.3-14.4), mild to moderate (14.5-21.6), mild (21.7-28.1) and no FSD (28.2-36). Each domain is weighted, resulting in an overall score of sexual function but can also be analysed separately.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

A Pilot Study Assessing the Feasibility of Using Clitoral Vibrators to Aid Vaginal Dilator Therapy in Women Presenting to Psychosexual Services With Vaginismus.

Acronym: ViTaDiVa

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2020
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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