Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study
Phase: NA
Conditions: Urinary Incontinence
Sponsor: University of Nottingham

 
 
 
POsITIve 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
PHYSIOTHERAPY MANAGEMENT OF URINARY INCONTINENCE IN 
ATHLETIC WOMEN- A FEASIBILITY STUDY 
 
Version: V 1.0 
 
28th March 2019 
 
 
 
 
 
Short title: Physiotherapy to treat Urinary Incontinence in Athletes 
 
 
Acronym:   
POsITIve 
 
 
 
 
 
 
Funding Source: 
University of Nottingham and the Medical 
Research Council 
 
 

 
 
 
POsITIve 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
STUDY PERSONNEL AND CONTACT DETAILS 
 
 
Chief Investigator:  
Dr Gillian Campbell 
Daphne Jackson Research Fellow  
Faculty of Medicine & Health Sciences, 
University of Nottingham, 
B Floor, Medical School, 
Queen’s Medical Centre, 
Nottingham, NG7 2UH. 
Phone: 0115 823 0116 
Email: gillian.campbell@nottingham.ac.uk 
 
 
 
 
 
 
Co-investigators:  
Professor Avril Drummond 
Professor of Healthcare Research / 
Director of Research 
Faculty of Medicine & Health Sciences, 
University of Nottingham, 
B Floor, Medical School, 
Queen’s Medical Centre, 
Nottingham, NG7 2UH. 
Phone: 0115 823 0493 
Email: avril.drummond@nottingham.ac.uk 
 
Professor Mark Batt 
Consultant in Sports and Exercise Medicine 
Nottingham University Hospitals NHS Trust, 
West Block C Floor, 
Queen’s Medical Centre, 
Nottingham, NG7 2UH. 
Phone: 0115 919 4400 
Email: mark.batt@nottingham.ac.uk 
 
Mr Martin Powell 
Consultant Gynaecologist 
Nottingham University Hospitals NHS Trust, 
Queen’s Medical Centre, 
Nottingham, NG7 2UH. 
Phone: 0115 970 5800 
Email: martincpowell@doctors.org.uk 
 
 
 

 
 
 
POsITIve 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
 
SYNOPSIS 
Title 
Physiotherapy Management Of Urinary InconTinence In Athletic 
Women – a feasibility study 
 
Acronym 
POsITIve                 
Short title 
Physiotherapy to treat Urinary Incontinence in Athletes 
Chief Investigator 
Dr Gillian Campbell (Daphne Jackson Research Fellow, University 
of Nottingham) 
Objectives 
To assess the feasibility of conducting a randomised controlled 
trial of physiotherapeutic intervention in the management of urinary 
incontinence in athletic women  
Study Configuration 
Single centre 
Setting 
Local community 
Number of 
participants 
Phase 1: 6-8 local health professionals 
Phase 2: 15-20 athletic women recruited from local sports clubs 
and gyms 
Phase 3: 6-8 of the participants from phase 2 
 
Eligibility criteria 
Phase 1: 
 G.P.s, Nurses, Physiotherapists from the Nottinghamshire 
and Derbyshire area 
Phase 2: 
 Female 
 18 years and over 
 Currently exercising three times and for over 150 minutes 
per week 
 Self-reported symptoms of urinary incontinence including 
urinary frequency and increased urinary urge 
 No ongoing or recent intervention for treatment of UI  
Phase 3:    
 Purposeful selection of a range of participants from phase 2 
Description of 
interventions 
Phase 1:  
 Local healthcare professionals will be interviewed to 
establish general management of UI in athletic women 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Phase 2: 
 All participants will complete a sporting log, questionnaires 
ICIQ, UDI 6 and a fluid chart 
 Participants will undergo a subjective and objective 
physiotherapy assessment 
 A pelvic floor muscle rehabilitation plan will be agreed and 
participants will attend for physiotherapy, education and 
advice for up to 7 interventions over 6 months 
 At 3 months and 6 months participants will repeat 
questionnaires ICIQ, UDI 6 and a further fluid chart 
 Participants will be discharged from treatment or, if still 
symptomatic, referred, if they wish, for ongoing care 
Phase 3: 
 Participants will be purposefully selected from phase 2 for 
qualitative interviews in order to obtain information about 
their reactions to phase 2 and in depth data regarding how 
their symptoms have impacted on their life and any 
previous attempts to address their symptoms 
Duration of study 
Overall:     01/05/19 – 31/09/20   
Per participant: 
Phase 1  participants – up to 30 minutes  
 
