A Pilot Study Assessing the Feasibility of Using Clitoral Vibrators to Aid Vaginal Dilator Therapy in Women Presenting to Psychosexual Services With Vaginismus.
Phase: NA
Conditions: Vaginismus
Sponsor: Barts & The London NHS Trust

 
 
 
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JRMO Research Protocol for  
Interventional Studies  
 
 
Full Title  
A controlled pilot study assessing the 
feasibility of using clitoral vibrators to aid 
vaginal dilator therapy in women presenting 
to psychosexual services with vaginismus. 
 
Short Title 
Feasibility of use of vibrators with vaginal 
dilators for vaginismus 
 
Sponsor 
 
Barts Health NHS Trust 
 
Contact person: 
 
Dr Mays Jawad 
Research & Development Governance 
Operations Manager 
Research Services 
Dept W 
69-89 Mile End Road 
London, E1 4UJ 
 
Phone: 020 7882 7275/6574 
 
Email: research.governance@qmul.ac.uk 
 
 
IRAS Number 
278027 
 
Edge Number 
136594 
REC Reference 
 
 
Chief Investigator 
Dr Jessica Gaddie 
Specialist Registrar HIV/GUM 
Barts Health NHS Trust, AKC, The Royal 
London Hospital, Whitechapel Rd, London, E1 
1BB 
07779286544 
j.gaddie1@nhs.net 
 
List of sites 
AKC, Royal London Hospital 
AS ABOVE 
 
List of laboratories 
N/A 
 
List of technical departments 
N/a 
 
List of central facilities 
N/A 

 
 
 
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1. Contents 
 
1. 
Contents ......................................................................................................... 2 
2. 
Glossary ......................................................................................................... 5 
3. 
Signature page ............................................................................................... 6 
4. 
Summary and synopsis .................................................................................. 6 
5. 
Introduction ..................................................................................................... 8 
5.1 
Preclinical data .......................................................................................... 10 
5.2 
Clinical data .............................................................................................. 11 
5.3 
Rationale ................................................................................................... 11 
5.4 
Risks / benefits .......................................................................................... 11 
6. 
Study objectives ........................................................................................... 12 
6.1 
Primary objective....................................................................................... 12 
6.2 
Secondary objective .................................................................................. 12 
6.3 
Primary endpoint ....................................................................................... 12 
6.4 
Secondary endpoint .................................................................................. 12 
7. 
Study population ........................................................................................... 12 
7.1 
Inclusion criteria ........................................................................................ 13 
7.2 
Exclusion criteria ....................................................................................... 13 
8. 
Study design ................................................................................................. 13 
9. 
Study procedures ......................................................................................... 15 
10. 
Assessment and management of risk ........................................................... 16 
11. 
Statistical considerations .............................................................................. 16 
11.1 Sample size .............................................................................................. 16 
11.2 Method of analysis .................................................................................... 16 
12. 
Ethics ........................................................................................................... 17 
12.1 Annual Safety Reporting ........................................................................... 17 

 
 
 
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13. 
Public Involvement........................................................................................ 18 
14. 
Data handling and record keeping ................................................................ 18 
14.1 Data management ..................................................................................... 18 
14.2 Source data ............................................................................................... 18 
14.3 Confidentiality ........................................................................................... 18 
14.4 Record Retention and Archiving ................................................................ 18 
15. 
Laboratories ................................................................................................. 19 
16. 
Interventions and tools .................................................................................. 19 
16.1 Devices ..................................................................................................... 19 
16.2 Techniques and interventions ................................................................... 19 
16.3 Tools ......................................................................................................... 19 
16.4 Medicinal product ...................................................................................... 20 
16.5 Other biological or chemical products ........................................................ 20 
17. 
Safety reporting ............................................................................................ 20 
17.1 Adverse Events (AEs) ............................................................................... 20 
17.2 Adverse Reaction (ARs) ............................................................................ 20 
17.3 Notification and reporting of Adverse Events and Reactions ..................... 21 
17.4 Serious Adverse Events (SAEs) or reactions ............................................ 21 
17.5 Notification and reporting of Serious Adverse Events ................................ 21 
17.6 Urgent Safety Measures ............................................................................ 21 
17.7 Annual Safety Reporting ........................................................................... 22 
17.8 Overview of the Safety Reporting responsibilities ...................................... 22 
18. 
Monitoring and auditing ................................................................................ 22 
19. 
Trial committees ........................................................................................... 22 
20. 
Finance and funding ..................................................................................... 22 
21. 
Indemnity ...................................................................................................... 23 
NHS indemnity scheme will apply. It provides cover for the design, management, and 
conduct of the study. ............................................................................................... 23 

 
 
 
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22. 
Dissemination of research findings ............................................................... 23 
23. 
References ................................................................................................... 23 
 
 

 
 
 
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2. Glossary 
 
Dyspareunia – pain with penetrative sex. 
FSD - Female Sexual Dysfunction 
FSFI - Female Sexual Function Index  
FSDS -  Female Sexual Distress Scale 
GPPD - genito-pelvic pain/penetration disorder. This diagnostic term recognises the 
frequent overlap between the conditions of vaginismus and vulvodynia 
Vaginismus results from the involuntary spasm of the pelvic floor muscles which 
surround the vaginal wall. 
Vulvodynia chronic vulvar pain of at least three months duration 
Vestibulodynia – Often used to describe vulvar pain at the introitus, or entrance to 
the vagina 
 
 

 
 
 
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3. Signature page 
 
 
 
 
Chief Investigator Agreement 
 
The study as detailed within this research protocol will be conducted in accordance 
with the principles of Good Clinical Practice, the UK Policy Framework for Health and 
Social Care Research, and the Declaration of Helsinki and any other applicable 
regulations. I agree to take responsibility for the statistical analysis and oversight of 
this study. 
 
