N/A
N=30
Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus)
Vaginismus
Bottom Line
View on ClinicalTrials.gov: NCT04635345 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: 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? — 4.3 mean score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- External Vibrator - patient-administered. (Other); Standard care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Barts & The London NHS Trust
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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? |
4.3 | — |
| SECONDARY 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? |
6; 7 | — |
| SECONDARY 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? |
31.80; 29.67; 25.90; 17.89 | — |
| SECONDARY 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? |
17.15; 21.53; 20.01; 22.62 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04635345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.