Safety and Efficacy of Low-elasticity Polyvinylidene Fluoride (DynaMesh®-SIS Soft) Retropubic Tension Free Midurethral Sling in the Treatment of Stress Urinary Incontinence in Women
Conditions: Urinary Stress Incontinence, Urinary Incontinence,Stress
Sponsor: Julie Dawson

 
 
 
 
 
Safety and efficacy of low elasticity polyvinylidene 
fluoride (DynaMesh®-SIS soft) retropubic tension free 
midurethral sling in the treatment of stress urinary 
incontinence in women. 
Research Protocol 
4 April 2016 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
2 
 
 
TABLE OF CONTENTS 
SIGNATURES 
4 
RESEARCH TEAM 
65 
GENERAL INFORMATION 
76 
SUMMARY 
1110 
BACKGROUND 
1211 
HYPOTHESIS 
1413 
AIM 
1413 
PRIMARY OUTCOME 
1413 
SECONDARY OUTCOMES 
1413 
RESEARCH DESIGN AND METHODS 
1514 
Study design 
1514 
Study centers 
1514 
Responsible surgeons 
1514 
Current practice 
1514 
Language 
1514 
Study Plan 
1615 
Study Population 
1920 
Eligibility 
1920 
Recruitment 
1920 
Withdrawal of consent 
1920 
Study Procedures 
2021 
Pre-enrollment investigation 
2021 
Consent visit 
2021 
Operative procedure 
2021 
Clinical follow up visits 
2122 
Questionnaire follow up 
2122 
Data Collection 
2223 
Patient Questionnaire Data 
2223 
Preoperative data 
2223 
Operative data 
2325 
Clinical follow up data – 3 month and 12 month 
2325 
Investigational Medical Device 
2426 
Safety 
2527 
Adverse Events 
2527 
Definition of Serious Adverse Events 
2527 
Reporting of Serious Adverse Events 
2527 
Follow up of Adverse Events 
2527 
ANALYTICAL METHODS 
2729 
Number of study participants 
2729 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
3 
 
 
Data Analysis 
2729 
Efficacy 
2729 
Safety 
2830 
Quality of life: 
2830 
Interim analysis 
2830 
Data Handling 
2931 
Source Data 
2931 
Unique study numbers 
2931 
Data Protection 
3032 
STUDY ADMINISTRATION 
3133 
Funding 
3133 
Ethical Issues 
3133 
Risks and burdens to participants 
3133 
Potential benefits to participants 
3133 
DISSEMINATION OF RESULTS 
3234 
Safety data and Serious Adverse Events 
3234 
Publication of results 
3234 
REFERENCES 
3335 
APPENDICES 
3537 
Permission to Contact – Version 1.1 (Attached as separate document) 
 
Participant Information Sheet - Version 1.5 (Attached as separate document)  
Participant Consent Form - Version 1.2 (Attached as separate document) 
 
Letter to GP - Version 1.2 (Attached as separate document) 
 
Data Collection Form - Version 1.2 (Attached as separate document) 
 
ICIQ-FLUTS questionnaire (Attached as separate document) 
ICIQ-LUTSqol questionnaire (Attached as separate document) 
 
 
 
 
 
 
 
 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
4 
 
 
 
SIGNATURES 
 
Chief Investigator  
 
……………………………………………………         Date    ……………………… 
Sambit Mukhopadhyay, Norfolk and Norwich University Hospitals NHS Trust, 
Norwich, UK 
 
 
 
        
Principal Investigators 
 
……………………………………………………         Date    ……………………… 
Sambit Mukhopadhyay, Norfolk and Norwich University Hospitals NHS Trust, 
Norwich, UK 
 
……………………………………………………         Date    ……………………… 
Mark Slack, Cambridge University Hospitals NHS Trust, Cambridge, UK 
 
……………………………………………………         Date    ……………………… 
Arvind Vashisht,  University College Hospital,  London, UK 
 
……………………………………………………         Date    ……………………… 
Helen Johnson, Hinchingbrooke Health Care NHS Trust, Huntingdon, UK 
 
……………………………………………………         Date    ……………………… 
Mr Mark Doyle, Wirral University Teaching Hospital NHS Foundation Trust, 
Upton, UK 
 
