Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Vibrator - patient-administered. | Other | Patient provided with external vibrator for self-use, as well as vaginal dilators. |
|
| 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? | 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. |
| 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? | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jess Gaddie | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambrose King Sexual Health Centre | London | E1 2BB | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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? | 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. | 5 patients in intervention group and 6 in control group were lost to follow up. | Posted | Mean | Standard Deviation | mean score | 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. |
|
6-24 months (intervention mean 10 months, control group mean 11.5 months) From initial contact to final interview.
Patents were encouraged to report adverse events via email or contact with research team through study completion, as per study duration above, no events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Gaddie | Barts Health NHS Trust | 020 7480 4737 | j.gaddie1@nhs.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2022 | May 27, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D052065 | Vaginismus |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Other | Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources. |
|
| 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? | 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. | 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? | 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. | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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? | 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. | 15 in each group; 11 were Lost to Follow up in total | Posted | Count of Participants | Participants | 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 | 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? | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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? | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |