Understanding Factors Which Affect Willingness to Self-manage a Pessary for Pelvic Organ Prolapse: A Mixed Methods Study Aiming to Improve Access to Pessary Self-management.
Conditions: Prolapse; Female, Prolapse, Vaginal
Sponsor: Manchester University NHS Foundation Trust

 
 
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FULL/LONG TITLE OF THE STUDY 
Understanding factors which affect willingness to self-manage a pessary for pelvic organ prolapse: A 
mixed methods study aiming to improve access to pessary self-management. 
 
SHORT STUDY TITLE / ACRONYM 
What affects willingness to self-manage a pessary? 
 
PROTOCOL VERSION NUMBER AND DATE Version 1.10 04/08/22 
 
IRAS Number: 304120 
 
Sponsor’s Number: B01328 
 
 
Sponsor: Manchester University NHS Foundation Trust 
 
Funder: Health Education England (HEE) / National Institute for Health Research (NIHR) NIHR300519  
 
This project will be conducted in accordance with the study protocol and the ethical principles 
outlined by Good Clinical Practice (GCP) and the Declaration of Helsinki in its most current version 
 
 

 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the trial in compliance with the approved protocol and will adhere to 
the principles outlined in the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 
2004/1031), amended regulations (SI 2006/1928) and any subsequent amendments of the clinical 
trial regulations, GCP guidelines, the Sponsor’s (and any other relevant) SOPs, and other regulatory 
requirements as amended. 
 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the clinical investigation without the prior 
written consent of the Sponsor 
 
I also confirm that I will make the findings of the trial publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the trial will be given; and that any discrepancies and serious breaches of GCP from the 
trial as planned in this protocol will be explained. 
 
For and on behalf of the Trial Sponsor: 
Signature:  
 
 
Date: 
....../....../...... 
Name (please print): 
 
 
 
Position: 
 
 
 
Chief Investigator: 
Signature:  
 
Date: 
....../....../...... 
Name: Lucy Dwyer 
 
 
 
 
 
 
 
 
 
 

 
 
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 KEY TRIAL CONTACTS 
Chief Investigator 
Lucy Dwyer (Specialist Nurse) 
The Warrell Unit, Saint Mary’s Hospital, Manchester 
University NHS Foundation Trust, Manchester Academic 
Health Science Centre, Hathersage Road, Manchester M13 
9WL Lucy.dwyer@mft.nhs.uk 
0161 276 6910 
Academic Supervisor 
Professor Dawn Dowding (Chair in Clinical Decision-Making) 
Division of Nursing, Midwifery and Social Work, School of 
Health Sciences, Faculty of Biology, Medicine and Health, 
University of Manchester, Oxford Road, Manchester, M13 
9PL 
Dawn.dowding@manchester.ac.uk 
Clinical Supervisor 
Dr Rohna Kearney (Consultant Urogynaecologist) 
The Warrell Unit, Saint Mary’s Hospital, Manchester 
University NHS Foundation Trust, Manchester Academic 
Health Science Centre, Hathersage Road, Manchester M13 
9WL  
Rohna.kearney@mft.nhs.uk 
Sponsor 
Dr Lynne Webster 
Manchester University NHS Foundation Trust 
Research Office 
1st Floor, Nowgen Building 
29 Grafton Street 
Manchester 
M13 9WU 
0161 276 3565 

 
 
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Funder(s) 
Lucy Dwyer, Clinical Doctoral Research Fellow, NIHR300519 
is funded by Health Education England (HEE) / National 
Institute for Health Research (NIHR) for this research project 
 
 
 

 
 
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i. LIST of CONTENTS 
Contents 
KEY TRIAL CONTACTS ....................................................................................................................... 3 
i. LIST of CONTENTS ......................................................................................................................... 5 
iii. TRIAL SUMMARY ......................................................................................................................... 8 
iv. FUNDING AND SUPPORT IN KIND ............................................................................................... 9 
v. ROLE OF TRIAL SPONSOR ............................................................................................................. 9 
vi. KEY WORDS: .............................................................................................................................. 10 
vii. TRIAL FLOW CHART .................................................................................................................. 11 
1. 
BACKGROUND .................................................................................................................... 12 
2. 
RATIONALE ......................................................................................................................... 13 
3. 
OBJECTIVES ........................................................................................................................ 14 
3.1 Research aims 
14 
3.2 Research objectives 
14 
3.3 Hypothesis 
14 
4. 
METHODOLOGY ................................................................................................................. 15 
4.1. Mixed methods methodology 
15 
4.1.1 Quantitative methodology 
16 
4.1.2 Qualitative methodology 
16 
4.2 Intervention development methodology 
18 
5. 
QUANTITATIVE PHASE STUDY DESIGN .............................................................................. 19 
5.1 Quantitative phase setting 
19 
5.2 Quantitative phase inclusion criteria 
19 
5.3 Quantitative phase exclusion criteria 
19 
5.4 Quantitative phase participant identification 
20 
5.5 Quantitative phase consent 
20 
5.6 Quantitative phase payment/reimbursement 
20 
5.7 Quantitative baseline data 
21 
5.8 Quantitative phase data collection 
21 
5.9 Quantitative phase sample size 
22 

 
 
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5.10 Quantitative phase data analysis 
22 
5.11 Quantitative phase outputs 
22 
6. 
QUALITATIVE PHASE STUDY DESIGN ................................................................................. 23 
6.1 Qualitative phase setting 
23 
6.2 Qualitative phase inclusion criteria 
23 
6.3 Qualitative phase exclusion criteria 
23 
6.4 Qualitative phase participant identification 
24 
6.5 Qualitative phase consent 
24 
6.6 Qualitative phase payment/reimbursement 
25 
6.7 Baseline data 
25 
6.8 Qualitative phase data collection 
26 
6.9 Qualitative phase sample size 
27 
6.10 Qualitative phase data analysis 
27 
6.11 Qualitative phase outputs 
28 
7. INTERVENTION DEVELOPMENT PHASE STUDY DESIGN ............................................................ 29 
7.1 Intervention development phase setting 
29 
7.2 Intervention development phase inclusion criteria 
29 
7.3 Intervention development phase exclusion criteria 
29 
7.4 Intervention development phase participant identification 
30 
7.5 Intervention development phase payment/reimbursement for pessary using women 
30 
7.6 Intervention development phase consent 
30 
7.7 Intervention development phase data collection 
31 
8. INTERVENTION PILOT PHASE STUDY DESIGN ............................................................................ 34 
8.1 Intervention pilot phase setting 
34 
8.2 Pilot phase inclusion criteria 
34 
8.3 Intervention pilot exclusion criteria 
34 
8.4 Intervention pilot phase data collection 
35 
9. END OF STUDY ........................................................................................................................... 36 
10. DATA MANAGEMENT............................................................................................................... 36 
10.1 Data collection tools and source document identification 
36 
10.2 Access to Data 
37 

 
 
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10.3 Archiving 
38 
11. MONITORING, AUDIT & INSPECTION ...................................................................................... 38 
12. ETHICAL AND REGULATORY CONSIDERATIONS ....................................................................... 38 
12.1 Study approval 
38 
12.2 Amendments to the Protocol 
39 
12.3 Burden 
39 
12.4 Potential for distress 
40 
12.5 Non coercive recruitment strategy 
40 
12.6 Confidentiality 
40 
12.7 Lone working 
40 
12.8 Peer review 
41 
12.9 Financial and other competing interests 
41 
12.11 Access to the final study dataset 
41 
13. PUBLIC AND PATIENT INVOLVEMENT ...................................................................................... 41 
15. EQUALITY AND DIVERSITY STATEMENT ................................................................................... 43 
REFERENCES ................................................................................................................................... 45 
 
 
 
 

 
 
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iii. TRIAL SUMMARY 
Trial Title 
Understanding factors which affect willingness to self-
manage a pessary for pelvic organ prolapse: A mixed 
methods study aiming to improve access to pessary self-
management. 
Internal ref. no. (or short title) 
B01328 What affects willingness to self-manage a pessary? 
Trial Design 
Mixed methods 
Trial Participants 
Quantitative phase Pessary using women at Manchester University NHS 
Foundation Trust 
Qualitative phase Pessary using women at Manchester University NHS 
Foundation Trust 
Intervention development group Pessary using women identified via the Royal College of 
Obstetricians and Gynaecologists (RCOG) Women’s voices 
group 
Pessary practitioners  
Expert review Members of UK Clinical Guideline: for best practice in the use 
of vaginal pessaries for pelvic organ prolapse committee 
Pilot Pessary using women at Manchester University NHS 
Foundation Trust who do not have experience self-managing 
their pessary 
Planned Sample Size 
Quantitative phase 90 pessary using women 
Qualitative phase 10-15 pessary using women 
Intervention development group A combination of 10-17 pessary using women and pessary 
practitioners 
Expert review Sent to all UK pessary guidelines group committee members 

 
 
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Pilot 5-10 pessary using women  
Duration 
18 months 
Research objectives 
 
• To explore how the lived experience of being a 
woman affecting willingness to self-manage a pessary 
for pelvic organ prolapse 
• To co-create an intervention to better support 
women to feel willing and able to self-manage their 
pessary 
 
iv. FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
FINANCIAL AND NON FINANCIAL SUPPORT 
GIVEN 
Health Education England (HEE) / National 
Institute for Health Research (NIHR) 
Lucy Dwyer, Clinical Doctoral Research Fellow, 
NIHR300519 is funded by Health 
Education England (HEE) / National Institute for 
Health Research (NIHR) for this research project 
 
v. ROLE OF TRIAL SPONSOR  
Manchester University NHS Foundation Trust are the sponsor and therefore assume overall 
responsibility for the initiation and management of the research. The sponsor will undertake this role 
through: 
 
• Undertaking proportionate peer review of the proposed study 
• Reviewing and ensuring all appropriate, valid supporting documentation is supplied to the 
necessary approval bodies at the point of application 
• Ensuring the division of roles and responsibilities are clearly defined and signed off prior to the 
study commencing 

 
 
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• Undertaking the appropriate level of monitoring and audit proportionate to the study and 
ensuring the necessary level of oversight throughout the life cycle of the study 
• Ensuring an agreed risk assessment process is in place to identify any potential risks to the 
organisation or the health, safety and well-being of researchers and research participants 
• Ensuring that patients and/or public have been involved in study design 
• Ensuring the CI has the relevant experience and appropriate training to fulfil their role  
• Ensuring the study is registered on an accessible database  
• Ensuring all findings are disseminated/published in an appropriate manner and intentions are 
made clear at the time of application 
 
vi. KEY WORDS: 
Self-management, Self-care, Prolapse, Pessary, 
Willingness  
 
 
 

 
 
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vii. TRIAL FLOW CHART 
 
  
 
Qualitative phase 
10-15 pessary using 
women 
Approached about the 
study-information pack 
provided 
Informed consent to 
participate in the study 
obtained 
Data collection 
End of study participation 
Focus groups 
7-12 pessary using women 
4-5 pessary practitioners 
Approached about the 
study-information pack 
provided 
Informed consent to 
participate in the study 
obtained 
Sent findings of qualitative 
phase to review and 
consider 
Invited to participate in 
focus group 
2 to 3 focus group 
sessions (depending upon 
progress) 
 
End of study participation 
 
 
Co-creation intervention development 
Clinical development 
Observations of 
discussions about pessary 
self-management in 
clinical setting 
Expert pessary practitioner 
review and feedback of 
intervention developed 
Piloting of intervention with 
5-10 pessary using women 
asked to offer feedback on 
the intervention via oral 
feedback 
Final intervention as 
research output 
Submit substantial 
amendment to clarify what 
the intervention consists of 
Quantitative phase 
90 pessary using women 
Approached about the 
study-information pack 
provided 
Implied consent 
demonstrated by 
questionnaire completion 
Asked to leave details if 
willing to receive 
information about interview  

 
 
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1. BACKGROUND 
There is a lack of evidence regarding factors which affect willingness to self-manage a pessary, 
including which are significant and whether this differs between women. Understanding these factors 
will enable development of resources to help women self-manage their care. Women should have the 
option of clinician-led care or self-management of their pessary. However, self-management of a 
pessary is discussed with women much less frequently in the UK than other countries, the reasons for 
this are unclear (Dwyer et al, 2022). Many factors which affect willingness to self-manage could 
potentially be overcome with tailored support, education and helping women to change perceptions. 
While patients should not be forced to self-manage, nurses have a duty to facilitate individuals to self-
manage their health and enable this as far as possible (Nursing and Midwifery Council, 2018). Patients 
with other long-term health conditions such as diabetes or asthma receive support and education to 
ensure they are motivated and confident to take responsibility for their health (Barlow et al., 2002). 
This support is not currently available for pessary users. 
 
Pelvic Organ Prolapse (POP) is downward displacement of the uterus, vaginal compartments and/or 
their neighbouring organs (Haylen et al., 2016). Pelvic organs are supported by pelvic floor muscles 
and weakness in these muscles may result in POP (Schaffer et al., 2005). While not life threatening, 
POP can severely impact upon a woman’s quality of life through bowel or bladder symptoms, 
discomfort, impact upon self-image and sexual dysfunction (Haylen et al., 2016). The lifetime risk of a 
parous woman having POP surgery in the UK is 10% (Abdel-Fattah et al., 2011). 
 
Surgical management of POP is an option, however some women wish to avoid or delay surgery and 
others may not be medically fit (Gorti et al., 2009). For these women, mechanical support of POP 
through by a vaginal pessary provides alternative, effective management (Cundiff, 2000). There are 
various types of pessaries available, with size and style being the main factors for the clinician to 
consider (Atnip, 2009). Pessaries can be categorised as a support pessary (ring) or a space filling 
pessary (Gellhorns or Cube) (Thakar and Stanton, 2002). Standard pessary follow-up tends to be 
biannual (Gorti et al., 2009), requiring significant healthcare resources as well as being burdensome 

 
 
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for women (Kearney and Brown, 2014). Regular long-term follow-up may be the reason some women 
opt for surgery (Kearney and Brown, 2014). Pessary follow-up entails removal of the pessary, and 
speculum examination of vaginal tissue to ensure the pessary has not caused damage. 
 
Pessary self-management is the woman’s ability to remove and reinsert their pessary. In addition to 
potentially reducing the burden of attending as many hospital appointments, self-management offers 
women autonomy regarding how to use a pessary. 
 
Through in-depth interviews with pessary using women, this study aims to develop greater 
understanding of the lived experience of being a woman and how this may affect willingness to self-
manage a pessary for prolapse. Utilising these findings, pessary using women and pessary 
practitioners will co-create an intervention to better support women to overcome barriers to pessary 
self-management. 
 