Phase 2  participants – up to 6 months  
 
Phase 3 participants – up to 30 minutes  
Methods of analysis  
Qualitative data will be analysed thematically 
 
Quantitative data will be analysed using descriptive statistics 
 
 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
ABBREVIATIONS 
 
UI 
 
Urinary Incontinence 
 
AE 
 
Adverse Event 
 
 
CI 
 
Chief Investigator overall 
 
 
CRF 
 
Case Report Form 
 
 
PFM 
 
Pelvic Floor Muscles 
 
 
DMC  
Data Monitoring Committee 
 
 
GCP 
 
Good Clinical Practice 
 
 
HRA 
 
Health Research Authority 
 
 
ICF 
 
Informed Consent Form 
 
 
NHS 
 
National Health Service 
 
 
PI 
 
Principal Investigator at a local centre 
 
PIS 
 
Participant Information Sheet 
 
 
REC 
 
Research Ethics Committee 
 
R&D 
 
Research and Development department 
 
 
SAE 
 
Serious Adverse Event 
 
UoN                 University of Nottingham 
 
MRC  
Medical Research Council 
 
HCP 
 
Health Care Professional 
 
CSP 
 
Chartered Society of Physiotherapy 
 
HCPC  
Health and Care Professions Council 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
TABLE OF CONTENTS 
STUDY PERSONNEL AND CONTACT DETAILS..................................................... 2 
SYNOPSIS ............................................................................................................ 3 
ABBREVIATIONS ................................................................................................. 5 
TABLE OF CONTENTS ............................................................................................ 6 
STUDY BACKGROUND INFORMATION AND RATIONALE .................................... 8 
STUDY OBJECTIVES AND PURPOSE .................................................................. 10 
PURPOSE ........................................................................................................... 10 
PRIMARY OBJECTIVES ........................................................................................ 10 
STUDY DESIGN ..................................................................................................... 10 
STUDY MANAGEMENT ......................................................................................... 11 
DURATION OF THE STUDY AND PARTICIPANT INVOLVEMENT ....................... 11 
End of the Study ..................................................................................................... 12 
SELECTION AND WITHDRAWAL OF PARTICIPANTS ......................................... 12 
Recruitment ......................................................................................................... 12 
Phase 1 ........................................................................................................... 12 
Phase 2 ........................................................................................................... 12 
Phase 3 ........................................................................................................... 12 
Eligibility criteria ...................................................................................................... 13 
Inclusion criteria .................................................................................................. 13 
Phase 1: .......................................................................................................... 13 
Phase 3 ........................................................................................................... 13 
Exclusion criteria ................................................................................................. 13 
Phase 1 ........................................................................................................... 13 
Phase 2 and 3:................................................................................................. 13 
Expected duration of participant participation ...................................................... 14 
Participant Withdrawal ......................................................................................... 14 
Informed consent................................................................................................. 14 
STUDY REGIMEN .................................................................................................. 15 
Phase 1 ........................................................................................................... 15 
Phase 2 ........................................................................................................... 15 
Phase 3 ........................................................................................................... 18 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
ANALYSES ............................................................................................................. 18 
Methods .............................................................................................................. 18 
Sample size and justification ............................................................................... 18 
Phase 1 ........................................................................................................... 18 
Phase 2 ........................................................................................................... 18 
Phase 3 ........................................................................................................... 19 
ADVERSE EVENTS ............................................................................................... 19 
ETHICAL AND REGULATORY ASPECTS ............................................................. 19 
ETHICS COMMITTEE AND REGULATORY APPROVALS .................................... 19 
INFORMED CONSENT AND PARTICIPANT INFORMATION ................................ 20 
RECORDS .............................................................................................................. 20 
Study Forms ........................................................................................................ 20 
Source documents .............................................................................................. 21 
Direct access to source data / documents ........................................................... 21 
DATA PROTECTION .............................................................................................. 21 
QUALITY ASSURANCE & AUDIT .......................................................................... 22 
INSURANCE AND INDEMNITY .......................................................................... 22 
STUDY CONDUCT ............................................................................................. 22 
STUDY DATA ..................................................................................................... 22 
RECORD RETENTION AND ARCHIVING .......................................................... 22 
STATEMENT OF CONFIDENTIALITY ................................................................ 23 
PUBLICATION AND DISSEMINATION POLICY ................................................. 23 
USER AND PUBLIC INVOLVEMENT .................................................................. 23 
STUDY FINANCES ................................................................................................. 23 
FUNDING SOURCE ............................................................................................ 23 
PARTICIPANT STIPENDS AND PAYMENTS ..................................................... 23 
SIGNATURE PAGES .............................................................................................. 24 
REFERENCES ....................................................................................................... 25 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
STUDY BACKGROUND INFORMATION AND RATIONALE 
 