 
Chief Investigator Name: 
Jessica Gaddie 
 
Signature: 
_________________ 
 
Date: 
_________________  20/09/2022 
 
 
4. Summary and synopsis 
 
Short title 
Feasibility of use of vibrators with vaginal dilators for 
vaginismus 
Methodology 
Feasibility study 
Research sites 
AKC, Barts Health NHS Trust, E11BB 
Objectives / aims 
Firstly, is vibration therapy (through the use of handheld 
vibrators on clitoral and vulval area) acceptable to women 
as part of medical management of vaginismus, alongside 
current medical management. 
 
Does the use of external genital (clitoral/ vulval) vibrators 
help women to progress more easily with the use of vaginal 
dilators compared to women not using these? Is there any 
self-reported difference in experiences of pleasure or 
enjoyment around sexual experiences in the two groups of 
women? Are there any differences noted in reported ability 
to have penetrative sexual intercourse? 
Number of 
participants 
30 
Inclusion and 
exclusion criteria 
Inclusion: 
Female 
>18 years old 
Clinical diagnosis of Vaginismus (self-reported difficulties 
with penetration and genital exam consistent with a degree 
of vaginismus) 
Willing to be enrolled in pilot study: 
 
 

 
 
 
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Exclusion: 
Any vulval skin dermatoses excluding medical management 
of vaginismus 
Transgender male / on testosterone therapy 
Symptoms of genital herpes episode in preceding 3 months 
Unable to speak/ understand English or needing an 
interpreter 
Declines to be enrolled in research study 
Pregnancy 
 
 
Statistical 
methodology and 
analysis (if 
applicable) 
n/a 
Study duration 
Up to 48 months 
 

 
 
 
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5. Introduction 
 
VITA DIVA- Vibration Therapy And Dilators for Vaginismus 
 
Vaginismus results from the involuntary spasm of the pelvic floor muscles which 
surround the vaginal wall. This can make sexual intercourse uncomfortable, painful, 
or impossible, with resultant impacts on a woman’s sexual pleasure and ability to 
conceive. There is often overlap with vulvodynia (also termed vestibulodynia), 
chronic vulvar pain of at least three months duration.  Various clinical definitions have 
been proposed for vulvodynia or vestibulitis.  
 
Successful treatment for both vulvodynia and vaginismus relies often on both medical 
and psychosocial interventions alongside self-help and practice. Current medical 
therapy for vaginismus often consists of the use of topical local anaesthetic gel, 
sometimes in addition to oral medications such as low dose Tricyclic Antidepressants 
together with recommendation of progressive vaginal dilator therapy (often termed 
systemic desensitisation) and physiotherapy. The fact there is not a clearly culpable 
etiology (and indeed causes are likely to be multifactorial) means that there is no 
‘gold standard’ treatment for vaginismus and vulvodynia (Zolnoun, 2008). A multi-
modal approach is recommended. 
 
Anecdotally, some women find that clitoral stimulation can sometimes have a positive 
impact on the ability to progress with vaginal dilator treatment and general enjoyment 
of sexual intimacy, but this has not yet been evaluated in a research setting.  
 
Background  
 
 
Various clinical definitions exist for vaginismus and vulvodynia, which have been 
recognised as a syndrome by the American Medical Association in the DSM-5 as 
genito-pelvic pain/penetration disorder (GPPD). This diagnostic term recognises the 
frequent overlap between the conditions of vaginismus and vulvodynia (AMA, 2013). 
Diagnosis per the DSM-5 criteria requires the presence of one of the following: 
persistent or recurrent difficulties with vaginal penetration during intercourse; marked 
vulvovaginal or pelvic pain during penetrative intercourse or attempts; fear or anxiety 
about vulvovaginal or pelvic pain in anticipation of, during, or as a result of vaginal 
penetration; or marked tensing or tightening of the pelvic floor muscles during 
attempted vaginal penetration. Additional criteria are presence of symptoms for at 
least six months, significant distress, and not explained by a diagnosis of non-sexual 
disturbance, causing relationship problems and not attributed to the effects of any 
substance or any other medical condition. 
 
In review of literature, searched for the terms vulvodynia, vestibulodynia, female 
genital pain, sexual disorders, and vibration, vibrator or clitoral or genital stimulation. 
Of the 85 results, 9 were relevant and in English. Of these, one related to the use of 
vaginal dilators, 5 related to genital vibratory stimulation devices, 3 related to genital 
stimulation and perception of pain.  No studies assessing the acceptability of clitoral 
vibrators specifically in self-treatment of patients with vaginismus were found.  
 