2. RATIONALE 
A scoping review undertaken by the chief investigator (Dwyer et al, 2022) suggests pessary self-
management offers benefits to some women  (Kearney and Brown, 2014, Hanson et al., 2006) with no 
increased risk of complications (Manchana, 2011, Lammers et al., 2019, Daneel et al., 2016, 
Morcuende et al., 2018, Holubyeva et al., 2021). It is clear some women do not feel willing or able to 
self-manage their pessary (Clemons et al., 2004a, Clemons et al., 2004b, Chen et al., 2020, Storey et 
al., 2009, Jacobs and Banks, 2010, Murray et al., 2017, Chan et al., 2019, Tam et al., 2019, Holubyeva 
et al., 2021, Wu et al., 1997, Ramsay et al., 2011, Manchana, 2011, Nemeth et al., 2013, Kearney and 
Brown, 2014, Pizarro-Berdichevsky et al., 2016, Daneel et al., 2016, Hooper et al., 2018, Thys et al., 
2020, Lammers et al., 2019). However, it is uncertain whether increased support to help women 
overcome these issues or concerns may address this. The results of the scoping review have 
demonstrated that there is a lack of understanding about factors that affect willingness to self-
manage a pessary other than brief references to physical inability, insufficient confidence and the 
intimate nature of pessary management requiring a woman to touch their genitals (Dwyer et al, 

 
 
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2022). The scoping review also confirmed there are certain factors which affect the likeliness of 
pessary self-management. However, it is currently not clear whether these factors increase 
willingness to self-manage a pessary or instead affect access or ability to self-manage a pessary. This 
gap in the evidence, and therefore our understanding of willingness to self-manage a pessary 
prevents pessary practitioners from better supporting women to overcome these barriers to self-
management. Therefore, in-depth exploration of factors that affect willingness to self-manage a 
pessary is required. It may also be necessary to determine the barriers most frequently reported by 
women, in order to prioritise where to focus additional support or interventions to help women 
overcome perceived barriers, with the aim of increasing, and ensuring, equitable access to pessary 
self-management. 
 
3. OBJECTIVES  
3.1 Research aims 
• 1. To gain a deeper understanding of factors affecting a woman’s willingness to self-manage a 
pessary for POP 
• 2. To explore how the lived experience of being a woman may impact willingness to self-
manage a pessary for POP  
• 3. To use these findings to better support women to self-manage a pessary for POP 
3.2 Research objectives 
• 1. To conduct in-depth interviews with pessary using women to gain a deeper understanding 
of factors which affect their willingness to self-manage a pessary for POP 
• 2. To co-create an intervention to support self-management of a pessary for POP 
3.3 Hypothesis 
The lived experience of being a woman affects how willing women are to self-manage a pessary for 
pelvic organ prolapse. 

 
 
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4. METHODOLOGY 
This study consists of three phases; firstly data gathering to explore the lived  experience of pessary using 
women and how this may affect willingness to self-manage a pessary for POP; secondly co-creation of an 
intervention to support women to self-manage a pessary for POP and thirdly piloting the intervention to assess 
the clinical feasibility and utility of it. Women will be recruited from pessary clinics in the women’s outpatient 
department at Manchester University NHS Foundation Trust for the first and third phase. For the co-creation 
phase, pessary using women and pessary practitioners will be identified by the Royal College of Obstetricians 
and Gynaecologists (RCOG) Women’s Network Co-ordinator who will approach pessary using women who are 
members of the RCOG Women’s Voice’s Network. The RCOG Women’s Voices Network is a group of over 600 
women with personal experience of women’s health issues who are willing to be approached about 
involvement in research. The maximum total sample size is 132 women though this may reduce depending 
upon data saturation. 
 
4.1. Mixed methods methodology 
Utilising a mixture of both qualitative and quantitative research through triangulation offers the opportunity to 
collaborate, elaborate or initiate findings (Rossman and Wilson, 1985). Collaboration refers to the convergence 
of findings collected via different methodological approaches to test reliability, elaboration is the generation of 
rich data to expand upon initial findings and initiation, the provocation of further thinking and questioning of 
findings  (Rossman and Wilson, 1985). A mixed methods approach has been chosen to explore the factors 
which affect willingness to self-manage a pessary for POP  with the aim of collecting rich accounts of women’s 
lived experience of being a woman and how that affects their using a pessary for pelvic organ prolapse and 
their thoughts and experiences of pessary self-management. An explanatory mixed methods approach will 
enable the researcher to collect data from a large group of pessary using women which can be analysed to 
explore whether demographics, patient characteristics or self-image of the genitals is correlated with 
willingness to self-manage a pessary for prolapse. The findings of the quantitative phase will inform the 
qualitative phases by providing details about a group of women of varying characteristics and opinions about 
self-management who can then be sampled for the interviews to ensure stratified random sampling. 
Furthermore, findings of the quantitative phase which affect willingness to self-manage a pessary can be 
explored in greater detail during interviews as part of the qualitative phase. For example, if it is identified that 

 
 
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older women completing the questionnaire are less likely to be willing to self-manage their pessary, this will 
inform the questions to be asked. Moreover, offering women who may not feel comfortable being interviewed 
the opportunity to participate if they wish, by completing an anonymous questionnaire ensures different levels 
of involvement are possible. Furthermore, establishing whether female genital self-image, which can be 
reliably determined using a four-item questionnaire, is correlated with willingness to self-manage a pessary, 
may have clinical utility as it may help clinicians to target the intervention we plan to develop at those who are 
most likely to benefit from it.    
 
4.1.1 Quantitative methodology 
The Quantitative phase will be a simple cross-sectional descriptive design with the aim of collecting descriptive 
data about pessary using women’s attitudes towards pessary self-management and establishing whether there 
appears to be a relationship between that and demographics, patient characteristics or self-image related 
specifically to their genitals (Gray and Grove, 2021).  
 
4.1.2 Qualitative methodology 
Qualitative methodology underpinned by phenomenology and an embodied enquiry approach to 
collect data will be used. Phenomenology offers a comprehensive insight into the nature, structures 
and meaning of the lived experience (Zeiler and Käll Folkmarson, 2014, Gray and Grove, 2021). A 
phenomenological approach takes into consideration environmental influences and the meaning 
which individuals have made from these external influences which have shaped our actions, beliefs 
and relationships (Gray and Grove, 2021). This research aims to generate rich accounts of the 
phenomenon of pessary self-management by developing understanding of the lived experiences of 
pessary using women and how past experiences have influenced their decision making about pessary 
self-management. Therefore, a phenomenological methodology is suitable for the purpose of this 
research (Smith and Shinebourne, 2012).  
 
Philosophical approaches to the analysis of phenomenological research can be defined as either 
descriptive or interpretative (Matua and Van Der Wal, 2015). A descriptive phenomenological 

 
 
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approach aims to describe a phenomenon from the perspective of experts living it, avoiding any 
influence from the researcher who must disregard any prior opinions, views or experience (Matua 
and Van Der Wal, 2015). An interpretive approach to phenomenology aims to gain understanding or 
meaning from the experiences described my experts living the phenomenon (Matua and Van Der Wal, 
2015). Interpretative phenomenologists acknowledge that the researcher’s opinions and perspectives 
may influence interpretation of findings, but argue it is not possible to ‘unknow’. Therefore, it is 
proposed instead that researchers record their opinions, views and perspectives and how these 
change during the course of data collection and analysis, via a reflexive diary (Engward and Goldspink, 
2020). An interpretive phenomenological approach is suitable for this research proposal as it aims to 
develop an understanding of how the lived experience of being a woman influences willingness to 
self-manage a pessary, therefore requiring interpretation of the meaning of being a woman from the 
data collected in interviews (Matua and Van Der Wal, 2015).   
 
A feminist approach to phenomenological research has previously been utilised to provide detailed 
description of uniquely female experiences (Zeiler and Käll Folkmarson, 2014). A feminist approach to 
phenomenological research ensures a focus on women’s’ perceptions and experiences of sexuality, 
power relations, privilege, social norms, cultural practices, bodies and desires in a society shaped by 
men (Zeiler and Käll Folkmarson, 2014). POP, pessary management and self-management of a pessary 
for POP are uniquely female experiences. 
 