……………………………………………………         Date    ……………………… 
Gurminder Matharu, Heart of England NHS Foundation Trust, Solihull, UK 
 
……………………………………………………         Date    ……………………… 
Inna Sokolova, University Hospital Crosshouse, Kilmarnock, UK 
  
……………………………………………………         Date    ……………………… 
David Glenn,  South Eastern Health and Social Care Trust, Belfast, UK 
 
……………………………………………………         Date   ………………………     
 
Laura Mc Morran, Northern Health and Social Care Trust, Antrim, UK 
 
……………………………………………………         Date    ……………………… 
Ursula Peschers, Chirurgische Klinik, Munich, Germany 
 
……………………………………………………         Date    ……………………… 
Ralf Joukhadar, Frauenklinik, Würzburg, Germany 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
5 
 
 
 
Sponsor Contact 
 
……………………………………………………          Date    ……………………... 
Lisa Chalkley, Norfolk and Norwich University Hospitals NHS Trust, Norwich, 
UK 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
6 
 
 
RESEARCH TEAM 
 
Chief Investigator  
Sambit Mukhopadhyay, Consultant Gynaecologist  
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 
 
Investigators 
Charlotte Cassis, Research Fellow 
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 
 
Edward Morris, Consultant Gynaecologist 
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 
 
Catherine Appleby, Senior Clinical Fellow  
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 
 
Mark Slack, Consultant Urogynaecologist  
Addenbrooke’s Hospital 
Cambridge University Hospitals NHS Trust, Cambridge, UK 
 
Ian Nunney, Medical Statistician  
Norwich Medical School, University of East Anglia, Norwich, UK 
 
SPONSOR 
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 
 
Sponsor Contact 
Lisa Chalkley, Research Services Manager 
Norfolk and Norwich University Hospitals NHS Trust, Norwich, UK 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
7 
 
 
GENERAL INFORMATION 
Title: 
 
Safety and efficacy of low elasticity polyvinylidene 
fluoride (DynaMesh®-SIS soft) retropubic tension 
free midurethral sling in the treatment of stress 
urinary incontinence in women. 
 
Short Title: 
 
How well does the low stretch tension free tape 
(DynaMesh®-SIS 
soft) 
treat 
stress 
urinary 
incontinence in women. 
 
Study Design: 
 
Prospective multicentre international observational 
cohort study. 
 
Chief Investigator: 
 
Mr Sambit Mukhopadhyay 
 
Norfolk and Norwich University Hospital 
Norfolk and Norwich University Hospitals NHS 
Foundation Trust 
Colney Lane 
Norwich 
United Kingdom 
NR4 7UY 
SAMBIT.MUKHOPADHYAY@nnuh.nhs.uk 
 
 
0044(0)1603 287100 
 
 
Principal Investigators: 
UNITED KINGDOM 
 
 
 
Charlotte Cassis, Research Fellow 
 
 
 
Norfolk and Norwich University Hospitals Trust 
 
 
 
Mr Mark Slack 
Addenbrooke’s Hospital 
Cambridge University Hospitals NHS Foundation 
Trust 
Cambridge Biomedical Campus 
Hills Road 
Cambridge 
United Kingdom 
CB2 0QQ 
mark.slack@addenbrookes.nhs.uk 
 
 
Mr Arvind Vashisht 
Urogynaecologist 
University College Hospital 
235 Euston Road  
London 
United Kingdom 
NW1 2BU 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
8 
 
 
Arvind.Vashisht@uclh.nhs.uk 
 
 
Dr Helen Johnson 
Consultant Obstetrician and Gynaecologist 
Hinchingbrooke Health Care NHS Trust 
Hinchingbrooke Hospital 
Hinchingbrooke Park 
Huntingdon 
Cambridgeshire 
United Kingdom 
PE29 6NT  
hjohnson2@nhs.net 
 
Mr P Mark Doyle 
Consultant Obstetrician & Gynaecologist 
Wirral University Teaching Hospital NHS Foundation 
Trust 
Arrowe Park hospital  
Arrowe Park Road 
Upton  
Wirral 
Merseyside 
United Kingdom 
CH49 5PE 
pdoyle1@nhs.net 
 
Mr Gurminder Matharu MB ChB, FRCOG 
Consultant Gynaecologist 
Heart of England NHS Foundation Trust 
Solihull Hospital 
Lode Lane  
Solihull 
West Midlands 
United Kingdom 
B91 1PS 
gurminder.matharu@heartofengland.nhs.uk 
 