Genital stimulation/ sensation and pain perceptions 
 

 
 
 
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Calens et al carried out a web-based questionnaire of sexually active women n=256, 
median age 22 range 18-49. Questions included the Female Sexual Function Index 
(FSFI) and the Female Sexual Distress Scale (FSDS). Women reported the clitoris to 
be more sensitive than the vagina in terms of pleasurable responses, but not painful 
response. Women with Female Sexual Dysfunction reported impaired self-perceived 
genital sensation, less sexual pleasure and orgasm, and more association of orgasm 
with discomfort in the genital area than women without FSD. They conclude that 
“enhancing the pleasurableness of genital sensations, especially during partnered 
sex, could decrease the likelihood of experiencing pain and concomitant FSD” 
(Calens, 2016). 
 
Paterson et al found that women who masturbated to orgasm in private found that 
this appeared to maintain pleasurable genital sensitivity, but increase in pain 
sensitivity with higher vulvar pain sensitivity when orgasm occurs. Enhancing 
stimulation pleasurableness, psychological sexual arousal can mitigate normative 
increases in pain sensitivity during sex(Paterson, 2013). 
 
Whipple et al investigated the effectiveness of genital self-stimulation in elevating 
pain thresholds. This was a study of only 10 women who applied pleasurable 
sensations to the anterior vaginal wall, the posterior vaginal wall, and the clitoris. 
Increases in pain thresholds but not tactile thresholds were noted in this group 
compared to distraction control (Whipple, 1988). 
 
 
Use of devices in self-directed therapy for vaginismus and vulvodynia: 
 
One study assessed the acceptability of vulvar vibration therapy as a treatment for 
vulvodynia. 69 patients enrolled of whom 49 were eligible for analysis. Vulvular pain 
and dyspareunia were the primary complaints, and median duration of these was two 
years and three years respectively (Zolnoun, 2008). Although this may be a 
somewhat different population; (the primary presenting complaint was vulvodynia or 
dyspareunia, as opposed to vaginismus, and only two of the 49 had ever used 
vaginal dilators). Furthermore, it was acknowledged in the study that the 
generalisability of results was limited as the study population was primarily white, 
married, well-educated and from a single geographical location. 83% of those 
surveyed who had used vulvar vibration therapy for at least two weeks had found it 
an acceptable and 73% found it a convenient treatment. In this study, Zolnoun et al. 
proposed that VVT therapeutic rationale was based on the anti-nociceptive properties 
of vibration and on the favourable response of vulvodynia to physical therapy.  
 
Genital vibration devices were found to result in improvements in sexual function, 
satisfaction, sexually related distress and genital sensation in women with arousal 
and orgasm disorders in one study enrolling 70 women, 37 of whom were followed 
up after a period of 3 months (Guess, 2017). This was a single-arm study enrolling 
women with arousal and/or orgasm disorders, so again a slightly different study 
population to the proposed study. Mean age was 35.5, and 66% had never or seldom 
used genital vibratory device. The Female Sexual Function Index (FSFI) and the 
Female Sexual Distress Scale (FSDS) were carried out at baseline and follow up 
which was at 3 months. 
 
Herbenick et al acknowledged that vibrators are frequently recommended by 
clinicians for female sexual dysfunction, although there is little awareness of the 
correlation of this to sexual function. 2, 056 women participated in the internet based 

 
 
 
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survey (54% of the 3, 800 nationally representative sample who were invited). This 
assessed the prevalence of vibrator use, and the relationship between vibrator use 
and psychological well-being. Tbe Female Sexual Function Index was used. 
Prevalence of vibrator use was 52.5%, and use was significantly correlated 
(P<0.001) with having performed genital self-examination in the past month. Vibrator 
use was associated with more positive sexual function (including higher levels of 
desire and arousal and lower levels of pain). It was rarely associated with side 
effects(Herbenick, 2009). 
 
Rubin et al and Billips et al published clinical guides for role of mechanical devices in 
treating female sexual dysfunction. These acknowledge the paucity of clinical 
evidence of effectiveness but also highlight the fact that these are generally safe and 
without significant adverse effect. (Rubin 2019; Billips 2002) 
 
Proposed study 
 
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. We 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. We propose based on the evidence above that vibrator therapy may 
help women with female sexual dysfunction to use vaginal dilators, based on study 
showing improvements with sexual distress and satisfaction. 
 
 
Enrollment 
 
This is a nonrandomized controlled trial, with the initial cluster of patients receiving 
standard therapy, and the second cluster receiving standard therapy plus vibrator. 
We aim to recruit an initial 15 participants who will receive standard therapy, and 
another 15 who will receive an external vibrator.  
 
We expect this to take place over approximately 24-48 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. Inclusion and exclusion criteria have already 
been outlined. 
 
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 6-24months afterward the initial consultation at the 
patients consent.   
 
 
 
5.1 
Preclinical data  
 

 
 
 
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Preclinical trials are not applicable in this study. 
 
Vibrators we propose to use in this study are not medical devices and are made from 
FDA-approved medical grade silicone.  
 
5.2 
Clinical data  
 
 
A full description of available and relevant clinical data is documented in the 
review of literature in section 5.0. 
 