Embodied inquiry is a research approach which promotes the use of different and creative methods 
to gain greater insight into embodied, lived experience (Leigh and Brown, 2021). Embodied inquiry is 
suitable where the human body is central and integral to the research question, or where verbal 
communication may be insufficient to fully explore an issue (Leigh and Brown, 2021). An embodied 
inquiry approach facilitates the gathering of data which cannot be expressed using words using art-
based, dramatic or physical methods (Leigh and Brown, 2021). 
 

 
 
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Therefore, a feminist phenomenological methodology with an embodied inquiry approach will 
consider sociological, cultural and historical influences upon women and how this influences 
willingness to self-manage a pessary. Feminist phenomenology will be used to ensure qualitative data 
collected provides in-depth understanding of the lived experience of women and how this may affect 
their willingness to self-manage a pessary.  
 
4.2 Intervention development methodology 
Following data collection, the project will proceed to the development of an intervention to meet the 
needs of pessary using women approached about self-management, to support them to overcome 
barriers they experience. A three stage intervention co-production framework (Hawkins et al., 2017), 
Medical Research Council (MRC) complex intervention development guidelines (Skivington et al., 
2021) and Normalisation Process Theory (NPT) theory (Murray et al., 2010) will be utilised to inform 
and guide the process.  
 
The first stage requires a review of relevant evidence and stakeholder consultation (Hawkins et al., 
2017). Therefore, relevant literature and data collected in the qualitative phase will provide required 
evidence of the problem and target population. Depending on what the factors are that have been 
identified by women as potentially supporting or enabling them to self-manage their pessary, pessary 
using women will be asked to consider the types of intervention or support which may be most 
helpful. Furthermore, as advocated by Hawkins et al. (2017) observations of current practice in 
discussing pessary self-management will be undertaken to identify what support is currently being 
offered and how it is received and responded to by women. 
 
In the second stage where the intervention will be co-created, an intervention development group 
will be established consisting of members of the research team and key stakeholders. Over a series of 
meetings the intervention development group will use an action research cycle approach of assessing 
the findings of stage one, asking members of the group to propose ideas of how pessary using women 
can be better supported to overcome barriers to willingness to self-manage, seeking feedback on 

 
 
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ideas, refining proposed ideas and gaining feedback again (Hawkins et al., 2017). Once the group are 
satisfied with the proposed support intervention, the development process will move to the final 
stage of prototyping (Hawkins et al., 2017). In this stage, expert pessary practitioners will be asked to 
review and provide feedback on the content and delivery of the proposed intervention as well as any 
associated documents. To test the intervention, it will be piloted amongst a small number of pessary 
using women to ensure usability, feasibility and obtain any further feedback about intervention 
delivery in a real world setting. 
    
5. QUANTITATIVE PHASE STUDY DESIGN 
5.1 Quantitative phase setting 
Women will be recruited from the pessary clinic at Manchester University NHS Foundation Trust and 
if willing to participate will be asked to complete a short questionnaire either in the hospital waiting 
room, or at home to return via post if preferred. 
 
5.2 Quantitative phase inclusion criteria 
• Willing and able to give implied consent by completion of the questionnaire 
• Female 
• Over the age of 18 years  
• Have retained a pessary for pelvic organ prolapse for a minimum of two weeks 
• Able to speak and understand English  
• Use a ring, shaatz, cube or inflatable pessary 
 
5.3 Quantitative phase exclusion criteria 
• Lacking capacity to give implied consent by completion of the questionnaire 
• Has a first or preferred language that is not English  
• Use a shelf, gell-horn or donut pessary 
 

 
 
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The convenience sample of women will be pessary using women who are attending a pessary clinic 
appointment in the women’s outpatient department at Manchester University NHS Foundation Trust. 
While the limitations of a convenience sample are recognised, because such a large number of 
women attend the pessary clinic each week, it is anticipated that characteristics which may impact 
upon willingness to self-manage a pessary as identified in the scoping review such as pessary type, 
age, menopausal status, level of education, being sexually active, experience of pessary management 
and health status (Dwyer et al, 2022) will be represented within the sample (Gray and Grove, 2021). 
 
5.4 Quantitative phase participant identification 
The study will be introduced to women receiving pessary management for a prolapse in the women’s 
outpatient department at Manchester University NHS Foundation Trust. Upon checking in for the 
clinic at the reception desk women will be given an information pack which explains the study.  
 
5.5 Quantitative phase consent 
For the quantitative phase, informed consent to participate will be indicated by completion of the 
questionnaire. The questionnaire does not require participants to provide any identifiable information 
unless they would be willing to receive further information about the qualitative phase. Should 
women wish to discuss any aspect of participation, before or after completing the questionnaire, they 
will be provided with the chief investigator’s contact details or can speak with a member of the 
clinical team in the department. A participant information sheet reviewed by the Sponsor, REC and 
HRA will be given and read by all participants before they choose whether to complete the 
questionnaire.  
5.6 Quantitative phase payment/reimbursement  
There will be no payment or reimbursement for participation in the quantitative phase due to the 
short amount of time it is anticipated that completion of the questionnaire will take and the fact that 
it will be completed by women already attending the hospital. Therefore, no inconvenience will be 
experienced by the woman having to travel to the hospital. Should women wish to complete the 

 
 
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questionnaire at home and return it via post, they will be given a stamped addressed envelope to 
ensure they incur no costs as a result of study participation.  
 
5.7 Quantitative baseline data 
Descriptive data about the women who are participating in the research will be collected by the 
researcher from the woman and recorded on a paper case report form. 
• Year of birth 
• Length of time pessary used for 
• Type and size of pessary in situ 
• Comorbidities 
• Self-management status 
• Self-management experience 
• Self-management willingness 
• Ethnicity 
• Post code 
• Level of education 
• Female Genital Self-Image Score (FGSIS) 
 
5.8 Quantitative phase data collection 
Data collection will be completion of a questionnaire which requests information about the woman’s 
demographics, pessary use, self-management experience, willingness to self-manage and a free text box 
to express thoughts about pessary self-management. Women will also be asked to complete the Female 
Genital Self-Image Scale (FGSIS-4), a reliable and validated  4-item questionnaire which measures 
women’s attitude and beliefs about their genitals (Herbenick and Reece, 2010). 
  

 
 
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5.9 Quantitative phase sample size  
The distribution between willingness to self-manage a pessary and FGSIS-4 has not yet been established. 
Therefore, based upon statistical advice we have calculated the sample size for a medium effect size of 
0.3, for a chi squared test on a two by two table (self-management vs FGSIS). With 5% significance level a 
sample of 90 will have 80% power to detect a medium effect size of 0.3 (Cohen, 1988). Therefore, based 
upon this, we aim to recruit 90 women to the quantitative phase. 
 
5.10 Quantitative phase data analysis  
Data collected in the questionnaires will be analysed to provide descriptive statistics about the 
women who have completed the questionnaire, their experience of self-management and willingness 
to be interviewed in the qualitative phase. Free text data will also be analysed for the emergence of 
themes and coded to explore whether there are any patterns that emerge between women of similar 
characteristics with regards to willingness, or not, to self-manage a pessary. Statistical analysis will be 
performed by a statistician to test for correlation between demographics, patient characteristics and 
FGSIS-4 scores and willingness to self-manage a pessary for prolapse. Scores in the FGSIS-4 range 
between 4-16, with a mean score of 12 in a nationally representative population of over 2000 
American women (Herbenick et al., 2011). Herbenick et al. (2011) have not determined a binary score 
for high and low FGSIS, however for the purpose of this study, a score of eight or less will indicate low 
FGSI, whereas more than eight will indicate high FGSI. To score eight or less, a participant must 
disagree with all four statements describing genital self-image therefore this is deemed to accurately 
represent FGSIS-4.    
 
