Trial Outcomes & Findings for Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus) (NCT NCT04635345)

Last Updated: 2025-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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.

Results posted on

2025-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	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. External Vibrator - patient-administered.: Patient provided with external vibrator for self-use, as well as vaginal dilators. Standard care: 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). Standard care: Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.
Overall Study STARTED	15	15
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vibrator Therapy + Dilator/Standard Therapy n=15 Participants 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. External Vibrator - patient-administered.: Patient provided with external vibrator for self-use, as well as vaginal dilators. Standard care: Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.	Dilator/Standard Therapy n=15 Participants Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel). Standard care: Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.7 years n=5 Participants	28.7 years n=7 Participants	26.7 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: 5 patients in intervention group and 6 in control group were lost to follow up.

Outcome measures

Outcome measures
Measure	Vibrator Therapy + Dilator/Standard Therapy n=10 Participants 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.	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).
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 Standard Deviation 0.67	—

SECONDARY outcome

Population: 15 in each group; 11 were Lost to Follow up in total

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.

Outcome measures

Outcome measures
Measure	Vibrator Therapy + Dilator/Standard Therapy n=10 Participants 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.	Dilator/Standard Therapy n=9 Participants Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).
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 Participants	7 Participants

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Vibrator Therapy + Dilator/Standard Therapy n=10 Participants 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.	Dilator/Standard Therapy n=9 Participants Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).
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? pre intervention FSDS	31.80 score on a scale Standard Deviation 10.97	29.67 score on a scale Standard Deviation 5.56
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? post intervention FSDS	25.90 score on a scale Standard Deviation 8.72	17.89 score on a scale Standard Deviation 7.78

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Vibrator Therapy + Dilator/Standard Therapy n=10 Participants 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.	Dilator/Standard Therapy n=9 Participants Patient will receive standard therapy (initial appointment, referral for womens health physiotherapy or psychosexual counselling as standard, together with vadinal dilators and lidocaine gel).
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? Pre-intervention score FSFI	17.15 score on a scale Standard Deviation 7.5	21.53 score on a scale Standard Deviation 2.74
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? post intervention score FSFI	20.01 score on a scale Standard Deviation 8.09	22.62 score on a scale Standard Deviation 7.52

Adverse Events

Vibrator Therapy + Dilator/Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dilator/Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Gaddie

Barts Health NHS Trust

Phone: 020 7480 4737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place