Urinary incontinence (UI) is defined as including symptoms of involuntary loss of 
urine associated with change of position, impact or urgency and to include increased 
urinary urgency and increased daytime frequency (Haylen et al., 2010). This is a 
widespread problem in adult women, with prevalence being reported in the UK as 
high as 40% (Cooper et al., 2015). It is both embarrassing and debilitating for those 
affected, impacting on all aspects of life. There is evidence that it reduces 
participation in sports and exercise (Brown and Miller, 2001, Nygaard et al., 2005, 
Menezes, 2015), affects employment, causes absence from the workplace (Fultz et 
al., 2005) and is detrimental to personal relationships (Nilsson et al., 2009). 
Generally it is accepted that UI is associated with childbirth, obesity and the ageing 
process (Danforth et al., 2006, Kuh et al., 1999). As such it is assumed that a 
primary cause is weakness of the pelvic floor muscles (PFM).  
UI is particularly common in athletic and sporting women and has been reported as 
being almost double that in a matched group of sedentary counterparts (Carvalhais 
et al., 2018). Investigations into UI in athletes reveals varying prevalence ranging 
from 23 – 41% (Alves et al., 2017, Bo et al., 2011, Carls, 2007, Jacome et al., 2011). 
Generally these studies involved young, nulliparous athletes. An investigation into 
recreationally active women revealed much higher numbers of 49%, although this 
figure was only related to stress urinary incontinence (SUI) and did not allow for 
urgency or urge related incontinence (UUI) (McKenzie et al., 2016). This was an 
investigation of athletes with a large range of ages, 18 – 83, and parity which may 
explain the high prevalence compared with other studies of younger nulliparous 
women with fewer risk factors. Improving the strength and endurance of PFM is 
generally regarded the optimal first line in treatment. While there is evidence to 
support physiotherapy to treat UI in the general population (Bo et al., 1999, Dumoulin 
et al., 2004) and it is supported by NICE (NICE, 2013), there is little research 
regarding interventions in athletes, despite the high levels of UI in this population.  
It has been suggested that there are two conflicting mechanisms for UI in athletic 
women:  
 Athletes may have stronger pelvic floors than non-athletes due to the training 
effect of repeated impact  
 
the repeated challenge of ground reaction forces from running and jumping 
may serve to weaken and stretch the fascia and muscle tissues within the 
pelvis (Bo, 2004).  
One possible explanation, which might allow for athletes having stronger pelvic floors 
but still presenting with UI, would be if the pelvic floor muscle was strong and stiff but 
inextensible i.e. unable to fully relax. An overactive PFM group would potentially be 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
unable to react to ground reaction forces adequately. Increased PFM tension has 
been noted in cases of increased urinary urge and frequency with or without 
associated pelvic pain (Weiss, 2001). Assessment of some PFM can reveal areas 
within the tissue that are overactive or ‘tight’ (Aw et al., 2017).  There is little 
published data regarding how prevalent this is or whether this is more likely in certain 
groups of women. It is, however, feasible that the athletic PFM may be dysfunctional 
rather than weak. In this case it would be imperative that there is an assessment by 
a specialist physiotherapist in order to identify the appropriate training and 
rehabilitation programme. Standard protocols advising general PFM strengthening 
with no tailored advice may not afford any real improvement and in some cases may, 
in fact, aggravate the symptoms. 
There are few studies evaluating conservative management strategies in an athletic 
population (Da Roza et al., 2012, Ferreira et al., 2014) and while these have shown 
improvements, only the latter used a control group. It was also unclear from the 
methodology in this RCT, whether the rehabilitation was guided by any formal PFM 
assessment such as a digital vaginal assessment (DVE) or other forms of 
biofeedback. Despite the high prevalence of UI generally in women, less than half of 
these will present to health professionals for help (Cooper et al., 2015). This is an 
even bigger issue in athletes with UI where 90% of those with UI reported not 
mentioning their symptoms to anyone (Carls, 2007). It is important to rationalise why 
these women do not seek help and when they do ensure that they are offered 
effective, evidence based treatment. 
This study is a first step to investigating what treatments are offered in the 
community to athletic women presenting with UI and to the acceptability and benefits 
of one to one specialist physiotherapy treatment within this patient group. 
 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
STUDY OBJECTIVES AND PURPOSE 
PURPOSE 
 