5.11 Quantitative phase outputs  
The output from the quantitative phase will be summary of the women who participated in the 
quantitative phase, their experience and opinions about pessary self-management and the results of 
the FGSIS. The findings will also inform sampling for the qualitative phase, as the chief investigator 
will ensure a stratified sample based upon characteristics, opinions and experience of pessary self-
management as well as the FGSIS score. This will ensure the sample in the qualitative phase will be 

 
 
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representative and provide rich data. Collecting quantitative data from women who are not willing to 
be interviewed about their beliefs ensures these women have the opportunity to express their 
thoughts and opinions about pessary self-management. 
 
6. QUALITATIVE PHASE STUDY DESIGN 
6.1 Qualitative phase setting 
Women will be recruited from the pessary clinic at Manchester University NHS Foundation Trust and 
interviewed in person either at the hospital or an alternative venue if preferred, or via video 
consultation using the ‘Attend anywhere’ secure technology utilised at Manchester University NHS 
Foundation Trust for clinical appointments. 
 
6.2 Qualitative phase inclusion criteria 
• Willing and able to give informed consent 
• Female 
• Over the age of 18 years  
• Have retained a pessary for pelvic organ prolapse for a minimum of two weeks 
• Able to speak and understand English or, for those whose first or preferred language is a 
language other than English, speak a language with an available interpreter  
 
6.3 Qualitative phase exclusion criteria 
• Lacking capacity to give informed consent 
• Has a first or preferred language that is not English, or a language without an available 
interpreter  
 
The criterion sample of women will be pessary using women who receive pessary care at the 
women’s outpatient department at Manchester University NHS Foundation Trust. In order to ensure 
a rigorous approach to sampling, criterion sampling will be used whereby all women will have a 
shared experience of the phenomena of using a pessary (Gray and Grove, 2021). However, to ensure 

 
 
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a stratified sample, women who have certain characteristics of interest identified during the 
quantitative phase (for example age, high or low FGSIS scores) and indicated a willingness to receive 
information about the qualitative interviews will be sent information about the qualitative phase to 
consider. 
 
6.4 Qualitative phase participant identification 
The study will be introduced to women receiving pessary management for a prolapse in the women’s 
outpatient department at Manchester University NHS Foundation Trust. If identified while attending 
the hospital, a clinician will approach the woman and give them an information pack. The CI will also 
identify women for study participation by screening MFT pessary clinic lists or who have expressed 
willingness to receive information about the qualitative phase when participating in the quantitative 
phase. In this instance the study information pack will be posted out to these women by the chief 
investigator. Following receipt of the information, the woman will be asked to confirm willingness to 
be interviewed by the investigator by completing and returning an expression of interest form. The 
investigator will then arrange an appointment for the woman at a convenient time. For women who 
require a language interpreter, the interview will need to be conducted at MFT to ensure access to 
the hospital interpretation service, or via video consultation. 
 
6.5 Qualitative phase consent 
For the qualitative phase, informed consent will be obtained by the chief investigator. The chief 
investigator will have completed recent Good Clinical Practice training as per the Sponsor’s 
requirements. During the informed consent process, a discussion will take place between the 
potential participant and the chief investigator about the research, the nature and objectives of the 
study and possible risks associated with their participation. Potential participants will also be given 
the opportunity to ask any questions they have. A participant information sheet reviewed by the 
Sponsor, REC and HRA will be given and read by all participants before written informed consent is 
obtained. Capacity to give informed consent will be assessed by a member of the research team in 
accordance with training to assess capacity provided by the sponsor. For women who choose to have 

 
 
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a face to face interview, informed consent will be obtained via a paper consent form. For women who 
prefer to have their interview conducted remotely via ‘attend anywhere’, the informed consent 
process and verbal consent will be video recorded following permission from the woman prior to the 
call. The consent to record will be confirmed before and after pressing Record. The video recording 
will be stored securely on the chief investigator’s password protected account on the MFT NHS 
hospital server. The chief investigator will obtain recorded verbal agreement to each point on the 
consent form. Remote participation in the interview also acts as confirmation that the participant is 
willing to continue in this way. Following the informed consent process, the video recording will be 
stopped and the audio recording commenced. The video recording of confirmation will be emailed 
securely to each participant. If the recording is lost or fails, the woman will be contacted again and 
asked to sign a paper consent form either in person (if preferred), or via post, in which case a consent 
form will be posted to her with a stamped, addressed envelope. If returned via post, the consent form 
will be signed by the researcher upon receiving the consent form signed by the woman. The consent 
date for the researcher will be the date the form is received in the post. The consent process, whether 
face to face or during video consultation as well as any need to re-consent will be documented in the 
woman’s hospital records. 
6.6 Qualitative phase payment/reimbursement  
• £10 shopping voucher following interview  
• £10 shopping voucher upon receipt of a photograph or presentation of participant’s identity 
box 
Maximum total £20 
 
6.7 Baseline data 
Descriptive data about the women who are participating in the research will be collected by the 
researcher from the woman or medical records if necessary (for example if a woman isn’t sure of the 
type or size of her pessary) and recorded on a paper case report form). Should the woman have 

 
 
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previously completed a questionnaire in the quantitative phase, this data will be verified with the 
woman, but will not need to be collected again if still correct. 
• Year of birth 
• Length of time pessary used for 
• Type and size of pessary in situ 
• Comorbidities 
• Self-management status 
• Self-management experience 
• Self-management willingness 
• Ethnicity 
• Post code 
• Level of education 
• Female Genital Self-Image Score (FGSIS) 
 
6.8 Qualitative phase data collection 
Data collection will be via semi-structured interviews. An interview guide will be used to structure the 
interviews. This guide has been developed based upon findings of a scoping review and systematic 
review undertaken by the chief investigator in addition to wider reading of similar studies exploring the 
lived experience of being a woman from a feminist perspective. The interviews will be conducted by the 
chief investigator either in person or via video consultation depending upon the participants’ preference. 
The interviews will be audio recorded, anonymised and transferred to a professional transcription service 
by their encrypted file transfer page. Upon receipt by the professional transcription service, the audio 
recording will be transcribed verbatim then returned to the researcher for coding. The chief investigator 
will also make field notes recording observations, emerging themes and concepts, methodological issues 
and a summary of the data collected and how this contributes towards research findings (Groenewald, 
2004).   
 

 
 
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An embodied enquiry approach will also be utilised whereby data will also be gathered by asking 
participants to collect an identity box prior to the interview which reflects their physical, psychological 
and emotional experiences of having prolapse, using a pessary or self-management of a pessary. 
Women will be asked not to include any items which would identify themselves or anyone else for, 
example by including personal photos or using names. The women will be asked to take a photograph 
of the identity box or bring the identity box to the interview if preferable and convenient in which 
case the researcher will take a photograph of the identity box. The researcher will engage the woman 
in discussion about the contents of their identity box to ensure understanding of how the items 
reflect their lived experience. Photographs of the identity boxes will be used in the dissemination of 
findings to further illustrate women’s physical, psychological and emotional experiences which cannot 
be explained using spoken word.  
 
6.9 Qualitative phase sample size  
Phenomenological research typically requires a sample size of less than ten prior to data saturation 
(Moser and Korstjens, 2018). Therefore, a provisional sample size of 10-15 women has been 
established with awareness that this may be reduced or increased depending upon informational 
redundancy. Consensus will be sought from the supervisory team and pessary user members of the 
project management group to ensure all agree saturation of data has occurred and that the themes 
identified accurately reflect the lived experience of pessary users.  
 