 
Dr Inna Sokolova 
Consultant Gynaecologist 
NHS Ayrshire & Arran 
Ayrshire Maternity Unit 
University Hospital Crosshouse  
Kilmarnock 
United Kingdom 
KA2 0BE 
Inna.Sokolova@aapct.scot.nhs.uk 
 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
9 
 
 
 
Dr David Glenn 
 
Consultant Obstetrician and Gynaecologist 
 
Ulster Hospital 
 
South Eastern Health and Social Care Trust 
Upper Newtownards Road 
Dundonald 
Belfast 
United Kingdom 
BT16 1RH 
david.glenn@setrust.hscni.net 
 
  
Dr Laura McMorran  
Consultant Obstetrician and Gynaecologist 
Antrim Area Hospital 
Northern Health and Social Care Trust 
Bush Road 
Antrim 
United Kingdom 
BT41 2RL 
Laura.mcmorran@northerntrust.hscni.net 
 
 
 
 
GERMANY 
 
Professor Ursula Peschers 
Consultant Urogynaecologist 
Chirurgische Klinik  
München-Bogenhausen  
Denninger Str. 44  
81679  
Munich 
Germany 
peschers@chkmb.de 
 
Dr Ralf Joukhadar 
Universitätsklinikum Würzburg  
Frauenklinik 
Josef-Schneider-Straße 4 
97080  
Würzburg 
Germany 
joukhadar_r@ukw.de 
 
 
 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
10 
 
 
 
 
R&D Reference: 
2015O&G01M 
 
Clinical Trials Reference: NCT02407145 
 
Ethics Committee: 
NRES Committee East of England - Cambridge 
South  
The Old Chapel  
Royal Standard Place  
Nottingham  
NG1 6FS 
United Kingdom 
 
REC reference: 
15/EE/0204 
 
Sponsor: 
Norfolk and Norwich University Hospitals NHS Trust 
Colney Lane 
 
Norwich 
 
NR4 7UY 
 
United Kingdom 
 
Sponsor Contact: 
Lisa Chalkley 
 
Research Services Manager 
 
Norfolk and Norwich University Hospital Trust 
 
lisa.chalkley@nnuh.nhs.uk 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
11 
 
 
SUMMARY 
 
This study is designed to evaluate the safety and efficacy of low elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS 
soft) 
retropubic 
tension-free 
midurethral slings in the treatment of stress urinary incontinence (SUI) in 
women.   The efficacy and safety will be reported over two years of follow up. 
 
Stress urinary incontinence is a common problem, affecting large numbers of 
women.  If conservative measures are ineffective then surgery is offered.  
Surgery involves a permanent mesh sling being placed, tension free beneath 
the midurethra.  The standard retropubic tension-free vaginal tape (TVT) is 
made of polypropylene.  The use of permanent mesh in gynaecology has 
come under scrutiny in recent years due to significant complications for 
women.  
 
The sling being studied is DynaMesh®SIS soft, made of polyvinylidene 
fluoride (PVDF) which has improved biocompatibility with tissues compared to 
polypropylene.  The technique of retropubic placement of the DynaMesh®SIS 
soft does not differ from current retropubic TVT placement. 
 
The results of the efficacy and safety of DynaMesh®SIS soft will be compared 
with the safety and efficacy of traditional polypropylene slings, as reported in 
current literature.  It is hypothesised that this sling is non-inferior compared to 
traditional polypropylene slings in both parameters. 
 
There are eleven research centres in two countries, The United Kingdom and 
Germany.  The DynaMesh®SIS soft sling is currently in use in four of the 
research hospitals, Norwich (main research centre), Belfast and Antrim in the 
UK and in Munich in Germany.  It will be introduced in London, Cambridge, 
Upton, Solihull, Huntingdon and Kilmarnock in the UK and Würzburg in 
Germany.. 
 