Our overall purpose is to conduct an RCT to determine whether one to one 
physiotherapy can improve the symptoms of urinary incontinence (UI) in a group of 
athletic women. This feasibility study will enable us to ascertain the viability of 
conducting a definitive appropriately powered trial. 
PRIMARY OBJECTIVES 
 
The primary objective is to assess the feasibility of conducting a randomised 
controlled trial of physiotherapeutic intervention in the management of urinary 
incontinence (UI) in female athletes and those that exercise regularly.  
This will involve gathering and analysing information regarding the eligibility criteria 
of the participants and data regarding recruitment. It will provide information about 
the consent procedures, outcome measures, the acceptability of the intervention, 
retention of participants and use the data to inform the determination of a sample 
size calculation for a definitive trial. 
STUDY DESIGN 
 
This is a mixed-methods study with three distinct but related phases.  
In phase 1, six to eight local health care professionals (HCP) including general 
practitioners, nurses and physiotherapists, will be recruited for interview. This will 
explore current management practices of UI in the community to inform a future 
control group and to review current knowledge regarding specialist pelvic health 
physiotherapy. 
In phase 2, participants who are sporting or athletic women, who self- report 
symptoms of UI, will be recruited from the local sporting community.  
Urinary incontinence will be defined as any of the following:  
 stress urinary incontinence (SUI), leaking of urine associated with increased 
abdominal pressure e.g. impact, coughing or sneezing 
 urge urinary incontinence (UUI) leaking of urine associated with urinary urge, 
increased urinary urge and/or increased urinary frequency  
Sporting or athletic women will be defined as those who exercise three or more times 
a week and for more than 150 minutes each week. 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Each participant will undergo individual subjective and objective assessments in 
order to establish history, symptoms and pelvic floor muscle function. The 
intervention will be then be tailored from these assessments, where upon 
participants will be enrolled into the intervention agreed between each individual and 
the specialist physiotherapist. This is likely to include guided exercise within the clinic 
and a regular home exercise plan and will be in keeping with typical rehabilitation 
regimes for PFM dysfunction within this specialist area. If appropriate, soft tissue 
release techniques may be used to reduce muscle spasm. 
In phase 3, six to eight participants that take part in phase 2 will be offered the 
opportunity to take part in a qualitative interview in order to gain more in-depth 
understanding. The aim of the interviews will be to explore the acceptability of the 
intervention and the effects of UI on quality of life and participation in sport and 
exercise. We will purposefully select participants in order to account for age, sporting 
activity and severity of symptoms. 
STUDY MANAGEMENT 
 
The Chief Investigator has overall responsibility for the study and shall oversee all 
study management. 
The data custodian will be the Chief Investigator. 
A study steering group, comprising the co-investigators, two service user 
representatives and a specialist pelvic health physiotherapist, will oversee the study. 
DURATION OF THE STUDY AND PARTICIPANT INVOLVEMENT 
 
Study Duration:  
Enrolment will begin in May 2019 and cease in March 2020.  
The total duration of the study will be 18 months (excluding one month for write up 
and dissemination)  
Participant Duration:  
Phase 1: 
Approximately 30 minutes  
Phase 2: 
Up to six months 
Phase 3: 
Approximately 30 minutes  

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
 
End of the Study 
 
The final data collection will be 31st September 2020. The end of the study including 
analysis and dissemination will be 31st January 2021. 
SELECTION AND WITHDRAWAL OF PARTICIPANTS 
 
Recruitment 
Phase 1 
We will aim to recruit six to eight local health care professionals for interview to 
explore their knowledge of UI in athletic women and how they might manage these 
patients. They will be approached by email, through professional and personal 
contacts or via professional networks, e.g. Royal College of General Practitioners, 
Royal College of Nurses, and Chartered Society of Physiotherapy.  
Phase 2 
Participants will be athletic and sporting adult women who self-report urinary 
incontinence. 
Urinary incontinence will be defined as any of the following: leaking of urine 
associated with increased abdominal pressure e.g. impact, leaking of urine 
associated with urinary urge, increased urinary urge and/or increased urinary 
frequency.  
Athletic and sporting women will be defined as those who exercise over three times 
a week and for more than 150 minutes in total each week.  
We aim to recruit 15 – 20 adult women from the Derbyshire and Nottinghamshire 
community via: 
 Pelvic health presentations to local sports clubs and gyms 
 Emails to local sports clubs and gyms 
 Leaflets to local sports clubs and gyms 
 
Social media e.g. Facebook, Twitter 
Phase 3 
Six to eight of the participants from phase 2 will be purposefully recruited to be 
interviewed about their experience of phase 2 of this study, their experiences of UI 
and the effects on their quality of life and sporting participation and any previous 
experience they have had of treatment for UI. The selection will be purposeful in 
order to account for a range of ages, type and severity of UI and of primary sporting 
activity.  

