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

NCT ID: NCT04635345

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2024-06-12

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.

Conditions

Vaginismus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

External Vibrator - patient-administered.

Intervention Type: OTHER

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

Standard care

Intervention Type: OTHER

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

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).

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

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

Interventions

External Vibrator - patient-administered.

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

Intervention Type: OTHER

Standard care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jess Gaddie

Role: PRINCIPAL_INVESTIGATOR

Barts & The London NHS Trust

Locations

Ambrose King Sexual Health Centre

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

278027

Identifier Type: -

Identifier Source: org_study_id