Women with SUI who are suitable for a retropubic tape and have never had 
an incontinence operation will be included.  They will have urodynamics prior 
to demonstrate SUI.  Participants would complete standardised urinary 
incontinence and quality of life questionnaires prior to their procedure and at 
3,6,12, 18 and 24 months by post.  Clinical follow up will occur at 3 and 12 
months post operatively and as required if any concerns. 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
12 
 
 
BACKGROUND 
 
Retropubic midurethral slings are a well-established surgical procedure for 
treatment of stress urinary incontinence in women.  The TVT (Tension Free 
Tape) procedure was introduced by Ulmsten in 19961 and has become a 
standard surgical procedure for stress urinary incontinence.  Polypropylene is 
the traditional mesh used for the procedure.  The objective success rate of the 
retropubic TVT procedure is reported as 80% at 12 months2, with other 
longer-term results reported as 85% at 5 years3 and 90% at 17 years4. 
 
Recognised complications of the retropubic TVT procedure5 include 
postoperative voiding difficulties, new urinary urgency or frequency, bladder 
injury (0.7% to 24%), bowel injury (<1%), haemorrhage (0.7% to 8%) with 
2.8% requiring transfusion and wound infection rate of <1%.  The rate of 
vaginal erosion ranges from 0% to 1.6% and urethral injury or erosion 0.3%.  
 
The safety of mesh implants in gynaecology has been questioned in recent 
years with a warning issued by the FDA6 in 2011.  The Medicines and 
Healthcare Products Regulatory Agency (MHRA) in the UK released its 
conclusions regarding mesh use in gynaecology in October this year.  After 
review of available information the MHRA has stated that the benefits of 
vaginal mesh implants outweigh the risks and there is no remove these 
devices from practice in the UK.  Regarding safety there was no evidence that 
one device differed from another.  Ongoing review of information about mesh 
use will continue and would consider post-market clinical follow-up as 
important in terms of monitoring usage and safety.7 
 
The suitability of mesh for implantation depends on the following qualities of 
the mesh – biocompatibility, stability, effective porosity and elasticity.    The 
surgical expertise and patient selection are also generally recognized as 
factors in safe use of vaginal mesh. 
 
The following ideal properties have been proposed for pubovaginal slings – 
large pore size (>1mm) mesh with minimal elasticity, width of 10mm with no 
change in width under tension, blunt edges and made of a permanent material 
with limited tissue reaction – with little resulting fibrosis and shrinkage8.   
 
Polyvinylidene fluoride (PVDF) monofilament thread has high stability over 
time, its surface does not degrade and the thread does not become brittle or 
lose significant tensile strength over time, both in vitro and in vivo in animal 
experiments9,10.  PVDF is used as a suture material in cardiovascular surgery.    
The material was investigated as an alternative material for mesh implants for 
abdominal hernia repair in 2002 in an animal model11.  As an implant material 
PVDF continued to have high biocompatibility with reduced fibrosis and scar 
formation 
compared 
with 
convention 
implant 
materials 
made 
of 
polypropylene12.    PVDF mesh has been shown to be a suitable material for 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
13 
 
 
the use in abdominal hernia surgery with high success rates and low rates of 
infection and bowel adhesion13,14. 
 
PVDF slings have been in use since 2006, marketed as DynaMesh®-SIS.  
The design of the sling was modified in 2011 by reducing the diameter of the 
individual PVDF threads to create DynaMesh®-SIS soft.   DynaMesh®-SIS soft 
is warp knitted from polyvinylidene fluoride (PVDF) thread and measures 1cm 
wide and 50cm long.  It is specifically designed for its use as a midurethral 
sling for the treatment of female stress urinary incontinence.  The mesh is 
macroporous and has low elasticity meaning it maintains its dimensions, and 
as a result pore size, when under tension.  This also means that the load of 
the sling on the urethra is dissipated over a larger surface area.  Compared to 
conventional polypropylene mesh DynaMesh®-SIS has a reduced reactive 
surface area with high effective porosity15.  As each sling is individually knitted 
it has soft edges and does not require plastic sheath for smooth movement 
through tissues8.   
 
The above properties of DynaMesh®-SIS soft make it an attractive alternative 
to traditional polypropylene slings.  The surgical procedure for inserting the 
DynaMesh®-SIS soft retropubically does not differ from current retropubic TVT 
placement, therefore the same procedural risks exist.  Given its physical 
properties the exposure and erosion rate of DynaMesh®SIS soft sling are not 
thought to be greater than that of traditional polypropylene slings. 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
14 
 
 
HYPOTHESIS 
 
PVDF (DynaMesh®SIS soft) sling is non-inferior to traditional retropubic 
midurethral slings in the treatment of stress urinary continence, when 
compared to the reported safety and efficacy of retropubic polypropylene 
midurethral slings in current literature. 
 