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Eligibility criteria 
 
Inclusion criteria 
Phase 1: 
 Qualified local Health Care Professional eg G.P., nurse or chartered 
physiotherapist working within Nottinghamshire or Derbyshire.  
Phase 2:    
 Adult female 
 Currently exercising for a minimum 3 times a week and for over 150 minutes 
per week 
 Self-reported experience of symptoms of UI defined as; leaking of urine 
associated with increased abdominal pressure e.g. impact, leaking of urine 
associated with urinary urge, increased urinary urge and/or increased urinary 
frequency. 
Phase 3:   
 Participant in Phase 2, purposeful selection will be made to ensure a range of 
age, sporting activity and UI symptoms. 
Exclusion criteria 
Phase 1 
 Unwilling or unable to provide written informed consent 
 Not within Nottinghamshire or Derbyshire area 
 Unable to read or speak English 
Phase 2 and 3 
 Under 18  
 Sports participation less than 1 year 
 Pregnancy  
 Less than one year after childbirth 
 Ongoing physiotherapy or continence advice treatment elsewhere or within 
the last year 
 De novo oestrogen or anticholinergic treatment 
 Existing neurological conditions that may contribute to UI eg multiple 
sclerosis, stroke, spinal injury etc 
 Unwilling or unable to provide written informed consent 
 Unable to read or speak English 
 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Expected duration of participant participation 
Phase 1 participants 
Up to 30 minutes  
Phase 2 participants 
01/05/19 – 31/09/20 (there will be up to 1 year of 
recruitment until 15 – 20 participants are enrolled: each 
intervention will be up to 6 months, so the last participant 
may be 31/03/20 – 31/09/20) 
Phase 3 participants 
Up to 30 minutes  
Participant Withdrawal  
 
In each of the study phases, participants may withdraw from the study either at their 
own request or be withdrawn at the discretion of the Investigator. Participants will be 
made aware (via the participant information sheet and consent form) that should they 
withdraw, the data collected cannot be erased and may still be used in the final 
analysis. 
Participants who withdraw will be replaced if this is possible within the time frame of 
the study. The last participant will be recruited by 31/02/20. 
Informed consent 
 
All participants in Phases 1, 2 and 3 will provide written informed consent. The 
Consent Form will be signed and dated by the participant before they enter the 
study. The Investigator will explain the details of the study and provide a Participant 
Information Sheet (PIS), ensuring that the participant has a minimum period of 24 
hours to consider participating or not. The Investigator will answer any questions that 
the participant has concerning study participation.  
In phase 2 there will be a separate written informed consent obtained for digital 
vaginal examination as is good practice in this physiotherapy speciality. At this stage 
the participant will be offered the opportunity for a chaperone to be present for the 
DVE. If they would like this but are unable to provide one then one will be provided 
by the research group. It will be noted in writing whether they have chosen to have a 
chaperone or not. 
For all consent forms completed, one copy of the consent form will be kept by the 
participant and one will be kept by the Investigator. 
Should there be any subsequent amendment to the final protocol, which might affect 
a participant’s participation in the study, continuing consent will be obtained using an 
amended consent form which will be signed by the participant. 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
STUDY REGIMEN 
 