Clinical data which will be gathered at baseline in order to compare two groups: 
Age, Parity, previous vaginal delivery, postmenopausal/premenopausal, 
gynaecological surgery, sexual orientation, patient self-described ethnicity, 
gender 
 
5.3 
Rationale 
 
 
Vaginismus is the involuntary spasm of the pelvic floor muscles which surround 
the vaginal wall. It affects roughly 13 to 34% of premenopausal women and 
6 to 45% of postmenopausal women (Meana, 2017). Vulvodynia, which has 
significant overlap with vaginismus, was estimated to affect 16% of women 
based on a National Institutes of Health (NIH) population-based study 
(Harlow & Stewart, 2003). Vaginismus can make sexual intercourse 
uncomfortable, painful, or impossible, and can have resultant impacts on a 
woman’s sexual pleasure and ability to conceive and is associated with 
depression and anxiety. It can lead to secondary vulvodynia, or vulvodynia 
can co-exist.  
 
Successful treatment relies often on both medical and psychosocial interventions 
alongside self-help and practice, although no standardised treatment exists. 
Current medical therapy for vaginismus often consists of the use of topical 
local anaesthetic gel, often in addition to oral medications such as low dose 
Tricyclic Antidepressants together with recommendation of progressive 
vaginal dilator therapy and physiotherapy. Whilst no one treatment or 
approach has a high degree of success, a combined approach has been 
shown to offer the most significant improvements. 
 
Whilst anecdotally, some women find that clitoral stimulation can sometimes have a 
positive impact on the ability to progress with vaginal dilator treatment and 
enjoyment of sexual intimacy, this has not yet been evaluated in a research 
setting. This study looks at the feasibility and acceptability of using clitoral 
vibration therapy, alongside current therapy, for women with Vaginismus.  This 
has the potential to guide clinicans’ recommendations, which are currently not 
based in evidence, and if found to be acceptable, to pave the way for studies into 
efficiacy. 
 
5.4 
Risks / benefits  
 
 

 
 
 
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Of 49 eligible patients with vulvodynia, 83% of those surveyed who had used vulvar 
vibration therapy for at least two weeks had found it an acceptable treatment 
(Zolnoun, 2008) 
Rubin et al published a clinical reference guide on sexual devices for clinicians in 
2019 which stated that risks associated with sexual devices (such as vibrators) 
were traumatic injury or infection. Since we are recommending use of the 
vibrator for external use only, barrier use over sexual devices if shared, and 
proper disinfection to reduce risk of infection (Rubin, 2019).  
The treatment period duration is 6-12 months.other studies looking at vulvar vibration 
therapy as an intervention have study periods of approximately 3-6 months.. We find 
that this allows patients to have completed  any recommended intervention.  
6. Study objectives 
 
 
6.1 
Primary objective 
 
Is vibration therapy (through the use of handheld vibrators on clitoral and vulval area) 
acceptable to women as part of medical management of vaginismus and 
vaginismus/vulvodynia, alongside current medical management. 
 
 
6.2 
Secondary objective 
 
 
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? 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 and FISI Scores? Do 
more women report enjoyable sex? Are there any differences noted in reported ability 
to have or enjoyment of penetrative sexual intercourse? 
 
 
6.3 
Primary endpoint 
 
Baseline and follow up questionnaires will be used – to assess acceptability and 
perceived acceptability of control therapy and intervention. 
 
 
6.4 
Secondary endpoint 
 
Baseline and follow up questionnaires will be used specific to study and also FSDS 
and FISI. 
 
7. Study population 
 
Potential participants will be identified from the patients presenting to the Female 
Sexual Wellbeing Clinic. Identification of participants beyond this will not be needed. 
The identification of suitable participants will be done by the clinicians, using the 
inclusion and exclusion criteria taken into account. The clinic is a joint clinic run by a 
clinical psychologist and medical doctor, who will be providing the initial 

 
 
 
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questionnaire and the follow up phone interview. Medical students (with honary 
contract obtained) may also carry out interviews but not consent for the study. 
 
Potential participants will be advised of the study verbally and given a written leaflet 
during their clinic appointment. Enrolment will be offered on the day on the 
understanding that the patient can decide to leave the study at any point. 
 
Informed consent will be obtained. Consent will be taken by either the medical doctor 
or clinical psychologist in clinic. Verbal explanation of the study, together with a 
leaflet explaining the study will be provided. 
 
If the study participants wish to enrol on the day, they will be able to. This may be 
preferable for convenience to avoid having to return to the clinic. Otherwise they will 
have 24hrs - 1 week to enrol. Enrolling on the day may be a preferred option for the 
patient so they do not have to return to clinic again. If they wish, they can take the 
written information away with them and return on another day. 
 
Participants will enrol for approximately 6-24 months; this will be from the initial 
consultation until the follow up questionnaire, although no contact in the interim will 
be required as part of the research project there may be contact as part of any 
medical or psychological intervention separate to the project. 
 
7.1 
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. 
 
 
7.2 
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. 
 
Pregnancy – via history from patient. 
 
 
 
8. Study design 
 

 
 
 
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This study is a feasibility and acceptability study. The collection of qualitative data 
collection will be questionnaires, and interviews as described below. The data 
obtained will be analysed using thematic analysis to identify topics and patterns.  
In addition two formal, validated questionnaires will be used that can be scored to 
assess any change in sexual function and/or sexual distress. 
 