6.10 Qualitative phase data analysis  
The process of making field notes represents the commencement of data analysis, as reflecting upon 
the data collected, the meaning derived from this, how it directs future data collection and fits with 
previous data collected is analysis (Groenewald, 2004). Formal analysis of the collected data will be 
undertaken using an interpretive phenomenological approach described by Smith and Shinebourne 
(2012). The first step is becoming immersed in the interview transcript to ensure familiarity with the 
findings, making notes and annotations as required (Smith and Shinebourne, 2012). After this, the 
transcript will be re-read and emerging themes noted (Smith and Shinebourne, 2012). The next stage 

 
 
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is to look for connections between the themes identified within the transcript and create clusters 
while constantly referring to the original transcript to verify interpretations being made (Smith and 
Shinebourne, 2012). The final stage of transcript analysis is to create a table of themes, structured to 
prioritise themes rich in evidence and which accurately reflect the interview (Smith and Shinebourne, 
2012). Clusters will be renamed to reflect the superordinate and subordinate themes recorded within 
them (Smith and Shinebourne, 2012). The step by step process will be utilised for the analysis of 
further transcripts, however the researcher will use the analysis of prior transcripts to examine 
whether there are similarities and differences in the data gathered from women (Smith and 
Shinebourne, 2012). Once each transcript has been analysed, a master table of superordinate and 
subordinate themes identified within the whole data set will be created (Smith and Shinebourne, 
2012). Smith and Shinebourne (2012) clarify that themes should be included and prioritised within the 
table based upon the richness of data supporting the theme and how accurately it reflects the 
accounts given by participants rather than the frequency of which they are identified. In accordance 
with the feminist approach the chief investigator will consider whether the themes identified 
represent gender differences or power imbalances acknowledging the structural implications of 
society, culture and politics for being a woman (Clifford et al., 2019).   
 
6.11 Qualitative phase outputs  
The output from the qualitative phase will be rich accounts of the lived experience of being a woman 
and how this has influenced willingness to self-manage a pessary for POP, a list of factors that affect 
willingness to self-manage a pessary identified within the rich data and photograph images of the 
identity boxes with a text description of the items included and the meaning placed upon these items 
by women. 
 

 
 
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7. INTERVENTION DEVELOPMENT PHASE STUDY DESIGN 
7.1 Intervention development phase setting 
The intervention will be co-created by pessary using women and pessary practitioners. Intervention 
development meetings will be held virtually to facilitate attendance without travel, minimising 
inconvenience to attendees.  
 
7.2 Intervention development phase inclusion criteria 
Pessary using women 
• Willing and able to give informed consent 
• Female 
• Over the age of 18 years  
• Have retained a pessary for pelvic organ prolapse for a minimum of two weeks 
• Able to speak and understand English  
 
Pessary practitioners 
• Willing and able to give informed consent 
• Provide regular pessary care as part of clinical role (defined as insertion or removal of a 
woman’s pessary on a minimum of a monthly basis)   
• Able to speak and understand English  
 
7.3 Intervention development phase exclusion criteria  
Pessary using women 
• Lacking capacity to give informed consent 
• Does not speak or understand English 
 
Pessary practitioners 
• Lacking capacity to give informed consent 
• Does not speak or understand English 

 
 
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• Does not provide pessary care at a minimum of a monthly basis   
 
A purposive sample of pessary practitioners will be identified by the chief investigator taking into 
account different professions, pessary practitioner experience, different types of care settings and 
other factors which may influence their opinions of pessary practice and pessary self-management. 
 
7.4 Intervention development phase participant identification 
The RCOG’s Women’s Network have agreed to support identification of pessary using women from 
members of their organisation using their social media accounts on Instagram, Facebook, Twitter, in 
addition to email contacts of women who have previously expressed an interest in being informed of 
involvement opportunities and given permission to be contacted with information about upcoming 
projects. Standard text which has been developed by the chief investigator and the RCOG Patient and 
Public Involvement manager will be shared via email distribution to the Women’s network members 
who have previously consented to receiving such communications. The standard text will also be 
shared via posts on the RCOG’s Instagram, Facebook, Twitter accounts.  
 
Potential pessary practitioner participants will be identified by asking specialist organisations in 
Urogynaecology such as the RCOG and British Society of Urogynaecology to share an invitation letter 
via email with their members. 
 
7.5 Intervention development phase payment/reimbursement for pessary using women 
• £110 per meeting attended (costed at half a day in accordance with INVOLVE guidelines to 
allow for time to prepare for the meeting) 
Maximum total £330 per pessary using woman participant  
 
7.6 Intervention development phase consent 
For the intervention development phase, prior to the first meeting, all potential participants will be 
provided with an information sheet containing details of the co-creation process to ensure they are 

 
 
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able to make an informed decision. The chief investigator’s contact details will be included to enable 
potential participants to ask any questions they might have. Before the first intervention development 
meeting, the chief investigator will arrange to conduct a video consultation with each participant 
using ‘attend anywhere’ to obtain informed consent.  Following discussion of the study and the 
opportunity to ask any questions, the participant will be asked to confirm verbal consent which will be 
video recorded following permission from the participant at the start of the call. The video recording 
will be stored securely on the chief investigator’s password protected account on the MFT NHS 
hospital server. Following the informed consent process, the video recording will be stopped. If the 
recording is lost or fails, the woman will be contacted again and asked to sign a paper consent form 
and return it via the post in the a stamped, addressed envelope provided. The consent form will be 
signed by the researcher upon receiving the consent form signed by the woman. The consent date for 
the researcher will be the date the form is received in the post. It is not deemed necessary to reobtain 
consent prior to each subsequent meeting as the consent will cover research participation in its 
entirety. However, at the start of each meeting, the facilitator will remind attendees of important 
aspects of the meeting such as confidentiality and anonymity, as well as the importance of respecting 
and valuing everyone’s contributions to the meeting to ensure enduring consent. 
 
7.7 Intervention development phase data collection 
Descriptive data about the pessary using women and pessary practitioners who are participating in the 
research will be collected from the woman or pessary practitioner by the chief investigator completing a 
short questionnaire during the pre-meeting video consultation following informed consent being 
obtained.   
 
Data which will be collected from participants via the questionnaire includes the following information: 
Pessary using women 
• Year of birth 
• Length of time pessary used for 
• Type and size of pessary used (if known) 

 
 
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• Self-management status 
• Ethnicity 
• First or preferred language 
• Post code 
• Level of education 
 
Pessary practitioners 
• Year of birth 
• Ethnicity 
• Profession 
• Grade 
• Length of time providing pessary care 
• Experience providing pessary self-management support 
 
The intervention development meetings will be audio recorded and field notes taken as required. The 
audio recording will be transferred to a professional transcription service by uploading the file on to 
their encrypted file transfer page. Upon receipt by the professional transcription service, the audio 
recording will be transcribed verbatim then returned to the researcher for analysis. 
 
7.8 Intervention development sample size 
A sample size of between five and ten pessary using women, two additional pessary using women 
who are members of the project steering committee and three to five pessary practitioners has been 
decided upon based upon an informal review of similar intervention development processes. To 
ensure there are a sufficient number of attendees at each meeting, the required number of 
participants has been increased to create a range of participants. By approaching more potential 
participants than required, it is hoped that even with attrition, there will be a large enough number of 
attendees at each meeting.   
 

 
 
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7.9 Intervention development data analysis 
Baseline data of the pessary using women and pessary practitioners co-creating the intervention will 
be analysed to provide descriptive statistics of the population. The transcript of the intervention 
development meetings will be reviewed and reported to describe the iterative process of intervention 
development. Field notes made while observing discussions about pessary self-management in clinical 
practice will also be analysed thematically to identify recurring themes in the way pessary self-
management is discussed. 
 