Phase 1 
Participants will be recruited to take part in semi-structured interviews. These 
interviews will establish the type of advice and treatment routinely prescribed for this 
patient group. It will also explore the participant’s previous knowledge of specialist 
pelvic health physiotherapy. 
The interviews will be conducted face to face by a member of the research team and 
arranged at the convenience of the participant. The interviews will take place at a 
location convenient to the participant. Digital audio-recordings will be transferred to a 
secure and password protected file on a dedicated web server at the University of 
Nottingham. Personal identifiers will be removed. The recording will then be deleted 
from the recording device. Anonymised recordings will be sent electronically to a 
transcribing service approved by the University of Nottingham.  
Phase 2 
Following an expression of interest in the study, a participant information sheet will 
be sent, either via email or by post, and potential participants will be given 24 hours 
to read this prior to any appointments. 
The researcher will then contact the potential participant, explain the study and 
answer any questions that the potential participant may have. If they are happy to 
proceed the researcher will arrange an appointment at a location to suit the 
participant. This will be either within the hospital site or at a clinic in the community. 
At the first appointment the process of completing the study questionnaires, sporting 
log and fluid charts will be explained in greater detail. Written, informed consent will 
be taken prior to any data collection.  
Questionnaires will include urinary symptoms eg the type and severity of their UI and 
the degree this impacts on their quality of life and their sporting participation. 
The sporting log will record information regarding the time, intensity, type of sporting 
activity and any related incontinence episodes. 
The fluid chart will be a three day record of all measured fluid input and output with 
any incontinence episodes noted. Two labelled jugs will be provided. 
Questionnaires, sporting log and fluid chart will be collected at the second 
appointment with a specialist pelvic health physiotherapist. This will include a full 
subjective assessment recording their obstetric, gynaecological and past medical 
history. 
An objective assessment is planned to include a digital vaginal examination (DVE) of 
pelvic floor function. Further written consent will be obtained in line with best practice 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
in this field. If the participant is unwilling to have a DVE, they will be asked if they 
wish to continue with the questionnaires at 3 and 6 months. Those that agree to this 
will be issued with an advice leaflet and reviewed at 3 and 6 months but will have no 
other formal rehabilitation plan. Those that are unwilling to continue with data 
collection will be excluded from the study. 
Participants will be asked if they wish a chaperone to be present for the DVE if they 
wish this to be the case but are unable to provide one, then one will be provided by 
the research study. The choice to have a chaperone or not will be noted in their file. 
After the assessment DVE of the PFM, participants will be offered the opportunity for 
electromyographic (EMG) assessment of their PFM to establish the level of activity 
at rest and if function is altered in an upright position. 
A tailored training plan will be agreed between the participant and the pelvic health 
physiotherapist depending on the results of the subjective and objective 
assessments. It is likely that this will include a home exercise plan, re-education of 
their pelvic floor contractions with EMG biofeedback in the clinic and lifestyle advice. 
If appropriate, soft tissue techniques may be used to reduce marked muscle spasm. 
Objective assessments including the DVE, questionnaires and fluid charts will be 
repeated at 3 months and at 6 months.  

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
 
 
Figure 1 Flow chart of participants through Phase 2 
 

 
 
 
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POsITIve Study: Protocol Version: V 1.0, Date: 28/03/2019 
This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Compliance 
Compliance will be assessed throughout phase 2. If the participant does not engage 
with the training and feedback then the investigator will re-address whether the 
participant still consents to completing the study. 
Phase 3 
Six to eight of the participants in phase 2 will be purposefully selected for a semi-
structured interview for up to 30 minutes. This will discuss their experience of phase 
2 of the study and any previous treatments they may have had for UI. It will explore 
their experiences of UI and the effects on their quality of life and sporting 
participation.  
The interviews will be conducted face to face by a member of the research team 
Digital audio-recordings will be transferred to a secure and password protected file 
on a dedicated web server at the University of Nottingham. Personal identifiers will 
be removed. The recording will then be deleted from the recording device. 
Anonymised recordings will be sent electronically to a transcribing service approved 
by the University of Nottingham. 
Criteria for terminating the study 
The study is unlikely to be terminated.  Research data will not be destroyed but 
archived according to the archiving procedure detailed later. 
ANALYSES 
 
Methods  
The data will be analysed by members of the research team.  
Qualitative data will be analysed thematically. Nvivo software will be used to manage 
qualitative data. 
Quantitative data will be analysed using descriptive statistics.  
Analysis will take place on University of Nottingham computers and backed up on 
the University of Nottingham servers.  
Sample size and justification 
Phase 1 
The sample size has been determined by the research team and relevant literature 
(Malterud et al., 2016) and is appropriate for this study. 
Phase 2  
As this is a feasibility study, the purpose is to provide estimates of recruitment and 
retention rates alongside the acceptability of the intervention therefore a formal 

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
sample size calculation is not required. Traditionally sample sizes between 24 and 
50 are recommended for a feasibility study(Sim and Lewis, 2012), but consideration 
of the intensity and length of the proposed intervention also needs to be considered 
in deciding the sample size. This sample size will enable us to determine the 
feasibility of conducting a definitive trial. 
Phase 3 
The sample size has been determined by the research team and relevant literature 
as being of a sufficient size (Malterud et al., 2016). 
ADVERSE EVENTS 
 
The occurrence of an adverse event as a result of participation within this study is 
not expected in phases 1 or 3. Any adverse event data will be collected and 
reported. 
It is again unlikely that any adverse events are likely to arise as part of the 
intervention in phase 2, as the intervention is standard physiotherapy practice for this 
issue, but any observation of unexpected pathology or trauma eg cancer, female 
genital mutilation or history of abuse during the subjective or objective parts of the 
assessment process will be discussed with the research team gynaecologist and 
appropriate advice taken.  
ETHICAL AND REGULATORY ASPECTS 
 
No significant ethical, legal or management issues are anticipated. 
University research ethics committee approvals will be required and sought for the 
participants in Phase 1, 2 and 3. 
ETHICS COMMITTEE AND REGULATORY APPROVALS 
 
The study will not be initiated before the protocol, consent forms and participant 
information sheets have received approval / favourable opinion from the University of 
Nottingham, Faculty of Medicine and Health Sciences, Research Ethics Committee 
(REC). 
Should a protocol amendment be made that requires ethical approval, the changes 
in the protocol will not be instituted until the amendment and revised informed 
consent forms and participant information sheets (if appropriate) have been reviewed 
and received approval / favourable opinion from the University REC. Minor protocol 
amendments only for logistical or administrative changes may be implemented 
immediately; and the REC will be informed. 

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
The study will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice 
and the UK Department of Health Policy Framework for Health and Social Care, 
2017. 
INFORMED CONSENT AND PARTICIPANT INFORMATION 
 
The process for obtaining participant informed consent will be in accordance with the 
REC guidance, and Good Clinical Practice (GCP) and any other regulatory 
requirements that might be introduced. The investigator or their nominee and the 
participant shall both sign and date the Consent Form before the person can 
participate in the study. 
The participant will receive a copy of the signed and dated forms and the original will 
be retained in the Study records.  
The decision regarding participation in the study is entirely voluntary. The 
investigator or their nominee shall emphasize to them that consent regarding study 
participation may be withdrawn at any time without penalty. No study-specific 
interventions will be done before informed consent has been obtained. 
The investigator will inform the participant of any relevant information that becomes 
available during the course of the study, and will discuss with them, whether they 
wish to continue with the study. If applicable they will be asked to sign revised 
consent forms. 
If the Consent Form is amended during the study, the investigator shall follow all 
applicable regulatory requirements pertaining to approval of the amended Consent 
Form by the REC and use of the amended form (including for ongoing participants). 
RECORDS  
Study Forms  
 
Each participant will be assigned a study identity code number, for use on study 
forms, other study documents and the electronic database. The documents and 
database will also use their initials (of first and last names separated by a hyphen or 
a middle name initial when available). 
Study forms will be treated as confidential documents and held securely in 
accordance with regulations 
Study forms shall be restricted to those personnel approved by the Chief Investigator 
and recorded as such in the study records.  

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Medical records will be stored securely and in accordance with good clinical practice 
for a time period of eight years from the last intervention. This is the recommended 
time for record retention by the Chartered Society of Physiotherapy who will be 
providing professional liability. 
A letter documenting the outcomes of the assessments and intervention for each 
participant in phase 2 will be sent to the patients GP, with the participant’s 
agreement, for recording within their medical records. 
All paper forms shall be filled in using black ballpoint pen. Errors shall be lined out 
but not obliterated by using correction fluid and the correction inserted, initialled and 
dated. 
The Chief or local Investigator shall sign a declaration ensuring accuracy of data 
recorded in the study form. 
Source documents  
 
Source documents shall be filed at the investigator’s site and may include but are not 
limited to, consent forms, study records, field notes, interview transcriptions and 
audio records. Intervention notes from Phase 2 will be filed during the intervention at 
the site that the participant has chosen from the two sites offered. A study form may 
also completely serve as its own source data. Only study staff shall have access to 
study documentation other than the regulatory requirements listed below. 
Direct access to source data / documents 
The study form and all source documents shall made be available at all times for 
review by the Chief Investigator, Sponsor’s designee and inspection by relevant 
regulatory authorities.  
DATA PROTECTION  
 
All study staff and investigators will endeavour to protect the rights of the study’s 
participants to privacy and informed consent, and will adhere to the Data Protection 
Act, 2018. The study form will only collect the minimum required information for the 
purposes of the study. Study forms will be held securely, in a locked room, or locked 
cupboard or cabinet. Access to the information will be limited to the study staff and 
investigators and any relevant regulatory authorities (see above). Computer held 
data including the study database will be held securely and password protected. All 
data will be stored on a secure dedicated web server. Access will be restricted by 
user identifiers and passwords (encrypted using a one way encryption method). 
Information about the study in the participant’s medical records / hospital notes will 
be treated confidentially in the same way as all other confidential medical 
information. 