Group 1 (Standard treatment) 
We aim to recruit an initial 10-15 participants who will receive standard therapy with 
vaginal dilators and current medical management which usually consists of some or 
all of lidocaine gel (topical local anaesthetic applied to the vulva), tricyclic 
antidepressants (used in co-existing vulvodynia or vulval pain syndromes) and 
physiotherapy. Standard treatment also includes Group or individual psychotherapy.   
 
Group 2 (Intervention) 
In addition the standard treatment outlined above, the next 10-15 recruited will 
receive dilators and an external vibrator. This will take place over 6-24 months in a 
joint psychosexual clinic which is led by a medical doctor and a clinical psychologist.  
 
Both groups: 
Trial information will be given at the initial appointment. If the patient wishes to enrol, 
than an initial baseline questionnaire will be given for a patient to fill out after the 
clinic. A private space will be provided for the patient to do this, and there will be an 
offer for the patient to return to do this if preferred. Two formal, validated 
questionnaires will be carried out at baseline and follow up. These are the Female 
Sexual Distress Scale - R (FSDS) and the Female Sexual Function Index.  

 
 
 
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The follow up questionnaires will be filled out by phone contact 6-24 months after the 
initial consultation at the patients consent if they agree to remain enrolled in the trial 
for both group 1 and group 2. This will take approximately 30 mins and will be 
arranged at a time convenient for the patient. This interview will be carried out by a 
doctor. Answers will be recorded directly onto the follow up questionnaire proforma.   
 
4 point Likert scale 1 (Strongly disagree) to 4 (Strongly agree) 
9. Study procedures 
 
• 
Informed consent – verbal and written will be given, patients will be offered 
opportunity to enrol on the day (for convenience) or to return at another point 
to enrol. 
• 
Screening and recruitment – as outlined previously recruitment will be directly 
from clinic 
• 
Randomization – this is a non-randomized controlled trial, as trial participants 
need to be identified as time goes on, and a certain number of control and 
intervention participants are needed. The initial 10-15 recruited will receive 
standard treatment, and then the next 15 will receive intervention.  
 
Study interventions 
 
Study intervention  
Contact 
(Visit) 1 
Contact 2 
 
 
Medical history 
X 
 
 
 
Consent 
X 
 
 
 
Baseline Questionnaires 
(FSDS, FSFI, custom 
questionnaire) 
X 
 
 
 
Phone Interview (FSDS, 
FSFI, custom 
questionnaire) 
 
X 
 
 
 
Vaginal dilators will be provided to both groups (if available) and external genital 
vibrators to the second (intervention) group. 
 
• 
Concomitant medications – per standard treatment, patients with vulvodynia 
may be prescribed topical lidocaine gel and may also receive nortriptyline if 
there is unprovoked vulvodynia present.  
 
• 
Criteria for discontinuation – if patients withdraw consent for being enrolled in 
the study then follow up will discontinue.  
 
• 
Procedure for collecting data, including Case Report Forms (CRFs) and 
storage: CRFs will be filled out electronically, and stored in a password 
protected file. The research data will be archived for 25 years according to 
Queen Mary University of London/ Barts Health NHS Trust policy, JRMP SOP 
20.  
 
 

 
 
 
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• 
Follow up will be via phone interview. Patients enrolled will receive a contact 
email address in case of queries in the meantime during research period. 
 
• 
End of study duration will be at follow up questionnaire (at 6-24 months post 
initial appointment and questionnaire)  
 
10. Assessment and management of risk 
 
Patients the Female Sexual Wellbeing clinic sometimes find discussions 
embarrassing as we discuss sexual difficulties. This is not confined to patients in the 
study. We aim to minimise embarrassment and difficulties discussing sensitive topics 
by providing a questionnaire at baseline, and a follow up phone call rather than face 
to face interview is also likely to help reduce embarrassment. If the pilot study 
suggests that patients would prefer a different form of communication then this will 
feed into any further research. Financial loss for participants is not expected. 
 
The clitoral vibrators supplied to the patients in the intervention group are already 
available for sale to people in the UK. No published long term side effects from the 
use of these are known or foreseen.  
 
Rubin et al published a clinical reference guide on sexual devices for clinicians in 
2019 which stated that risks associated with sexual devices (such as vibrators) 
were traumatic injury or infection. Since we are recommending use of the 
vibrator for external use only, barrier use over sexual devices if shared, and 
proper disinfection to reduce risk of infection (Rubin, 2019).  
 
In the unexpected case of an SAE this will be reported via the appropriate routes and 
the study management group will decide on whether the study should proceed or not. 
Participants will have an email address to contact the CI in case of AE or SAE. 
 
No risks to researchers foreseen. 
 
 
11. Statistical considerations 
Qualitative study N/a 
11.1 
Sample size 
 
Pilot / Feasibility study 
30 
This is a realistic number we can expect to recruit (15-20 in each study arm) over the 
course of 24-48months as a feasibility study. 
11.2 
Method of analysis  
 
 
Qualitative analysis with thematic analysis. Some numerical analysis of formalised 
questionnaires, although statistical analysis will not be relevant will small numbers 
proposed. 
 

