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

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

Study Overview

• Status: Recruiting
• Conditions: Vaginismus
• Intervention / Treatment: Other: External Vibrator - patient-administered.; Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Gaddie, MbCHb, BSc; Phone Number: 0207 377 7315; Email: j.gaddie1@nhs.net
• Study Contact Backup: Name: Jill Zelin; Email: jill.zelin@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2BB
    • Recruiting
    • Ambrose King Sexual Health Centre
    • Contact: Jessica Gaddie, MBChB; Email: j.gaddie1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibrator Therapy + dilator/standard therapy; 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.	Other: External Vibrator - patient-administered.; Patient provided with external vibrator for self-use, as well as vaginal dilators.; Other: Standard care; Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.
Active Comparator: Dilator/standard therapy; Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).	Other: Standard care; Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	Qualitative questionnaire	12-18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	Qualitative questionnaire	12-24 months
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?	Questionnaire - FSDS (above)	12-24 months
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?	Questionnaire - FSFI (above)	12-24 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Principal Investigator: Jess Gaddie, Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginismus
• Other Study ID Numbers: 278027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No