AIM 
 
To investigate the safety and efficacy of the low-elasticity polyvinylidene 
fluoride (DynaMesh®-SIS soft) retropubic midurethral sling in the treatment of 
stress urinary incontinence in women. 
 
PRIMARY OUTCOME  
 
 
The subjective cure rate of retropubic midurethral PVDF slings in 
treating stress urinary incontinence. 
 
 
The rate of complications of retropubic midurethral PVDF slings, in 
particular mesh erosions. 
 
SECONDARY OUTCOMES  
 
 
Changes in quality of life, with regards to urinary symptoms, following 
placement of a retropubic midurethral PVDF sling. 
 
 
The subjective cure rate of retropubic midurethral PVDF slings in 
treating stress urinary incontinence compared to the reported cure rate 
for traditional polypropylene retropubic slings. 
 
 
The rate of complications of retropubic midurethral PVDF slings, in 
particular vaginal erosions and how the rates of complications compare 
to those reported in the literature for traditional polypropylene 
retropubic slings. 
 
 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
15 
 
 
RESEARCH DESIGN AND METHODS 
Study design 
A prospective multicentre international observational cohort study. 
Study centers  
Eleven centers in two European countries – nine in the United Kingdom – 
Norwich, Cambridge, Huntingdon, London, Upton, Solihull,  Kilmarnock, 
Belfast and Antrim and two in Germany – Munich and Würzburg. 
.   
Responsible surgeons  
Thirteen responsible surgeons are involved at the eleven study centres, they 
include three urogynaecologist and ten gynaecologists with a special interest 
in urogynaecology.   
Current practice  
DynaMesh®-SIS and DynaMesh®-SIS soft are used routinely used in two of 
the research centres – Antrim (6 years), Belfast (5 years), Munich (2 years) 
and Norwich (1.5 years). 
Language 
All documents will be translated in to German for the centres in Germany, 
coordinated by the centres in Germany.  There are German versions of the 
study questionnaires already available. 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
16 
 
 
Study Plan 
 
Recruitment 
Attends routine outpatient visit – stress incontinence identified 
 Routine management commenced 
 Deemed appropriate for Multichannel Urodynamics  
- 
results prove urodynamic stress incontinence 
 
Follow up outpatient visit - identified as being suitable for a midurethral sling 
 Check inclusion/exclusion criteria 
 Introduce the concept of the study 
 Give Consent for Contact letter and inform local researcher 
 If immediately interested in study give Participant Information Sheet 
and inform local researcher 
 
 
1) 
Consent visit 
 Surgical consent taken by surgeon or their team 
 Obtain written consent for surgical procedure – three copies – patient, 
medical notes and participant file 
 Obtain consent for BSUG database (UK participants) 
 Research consent obtained by local researcher or assistant 
 Obtain written consent for study – three copies – patient, medical notes 
and participant file 
 Assign study number – record in data collection form 
 Complete baseline data 
 Record urodynamic results   
 Ask to complete preoperative questionnaires and calculate scores by 
adding item scores 
o ICIQ-FLUTS 
o ICIQ-LUTSqol 
o Record individual answers for ICIQ-FLUTS questions 9a, 11a, 
12a 
 Send participation letter to GP 
 If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
2) 
Day of surgery 
 Attend research centre for procedure 
 Document surgical parameters  
 Document surgical complications and outcomes 
 Document success of trial of voids 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
17 
 
 
 