7.10 Intervention development observation 
To develop an understanding of conversations between pessary using women and pessary 
practitioners, the chief investigator will observe several pessary clinics in the women’s outpatient 
department at Manchester University NHS Foundation Trust. While the chief investigator is a member 
of the clinical team who delivers pessary care here, due to her interest in pessary self-management 
she recognises that her clinical experience may not accurately reflect pessary using women and 
pessary practitioners typical conversations. Therefore, in order to bring this experience to the co-
creation process the chief investigator will observe pessary clinics with the agreement of pessary 
using women and the pessary practitioner providing care, making non-identifiable notes until she 
deems she has gained sufficient understanding and no further points of interest arise. The types of 
questions or concerns pessary using women express and the ways these are discussed by pessary 
practitioners will be relayed during the intervention development meetings to ensure the process is 
informed by real world data. In the instance of observing any poor practice, the chief investigator will 
use her nursing experience including being a qualified mentor, to address the situation appropriately, 
either immediately or following the consultation depending upon the urgency of the issue. Should the 
practice be sufficiently concerning, the practitioner’s line manager will be informed in accordance 
with the MFT ‘Raising Concerns at Work and Whistleblowing Policy’.     
 

 
 
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8. INTERVENTION PILOT PHASE STUDY DESIGN 
8.1 Intervention pilot phase setting 
Women will be recruited from the pessary clinic at Manchester University NHS Foundation Trust and 
if willing to participate, following their appointment would be asked to review the intervention and 
provide feedback via questionnaire or verbally at that time, or an appointment can be made for a 
later date if preferable.  
 
8.2 Pilot phase inclusion criteria 
• Willing and able to give informed consent, review the intervention and provide written and/or 
verbal feedback. 
• Female 
• Over the age of 18 years  
• Have retained a pessary for pelvic organ prolapse for a minimum of two weeks 
• Able to speak and understand English  
• Have no previous experience self-managing a pessary (defined as never having removed or 
inserted their pessary, or received any pessary self-management teaching or support from a 
healthcare professional)  
 
8.3 Intervention pilot exclusion criteria  
• Lacking capacity to give informed consent, review the intervention and provide written and/or 
verbal feedback. 
• Does not speak or understand English 
• Have prior experience self-managing a pessary (defined as previously removing or inserting 
their pessary, or receiving any pessary self-management teaching or support from a 
healthcare professional)  
 
For the intervention pilot, potentially eligible women will be given an information sheet explaining 
what participation in piloting the intervention entails. Informed consent will be obtained face to face 

 
 
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by the chief investigator who will ask participants to sign a written consent form to indicate their 
willingness to participate in the pilot study.  
 
8.4 Intervention pilot phase data collection 
Descriptive data about the women who are participating in the research will be collected by the 
researcher from the woman or medical records if necessary (for example if a woman isn’t sure of the 
type or size of her pessary). 
 
• Year of birth 
• Length of time pessary used for 
• Type and size of pessary used (if known) 
• Ethnicity 
• First or preferred language 
• Post code 
• Level of education 
 
Once baseline information has been collected from the woman by the chief investigator, the 
intervention will be provided to the woman and a timer started to record the length of time the 
intervention is utilised. The woman will be asked to identify any aspects of the intervention which 
were unclear or confusing (Gray and Grove, 2021). Any additional feedback about the intervention 
will be recorded in note form by the researcher on the paper case report form. 
 
8.5 Intervention pilot sample size 
Five to ten pessary using women identified via the pessary service at MFT will be recruited. Piloting 
the intervention tool aims to test the feasibility of the intervention, rather than measuring the 
outcome of it within a generalisable population. Therefore a sample size of five to ten is deemed to 
be sufficient (Gray and Grove, 2021). 

 
 
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8.6 Intervention pilot data analysis 
Baseline data of the group of women in the pilot study will be analysed to provide descriptive 
statistics of the population. The length of time it took the woman to utilise the intervention will be 
analysed and provided via descriptive statistics. Notes made about the women’s responses regarding 
whether the intervention was unclear or confusing and any additional feedback will be analysed for 
recurring themes and presented in text. 
 
9. END OF STUDY  
The end of the study is defined as the date the last participant recruited to the intervention pilot phase 
provides feedback on the intervention.  
 
10. DATA MANAGEMENT  
10.1 Data collection tools and source document identification 
All members of the research team will comply with the requirements of the Data Protection Act 2018 
with regards to the collection, storage, processing and disclosure of personal information and will 
uphold the Act’s core principles.  
• Hard copies of data will be held within a locked cupboard and locked office used by clinical 
members of the urogynaecology clinical team within Saint Mary’s Hospital. Electronic data 
will be held on the Chief Investigator’s personal drive on the secure MFT NHS hospital 
server. 
• Baseline data will be inputted in anonymised format on Excel.  
• Interview data will be audio recorded and anonymised with a linked participant 
identification number prior to transfer to a professional transcription service. The audio 
file will be saved electronically on the Chief Investigator’s personal drive on the secure 
MFT NHS hospital server.  A log containing the linked participant identification number and 
name will be held on the Chief Investigator’s personal drive on the secure MFT NHS 
hospital server. The audio files will be transferred via upload to the encrypted file transfer 

 
 
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page of a professional transcription service who will be required to sign a confidentiality 
agreement prior to transfer of data.  
• The intervention development meetings will be audio recorded. During the meetings it is 
likely that the first names of attendees will be used when addressing individuals as part of 
conversations and discussions. The first name alone will not enable identification of 
attendees. The audio files will be transferred via upload to the encrypted file transfer page 
of a professional transcription service who will be required to sign a confidentiality 
agreement prior to transfer of data. Once the audio recording has been transcribed, names 
will be removed and replaced with a pseudonym chosen by each participant. 
• The transcription service will hold the audio recordings on a secure encrypted database. All 
recordings and transcriptions will be deleted two weeks after receipt.   
• Once the audio recording has been transcribed, names will be removed and replaced with 
a pseudonym chosen by each participant.  
• Access to data will be restricted to the minimum number of individuals necessary for 
quality control, audit, and analysis as detailed in section 9.2. 
• The study data will remain the property of MFT.  A complete copy of the study data will be 
kept on the MFT secure IT server at the end of the study.  At the end of the study all 
documents and data relating to this project will be stored securely at MFT for 5 years 
following completion of the project, or in line with MFT policies and in accordance with ICH 
GCP. 
• The Chief Investigator will be the custodian for data generated by the study. 
 
10.2 Access to Data 
Direct access will be granted to authorised representatives from the Sponsor, host institution and the 
regulatory authorities to permit trial-related monitoring, audits and inspections in line with 
participant consent. 
 

 
 
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10.3 Archiving 
The study data will remain the property of MFT.  A complete copy of the study data will be kept on 
the MFT secure IT server at the end of the study.  At the end of the study all documents and data 
relating to this project will be stored securely at MFT for 5 years following completion of the project, 
or in line with MFT policies and in accordance with ICH GCP. 
 
11. MONITORING, AUDIT & INSPECTION 
The study will be subject to the audit and monitoring regime of Manchester University NHS 
Foundation Trust in line with applicable MFT SOPs and policies. The study will have, as a minimum, an 
annual survey sent out for completion by a member of the research team. 
 
12. ETHICAL AND REGULATORY CONSIDERATIONS 
12.1 Study approval 
NHS Research Ethics Committee (REC) and Health Research Authority (HRA) approval will be obtained 
prior to the study commencing. As it is unclear what the intervention will consist of, while overarching 
REC and HRA approval for the pilot phase is being applied for as part of the whole study, a substantial 
amendment will be submitted once the intervention has been developed but before the pilot phase to 
enable the REC and HRA teams to review the intervention and understand exactly what participants in 
the pilot phase are being asked. 
 