 
 
 
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12. Ethics 
 
 
 
We do not anticipate any complex ethical, legal or management issues arising 
from the study at present. We are not proposing a deviation away from our current 
standard of care, but an additional therapy to be offered to patients enrolled in the 
intervention arm of the study. 
Informed consent: patients will be given the opportunity to enrol in the study at the 
initial appointment but will be given the option to return 24hrs to one week later if they 
wish to enrol later.  
 
Recruitment: 
- 
We have necessary and exclusion criteria, one of which being requirement of 
use of a translator. The initial appointment and consenting for the study will 
involve a lot of information verbally, and translating questionnaires and patient 
information leaflets will not be an option for us. 
 
 
Burdens foreseen: 
- 
It is likely that explanation of the research, and how to use a clitoral vibrator, 
will require some additional time investment during the clinic although again 
we do not predict that this will have a negative impact on the quality of service 
offered in the clinic. 
- 
The burden to the patient we feel will be minimal, with the offer of enrolment 
into the study on the day of clinic this will potentially avoid unnecessary visits. 
The follow up questionnaire will be via phone interview so further vists will be 
avoided. 
Benefits foreseen: 
- 
Patients will not receive monetary compensation but if in intervention group 
will receive a clitoral vibrator as part of the study which they will be able to 
keep 
 
Other impacts: 
 
 Patients in our clinic sometimes find discussions embarrassing as we discuss 
sexual difficulties. This is not confined to patients in the study. We aim to minimise 
embarrassment and difficulties discussing sensitive topics by providing a 
questionnaire at baseline, and a follow up phone call rather than face to face 
interview is also likely to help reduce embarrassment. If the pilot study suggests that 
patients would prefer a different form of communication then this will feed into any 
further research. 
 
Conflict of interest: 
- 
None foreseen. None of the investigators are receiving any personal 
monetary grant or fund from study funders. 
 
 
 
 
 
 
12.1 
Annual Safety Reporting  
 

 
 
 
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The CI will send an Annual Progress Report to the REC and the sponsor using the 
HRA template on the anniversary of the REC “favourable opinion”. 
 
13. Public Involvement 
 
This is a pilot study and is aiming only to look at feasibility and acceptability. Results 
and feedback from this study can therefore be used to guide any further research. 
Findings will be disseminated via the wordpress site we currently use to provide 
information to patients and staff, and we will seek advice from patients in how they 
wish us to disseminate findings and who they feel we should reach out to with 
results. 
14. Data handling and record keeping 
 
14.1 
Data management 
Methods of data capture:  
- 
Patient medical records 
- 
Baseline and follow up questionnaire 
- 
Design of data capture forms – transcription of questionnaire results onto spreadsheet 
for further analysis 
- 
Transfer and storage of data in central study database on shared drive password 
protected. 
 
14.2 
Source data 
Source Data (baseline questionnaire, follow up questionnaire) generated by study. 
Source documents – medical history, patient demographics (age) will be accessed 
only to obtain the medical history necessary for the study (diagnosis, treatments 
provided, patient age). 
 
 
14.3 
Confidentiality 
 
Potential participants will be identified from the patients presenting to the Female 
Sexual Wellbeing Clinic. Identification of participants beyond this will not be needed. 
Information related to study participants will be kept confidential and managed  
in accordance with the Data Protection Act, the General Data Protection Regulation 
(GDPR) 2018, NHS Caldecott Principles, the UK Policy Framework for Health and 
Social Care Research, and the conditions of Research Ethics Committee favourable 
opinion. 
Access to participant healthcare records and source documents will only be by 
treating medical team which includes CI and PI. 
Anonymisation of research data will take place upon data collection. 
 
 
14.4 
Record Retention and Archiving 
The research data will be archived for 25 years according to Barts Health NHS Trust policy. 
The data will be archived in the Modern Records Facility, 9 Prescot Street, Aldgate, 
London, E1 8PR, in physical form. After this point, the records will be destroyed. 
 

 
 
 
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15. Laboratories  
 
N/a 
 
 
16.  Interventions and tools  
 
16.1 
Devices 
 
Vibrator for external use. Not a medical device. Carries the CE MARK and complies 
with Directive 2011/65/EC Restriction on Hazardous Substances.  
 
 
 
16.2 
Techniques and interventions 
 
Patient information leaflet will be supplied, which will detail explanations of 
vaginismus and vulvodynia, female sexual arousal, and massage techniques useful 
in these conditions. 
The intervention group will receive an external clitoral vibrator for home use. 
 
 
 
16.3 
Tools 
 
 
Two formal, validated questionnaires will be used at baseline and at follow up in 
the study participants to assess response to treatment and intervention; the 
Female Sexual Distress Scale and the Female Sexual Function Index. 
 
The Female Sexual Distress Scale (FSDS) (Derogatis, 2002) measures sexually 
related personal distress in women. The reliability and validity of the scale 
was assessed in sexually functional and dysfunctional women in three 
studies of approximately 500 women. The revised version  contains 13 
questions. It has been used to assess treatment response. 
 