3) 
Clinical Review – three months post operatively 
 Document if dry from stress urinary incontinence 
 Document if experience urinary urgency 
 Document if experiencing any difficulties in voiding 
 Document if experiencing pain at site of tape 
 Document if experiencing vaginal discharge 
o Perform vaginal examination 
o Document mesh erosion – presence, size and site 
o If present inform responsible surgeon or their medical staff for 
management plan 
 Ask to complete study questionnaires and calculate scores by adding 
item scores 
o ICIQ-FLUTS 
o ICIQ-LUTSqol 
o Record individual answers for ICIQ-FLUTS questions 9a, 11a, 
12a 
 Forward operative and three month follow up data to Research Fellow 
at Norwich Research Centre 
 If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
4) 
Six months post operatively 
 Send out study questionnaires with reply paid envelopes 
o ICIQ-FLUTS 
o ICIQ-LUTSqol 
 Contact participant if not received back after 4 weeks 
 Calculate scores by adding item scores 
 Record individual answers for ICIQ-FLUTS questions 9a, 11a, 12a 
 Collate responses in participant file 
 If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
5) 
Clinical Review – twelve months post operatively 
 Document if dry from stress urinary incontinence 
 Document if experience urinary urgency 
 Document if experiencing any difficulties in voiding 
 Document if experiencing pain at site of tape 
 Document if experiencing vaginal discharge 
 Document if sexually active, if yes if any problems  
o Perform vaginal examination 
o Document mesh erosion - presence, size and site 
o If present inform responsible surgeon or their medical staff for 
management plan 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
18 
 
 
 Ask to complete study questionnaires and calculate scores by adding 
item scores 
o ICIQ-FLUTS 
o ICIQ-LUTSqol 
o Record individual answers for ICIQ-FLUTS questions 9a, 11a, 
12a 
 Forward six month and twelve month data to Research Fellow at 
Norwich Research Centre 
 If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
6) 
Eighteen months post operatively 
 Send out study questionnaires with reply paid envelopes 
o ICIQ-FLUTS 
o ICIQ-LUTSqol  
 Contact participant if not received back after 4 weeks 
 Calculate scores by adding item scores 
 Record individual answers for ICIQ-FLUTS questions 9a, 11a, 12a 
 Collate responses in participant file 
 If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
7) 
Twenty-four months post operatively 
 
Send out study questionnaires with reply paid envelopes 
o 
ICIQ-FLUTS 
o 
ICIQ-LUTSqol 
 
Contact participant if not received back after 4 weeks 
 
Calculate scores by adding item scores 
 
Record individual answers for ICIQ-FLUTS questions 9a, 11a, 12a 
 
Collate responses in participant file 
 
Forward eighteen month and twenty-four month data to Research 
Fellow at Norwich Research Centre 
 
If depression is identified on ICIQ-LUTSqol (Question 12) inform 
participant GP for further follow up 
 
 
Study completion 
 Send 
letter 
thanking 
participants 
for 
their 
involvement 
and 
communicating results 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
19 
 
 
Study Population 
Eligibility 
Eligible participants will be identified from routine referrals to the outpatient 
gynaecology and urology clinics of the responsible surgeons.  Those women 
who present with symptomatic stress urinary incontinence and subsequently 
have proven urodynamic stress incontinence may be eligible for enrollment in 
the study. 
 
Participant inclusion criteria  
 
Women with proven urodynamic stress incontinence deemed suitable 
for retropubic midurethral sling procedure as per the treating surgeon.   
 
Only women having sling placement as their primary incontinence 
procedure without any concomitant prolapse procedure will be 
included.   
 
Participant exclusion criteria  
 
Urodynamic studies negative or inconclusive for stress urinary 
incontinence.   
 
Previous incontinence surgery or planned concomitant prolapse 
surgery.   
 
Not speaking English or German, depending on study centre. 
 
Lacking the capacity to consent. 
Recruitment 
Following urodynamic studies and confirmation that a midurethral sling is 
appropriate, as the next step in management of their stress urinary 
incontinence, they will be offered a midurethral sling.  If they meet the 
eligibility criteria a member of the site research team with explain the study, 
give them time to ask questions and give them the Participant Information 
Leaflet.  The potential participants will be informed that participation in the 
study in voluntary.  Potential participants will have at least 24 hours to 
consider their participation in the study.  They will have until their surgical 
consent visit to consider their participation, in clinic practice this may be 
several weeks. 
Withdrawal of consent 
Participants may withdraw from the study at any time.  Any data already 
collected with still be used, however no further questionnaires will be sent and 
no 12 month follow up will occur.  If participants withdraw consent on the day 
of surgery they may still have their procedure but no study data will be 
collected.  If consent is withdrawn prior to their three month follow up they will 
require follow up but no study data will be collected. 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
20 
 
 
Study Procedures 
 
Pre-enrollment investigation 
Multichannel 
conventional 
urodynamics 
proving 
urodynamic 
stress 
incontinence must be performed to confirm eligibility for inclusion in the study 
Consent visit  
A consent visit will occur prior to the day of surgery.  At this visit consent will 
be obtained for both the surgical procedure and participation in the study.   
 
