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

NCT04635345 | Completed Results

• 1 other identifier: 278027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginismus

Outcome Measures

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?

  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.

  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.

Secondary Outcomes (3)

• 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?

  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.

• 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?

  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.

• 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?

  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.

Study Arms (2)

Vibrator Therapy + dilator/standard therapy

EXPERIMENTAL

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.; Other: Standard care

Dilator/standard therapy

ACTIVE COMPARATOR

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

Interventions

External Vibrator - patient-administered. OTHER

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

Vibrator Therapy + dilator/standard therapy

Standard care OTHER

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

Dilator/standard therapy; Vibrator Therapy + dilator/standard therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Ambrose King Sexual Health Centre

London, E1 2BB, United Kingdom

Location

MeSH Terms

Conditions

Vaginismus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jessica Gaddie
• Organization: Barts Health NHS Trust

j.gaddie1@nhs.net

020 7480 4737

Study Officials

• Jess Gaddie

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: November 19, 2020
• Study Start: August 11, 2021
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)