The FSDS-R measures patient-reported outcomes covering different aspects of 
sexual activity-related distress in women. Responses are scored from never 
(0) to always (4) and results in a total score of 0 to 52. Higher scores 
therefore equate to a higher reported level of sexual distress.  
The FSDS-R had considerable scale reliability – Cronback’s alpha values ranged 
from a=0.87 to a=0.93 and good test-retest reliability (intraclass correlation 
coefficient from r=0.74 to r=0.86. A cutoff score >11 was shown to be 
effective in differentiating women with and without Female Sexual 
Dysfunction. 
 

 
 
 
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The Female Sexual Function Index is another questionnaire which is widely used 
in the evaluation of female sexual dusfunction, assessing six main areas: 
desire, subjective arousal, lubrication, orgasm, satisfaction, and pain 
(Rosen, 2006). Higher scores equate to better sexual function. A score 
under 26.55 relates to low sexual function, with an individual score under 3.6 
signifies low function in that area (Wiegel, 2005).  
 
16.4 
Medicinal product  
 
N/a 
 
 
16.5 
Other biological or chemical products 
 
N/a 
 
17. Safety reporting  
 
 
Adverse Events (AEs) and Adverse Reactions (ARs) will be recorded. 
Serious Adverse Events (SAEs) and Serious Adverse Reactions (SARs) will be 
reported to the CI as medical assessor for the sponsor and coordinating team. 
All unexpected SARs (SUSARs) will be reported to the JRMO and REC. 
 
DEVICE DEFECTS, RECALLS and ALERTS 
 
The intervention is an external vibrator which is available for sale in the UK. It is not a 
medical device. 
 
17.1 
Adverse Events (AEs) 
 
An AE is any untoward medical occurrence in a participant to whom an intervention 
has been administered, including occurrences which are not necessarily caused by 
or related to that intervention. An AE can therefore be any unfavourable or 
unintended sign (including an abnormal laboratory finding), symptom or disease 
temporally associated with study activities. 
 
In a study of the effects of genital vibration therapy in women with arousal and 
orgasm disorders, light-headedness, agitation, headache, facial flushing, were each 
reported by 4-8% of participants, with 2% reporting some genital numbness, 
dizziness or cramping (Guess, 2008). 
 
17.2 Adverse Reaction (ARs)  
 
 
An AR is any untoward and unintended response in a participant to an intervention.  
All adverse events judged by either the reporting investigator or the sponsor as 
having a reasonable causal relationship to the intervention qualify as adverse 

 
 
 
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reactions. The expression ‘reasonable causal relationship’ means in general that 
there is evidence or an argument to suggest a causal relationship. 
 
 
17.3 
Notification and reporting of Adverse Events and Reactions 
 
 
If the AE is not defined as serious, the AE will be recorded in the study documents 
and the participant followed up by the research team. The AE will be documented in 
the participants’ source documents, the Case Report Form (CRF), and, where 
appropriate, medical records. 
 
 
17.4 
Serious Adverse Events (SAEs) or reactions 
 
 
A serious adverse event (SAE) is defined as an untoward occurrence that: 
• 
Results in death, 
• 
Is life-threatening, 
• 
Requires hospitalisation or prolongation of existing hospitalisation, 
• 
Results in persistent or significant disability or incapacity, 
• 
Consists of a congenital anomaly or birth defect, or 
• 
Is otherwise considered medically significant by the investigator. 
 
SARs will be reported to the REC where in the opinion of the Chief Investigator the 
event was serious and: 
• 
Related (it may have resulted from administration of any of the research 
interventions), and 
• 
Unexpected (the type of event is not listed in the protocol or other Reference 
Safety Information as an expected occurrence). 
 
 
17.5 
Notification and reporting of Serious Adverse Events  
 
 
Serious Adverse Events (SAEs) that are considered to be ‘related’ and ‘unexpected’ 
will be reported to the sponsor within 24 hours of learning of the event, and to the 
REC within 15 days in line with the required timeframe.  
 
 
  
 
17.6 
Urgent Safety Measures 
 
 
The CI will take urgent safety measures if necessary to ensure the safety and 
protection of the clinical study participant from immediate hazards to their health and 
safety. The measures will be taken immediately. The approval of the REC prior to 
implementing urgent safety measures is not required. However the CI will inform the 
sponsor and Research Ethics Committee (via telephone) of this event immediately.  

 
 
 
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The CI will inform the REC in writing within 3 days, in the form of a substantial 
amendment. The sponsor (Joint Research Management Office (JRMO)) will be sent 
a copy of the correspondence with regards to this matter.  
 
 
17.7 
Annual Safety Reporting 
 
 
The CI will send the Annual Progress Report to the REC using the HRA template (the 
anniversary date is the date on the REC “favourable opinion” letter) and to the 
sponsor.  
 
 
17.8 
Overview of the Safety Reporting responsibilities 
 
 
The CI is the medical assessor on behalf on the sponsor and will review all events 
reported. The CI will ensure that safety monitoring and reporting is conducted in 
accordance with the sponsor’s requirements.  
The CI and PIs will ensure all SAE reporting is conducted in accordance with the 
sponsors timelines. Any SAE will be acted upon within a week of receipt of and 
where necessary, any relevant patients contacted and the intervention will be 
recalled. 
 
 
18. Monitoring and auditing 
 
 
The sponsor or delegate retains the right to audit any study, study site, or central 
facility. Any part of the study may be audited by the funders, where applicable. 
 