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
Electronic data will be backed up every 24 hours to both local and remote media in 
encrypted format. 
QUALITY ASSURANCE & AUDIT  
INSURANCE AND INDEMNITY 
Insurance and indemnity for clinical study participants and study staff is covered 
within the professional indemnity provided by the CSP as the proposed interventions 
are covered within the researcher’s scope of practice. There are no special 
compensation arrangements, but study participants may have recourse through the 
CSP. 
STUDY CONDUCT 
 
Study conduct may be subject to systems audit for inclusion of essential documents; 
permissions to conduct the study; CVs of study staff and training received; local 
document control procedures; consent procedures and recruitment logs; adherence 
to procedures defined in the protocol (e.g. inclusion / exclusion criteria,  timeliness of 
visits); accountability of study materials and equipment calibration logs. 
STUDY DATA  
 
Monitoring of study data shall include confirmation of informed consent; source data 
verification; data storage and data transfer procedures; local quality control checks 
and procedures, back-up and disaster recovery of any local databases and validation 
of data manipulation. The Study Coordinator/Academic Supervisor shall carry out 
monitoring of study data as an ongoing activity.  
Entries on study forms will be verified by inspection against the source data. A 
sample of study forms (10% or as per the study risk assessment) will be checked on 
a regular basis for verification of all entries made. In addition the subsequent capture 
of the data on the study database will be checked. Where corrections are required 
these will carry a full audit trail and justification. 
Study data and evidence of monitoring and systems audits will be made available for 
inspection by the REC as required. 
RECORD RETENTION AND ARCHIVING 
In compliance with the ICH/GCP guidelines, regulations and in accordance with the 
University of Nottingham Code of Research Conduct and Research Ethics, the Chief 
Investigator will maintain all records and documents regarding the conduct of the 
study. These will be retained for at least 7 years or for longer if required. If the 
responsible investigator is no longer able to maintain the study records, a second 
person will be nominated to take over this responsibility.  

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
The study documents held by the Chief Investigator shall be finally archived at 
secure archive facilities at the University of Nottingham.  This archive shall include all 
anonymised audio recordings, study databases and associated meta-data encryption 
codes. 
STATEMENT OF CONFIDENTIALITY 
  
Individual participant personal information obtained as a result of this study are 
considered confidential and disclosure to third parties is prohibited with the 
exceptions noted above. 
Participant confidentiality will be further ensured by utilising identification code 
numbers to correspond to treatment data in the computer files. 
Such medical information may be given to the participant’s medical team and all 
appropriate medical personnel responsible for the participant’s welfare.  
If information is disclosed during the study that could pose a risk of harm to the 
participant or others, the researcher will discuss this with the CI and where 
appropriate report accordingly. 
Data generated as a result of this study will be available for inspection on request by 
University of Nottingham representatives. 
 
PUBLICATION AND DISSEMINATION POLICY 
 
The study results will be submitted to academic journals and conferences. 
Participants will not be identified in any publications. 
USER AND PUBLIC INVOLVEMENT 
Membership of the study steering group will include two service user 
representatives. 
STUDY FINANCES 
FUNDING SOURCE 
This study is funded by the University of Nottingham and the Medical Research 
Council. 
PARTICIPANT STIPENDS AND PAYMENTS 
Participants will not be paid to participate in the study. Travel expenses will not be 
reimbursed routinely but we may be able to support some participants with particular 
difficulties. 

 
 
 
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This protocol is confidential and the property of the University of Nottingham. No part of it may be 
transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
SIGNATURE PAGES 
 
Signatories to Protocol: 
 
Chief Investigator: (name) Dr Gillian Campbell 
________________________________ 
 
Signature:__ 
________________________________ 
 
 
Date: 28th March 2019___________ 
 
 
 
 
Co-investigator: (name) Professor Avril Drummond 
_______________________________ 
 
 
Signature:___ 
_______________________________ 
 

 
 
 
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transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
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transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Nottingham 
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