All correspondence with the REC and HRA will be retained in the site file. An annual report will be 
submitted to the REC by the chief investigator until the formal end of the study upon which the Chief 
investigator will notify the REC accordingly. Within a year of the study ending, the Chief investigator will 
ensure a final study report is submitted to the REC. 
 
Before the start of the study, a favourable opinion will be sought from an NHS REC for the study and all 
the supporting documents including the protocol, information sheets, informed consent forms and other 

 
 
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relevant documents. The study team will be responsible for the maintenance of a study site file, in which 
all current and superseded study documents will be retained. Also contained in the site file will be the 
approval documentation including correspondence with relevant authorities such as the HRA and REC. 
 
The study team are responsible for producing progress reports throughout the study, including annual 
reporting (APR) to REC as required. The Chief Investigator will notify the REC of the end of the study, and 
will submit a final report with the results, including any publications/abstracts, to the REC within 12 
months of the end of the study. If the study is ended prematurely, the Chief Investigator will notify the 
REC, including the reasons for the premature termination. 
 
No participants will be enrolled into this research study prior to the study being reviewed by the relevant 
regulatory authorities and receiving HRA and REC approvals, as well as approval from the R&D office at 
Manchester University NHS Foundation Trust. 
 
12.2 Amendments to the Protocol 
Any amendments to the to the study shall be reviewed by the sponsorship team prior to submission.  Any 
non-substantial amendments shall be notified to the HRA and any substantial amendments, along with 
amended documentation, shall be approved by the REC, and HRA, prior to implementation as per 
nationally agreed guidelines. The Chief Investigator or designee will work with the R&I department to put 
the necessary arrangements in place to implement the amendment and to confirm their support for the 
study as amended. 
12.3 Burden 
To minimise the burden of study participation, visits will be arranged at the woman’s convenience as far 
as possible. Participation in the qualitative and intervention development phases can be undertaken 
remotely via video call if preferred by the participant.  

 
 
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12.4 Potential for distress 
Due to the topic of the qualitative interviews there is potential for discussions related to body image, 
touching own genitals and other sensitive issues. This may distress participants. A study distress policy 
has been developed. The applicant has 11 years’ experience working within gynaecology including prior 
situations where disclosures related to abuse and other sensitive issues have arisen. Using this 
experience as well as skills and knowledge from relevant training, the applicant will be able to halt an 
interview if necessary and provide appropriate support or referral as indicated. 
12.5 Non coercive recruitment strategy 
It is an important principle of Good Clinical Practice that recruitment to research is non-coercive. 
Participants in the qualitative phase will be recruited from MFT and may have received clinical care 
from the applicant. It will therefore be clearly explained to potential participants that future clinical 
care will not be affected by study participation.  
 
12.6 Confidentiality 
Potential participants for the qualitative and pilot phases will be identified and approached by 
members of the direct clinical care team at MFT. If willing to discuss research participation, a member 
of the research team will provide written information and further details of the research. No 
participants will be identifiable in any data presented. During pessary clinic observations, should poor 
practice be observed which requires reporting, the identity of the pessary using woman will only be 
shared with the pessary practitioner’s line manager if required to enable investigation of the specific 
circumstance of the incident.    
 
12.7 Lone working 
Lone working policies from The University of Manchester and MFT will be followed including 
completion of a risk assessment to ensure appropriate controls are in place for the qualitative phase 
which involves interviewing participants at a location convenient and preferable to them 

 
 
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12.8 Peer review 
This study has been reviewed by the NIHR as part of the funding application, therefore further peer 
review is not deemed necessary. 
 
12.9 Financial and other competing interests  
This study is fully funded as part of the investigator’s HEE-NIHR Integrated Clinical Academic 
Programme Clinical Doctoral Research Fellowship. Lucy Dwyer and Rohna Kearney are co-applicants 
on the NIHR HTA TOPSY grant. There are no other competing interests.  
 
12.10 Indemnity 
The NHS indemnity scheme will apply to this study to ensure it meets the potential legal liability of the 
sponsor, equipment, employer and investigators/collaborators for harm to participants arising from the 
management, design and conduct of the research. No arrangements will be made for the payment of 
compensation in the unlikely event of harm.  
 
12.11 Access to the final study dataset 
The final anonymised electronic data set will be accessible to the investigator, academic and clinical 
supervisory team and statistician as required and stored on the chief investigator’s personal drive on 
the secure MFT NHS hospital server.  
 
13. PUBLIC AND PATIENT INVOLVEMENT  
The need for research exploring pessary self-management was highlighted by The James Lind Alliance 
(JLA) Priority Setting Partnership for pessary and prolapse (Lough et al, 2018). A number of women with 
experience of pessaries participated in this partnership either as members of the steering group, by 
attending the consensus workshop or completing questionnaires. Understanding more about self-
management including who can self-manage was ranked third out of 20 priorities by the JLA Priority 

 
 
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Setting Partnership. The research question has therefore been identified and prioritised by patients and 
members of the public. 
 
The proposal has been reviewed by the Urogynaecology user group at Saint Mary’s Hospital. Feedback 
provided confirmed that the research question was perceived to be of value and interest to the service 
users as well as acceptable in terms of study participation. The service user group agreed to provide 
further feedback upon the proposed research. 
 
The research proposal has also been reviewed by the Royal College of Obstetricians and Gynaecologist’s 
(RCOG’s) Women’s Network who supported funding of the project. This demonstrates that women 
support the research question, are in agreement with the methods proposed and are willing to 
participate in patient and public involvement for the study. 
 
A pessary using woman from The RCOG Women’s Network has reviewed and provided feedback on the 
study protocol, approval applications and study documents to ensure the research plan is ethical and 
answers the research question, that study documents are written clearly and to inform creation of the 
interview guide.  
 
Once recruitment commences, public members of the project steering group will be asked to contribute 
to discussions regarding the progress of the project and the course it is taking. This is particularly 
important for this research as it aims to understand the lived experience of pessary using women, 
therefore it is essential that the steering committee members with this lived experience are in 
agreement with the coding and themes developed by the researcher. 
 
The public members of the steering group will be asked to contribute to the writing up and dissemination 
of study findings. Public members will be asked to review manuscript drafts to ensure they are in 
agreement with the interpretation of study findings. Findings will be submitted for presentation at both a 
national and international conference. Funding has been requested for a public member of the project 

 
 
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steering group to attend the national conference and co-present study findings. Study findings will also 
be disseminated with assistance of the RCOG Women’s Network Co-ordinator via Facebook support 
groups for women with prolapse as well as being shared via the RCOG twitter account and inclusion in an 
RCOG e-newsletter to The Women's Voices Involvement Panel (over 500 members throughout UK). 
 
14. DISSEMINATION POLICY 
• Data arising from the study will be owned by Manchester University NHS Foundation Trust.  
• On completion of each research phase, the data will be analysed and published in scientific 
journals. Following completion of the research, the findings will be submitted for presentation 
at a national and international conference.   
• Study participants can opt to receive a summary of the research findings following completion 
of the study on the consent form. 
 
Authorship eligibility guidelines and any intended use of professional writers 
In accordance with guidelines created by The International Committee of Medical Journal Editors, all 
authors will meet the following criteria and will have: 
• made substantial contributions to the conception or design of the work; or the acquisition, 
analysis, or interpretation of data for the work; 
• performed drafting of the work or revised it critically for important intellectual content; 
• approved the final version of the article prior to publication;  
• agreed to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
 
15. EQUALITY AND DIVERSITY STATEMENT  
All individuals will be considered for inclusion in this study regardless of age, disability, gender 
reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and 
sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise. 
 

 
 
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