  
This is an initial, small feasibility study. Proposals will go through an internal peer 
review process with our research lead.  Due to the low risk of safety issues 
associated with this intervention, no monitoring will occur routinely for the pilot study. 
Contact details are available for the patients if any issues occur. 
 
19. Trial committees 
 
A study management group consisting of the CI, PIs, collaborators, and any grant 
holders, will ensure appropriate oversight of the study data and participant safety. A 
meeting will be held in the case of any AE or issues raised by participants or 
investigators in the study. This is a small, single-centre study. A trial steering 
committee will not be necessary. 
 
 
 
 
20. Finance and funding 
 

 
 
 
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Subsidised (cost-price vibrators) from ‘Mysteryvibe’. 
Organisation:  
Mysteryvibe 
Soumayadip Rakshit (CEO) 
Mysteryvibe, 10 York Road 
London 
SE1 7ND 
 
 
21. Indemnity 
 
NHS indemnity scheme will apply. It provides cover for the design, management, and 
conduct of the study. 
 
 
 
22. Dissemination of research findings 
 
Will aim for peer reviewed publication, but if this does not happen then minimum 
would be dissemination on website and to the regional sexual health network. 
If participants wish they will be emailed a summary of the results. 
 
• 
Aiming for publication in a peer reviewed journal  
• 
The sponsor will be acknowledged in any write up 
• 
If published, the results will be accessible on a publically accessible database 
• 
Presentation at academic conferences if accepted – will apply for this 
• 
Communicating results to former study participants and the public – via email 
if participants agree to this 
• 
Involving research participants in the dissemination process – we will take 
input from participants in how they want the research disseminated if not 
covered by the above 
• 
Internal dissemination at Barts Health NHS Trust and Queen Mary University 
of London 
• 
Use of the results to change practice or to develop new research or 
innovation – will provide support for recommendation of vibration therapy for 
vaginismus/vulvodynia. 
 
 
23. References 
 
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders 
(DSM-5). 5th ed. Washington, DC: APA; 2013 
 
Callens N, Bronselaer G, De Sutter P, De Cuypere G, T’Sjoen G, Hoebeke P, Cools M. Costs of 
pleasure and the benefits of pain: self-percieved genital sensation, anatomy and sexual 
dysfunction. Sex Health. 2016 Feb;13(1):63-72 10.1071/SH15160 
 
Derogatis L, Raymond R, Leiblum S, Burnett A, Heiman J. The Female Sexual Distress Scale 
(FSDS): Initial Validation of a Standardized Scale for Assessment of Sexually Related Personal 

 
 
 
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Distress in Women. 2002. Journal of sex & marital therapy. 28. 317-30. 
10.1080/00926230290001448. 
 
Guess MK, Connell KA, Chidnoff S, Adekoya O, Richmond C, Nixon KE, Freeman K, Melman A. 
The Effects of a Genital Vibratory Stimulation Device on Sexual Function an dGenital 
Sensation. Female Pelvic Med Reconstr Surg. 2017. Jul/Aug;23 (4):256-262 
 
Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: 
Have we underestimated the prevalence of vulvodynia? Journal of the American Medical 
Women’s Association. 2003; 58(2):82–88 
 
Herbenick D, Reece M, Sanders S, Dodge B, Ghassemi A, Fortenberry JD. Prevalence and 
characteristics of vibrator use by women in the United States: results from a nationally 
representative study. 
J Sex Med. 2009 Jul;6(7):1857-66. doi: 10.1111/j.1743-6109.2009.01318.x. Epub 2009 May 7. 
 
 
Meana M, Fertel E, Maykut C. Treating genital pain associated with sexual intercourse. In: 
Peterson ZD. , ed. The Wiley Handbook of Sex Therapy. Chichester: Wiley Blackwell; 2017: 
98-114 
 
Paterson LQ, Amsel R, Binik YM. Pleasure and pain: the effect of (almost) having an orgasm 
on genital and nongenital sensitivity. J Sex Med 2013 Jun;10(6):1531-44. 
Doi:10.1111/jsm.12144 
 
Rosen R., Brown C., Heiman J., Leiblum S., Meston C., Shabsigh R., Ferguson D., D'agostino R. 
The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the 
assessment of female sexual function. J Sex Marital Ther. 2000;26:191–208 
 
Rubin ES, Deshpande NA, Vasquez PJ, Kellogg Spadt S. A clinical reference Guide on Sexual 
Devices for Ostetrician-Gynaecologists. Obstet Gynaecol. 2019 Jun;133(6):1259-1268 
 
Whipple B, Komisaruk BR, Analgesia produced in women by genital self-stimulation. J Sex 
Res. 1988 Jan;24(1):130-40. Doi: 10.1080/00224498809551403 
 
Wiegel M., Meston C., Rosen R. The female sexual function index (FSFI): Crossvalidation and 
development of clinical cutoff scores. J Sex Marital Ther. 2005;32:1–20 
 
Zolnoun, D., Lamvu, G., & Steege, J. (2008). Patient perceptions of vulvar vibration therapy 
for refractory vulvar pain. Sexual and Relationship Therapy, 23(4), 345-353. 
  
 
 
This protocol is based on JRMO Protocol template for Interventional Studies; 
version 2.0 August 2019