Surgical consent will be obtained by the surgeon or their team.  For 
participants in the UK they will also be asked to consent to collection of 
operative data on the British Society of Urogynaecologists (BSUG) database.  
Surgeons who are members of BSUG are encouraged to enter their surgical 
cases on the BSUG database for ongoing personal, local and national audit of 
surgical procedures, their outcomes and complications for all urogynaecology 
procedures. 
 
Research consent will be obtained by a member of the site research team.  
They will again explain the study to the participant and ensure their study 
related questions are answered.  The participants will be informed that their 
participation is voluntary and that they may withdraw their consent at any time 
without any impact on their care. 
 
Participants will be asked to complete the ICIQ_FLUTS and ICIQ-LUTSqol 
questionnaires prior to their surgery.  If depression is identified on the ICIQ-
LUTSqol questionnaire (question 12) the researcher will contact the 
participant’s primary care doctor for follow up. 
 
 
Operative procedure 
 
The surgery will be performed by either the responsible surgeon, a 
competent surgeon at the site as agreed by the responsible surgeon or 
a supervised trainee. 
 
All procedures to be included in the study will be performed via the 
retropubic approach, either “bottom-up” or “top-down”, with check 
cystoscopy after sling placement.   
 
Tensioning of the sling to be performed using the Hager 8/4 technique 
– Hager size 8 cervical dilator placed in urethra and size 4 between the 
sling and urethra for standardisation of tensioning and maintaining the 
same distance between urethra and the tape. 
 
The choice of anaesthesia and dissection technique (hydrodissection 
etc.) will be left to individual surgeon. 
 
Operative antibiotic prophylaxis as per local protocols. 
 
Post-operative trial of voids as per local protocols. 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
21 
 
 
 
Clinical follow up visits 
 
Clinical follow up will be undertaken at 3 months and 12 months by the 
surgeon, their medical staff, specialist nurse or research nurse.   
 
This will include subjective evaluation of patient symptoms – dryness 
from stress urinary incontinence, pain, urgency, normal voiding and 
whether they are sexually active, and if so if there are any concerns. 
 
A vaginal examination will be performed to document the presence of 
mesh erosion and its size and location if present.  Management of the 
erosion will be planned as per the local surgical team and recorded. 
 
Further investigation or treatment of residual urinary symptoms will also 
be documented. 
 
The two validated questionnaires will be repeated.  
 
If depression is identified on the ICIQ-LUTSqol questionnaire (question 
12) the researcher will contact the participant’s primary care doctor for 
follow up. 
 
Travel costs for the twelve month follow up visit will be reimbursed by 
arrangements made by each research centre.    
 
Questionnaire follow up 
 
The two study questionnaires will be posted to study participants at 
intervals 6, 18 and 24 months post operatively. 
 
If they have not been returned within 4 weeks the participants will be 
contacted by their research centre.   
 
Reply paid envelopes for return of the questionnaires will be arranged 
by each research centre. 
 
If depression is identified on the ICIQ-LUTSqol questionnaire (question 
12) the researcher will contact the participant’s primary care doctor for 
follow up. 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
22 
 
 
Data Collection 
Patient Questionnaire Data 
All questionnaires are available in both English and German. 
Completed preoperatively, 3, 6, 12, 18 and 24 months postoperatively. 
 
Validated incontinence questionnaires – International Consultation on 
Incontinence Modular Questionnaire (ICIQ) 
 
ICIQ-FLUTS 
o 13 questions including date of birth 
o Takes 5 minutes to complete 
o Three scores obtained: 
 F score – scored 0-15 by adding item scores 2a-5a to 
assess bladder filling symptoms 
 V score – scored 0-12 by adding item scores 6a-8a to 
assess voiding function 
 I score – scored 0-20 by adding item scores 9a-13a to 
assess incontinence 
 Individual questions assess presence of: 
 Urge incontinence (9a) 
 Stress incontinence (11a) 
 Other incontinence (12a) 
 
Validated urinary quality of life questionnaire 
 
ICIQ-LUTSqol  
o 22 questions including date of birth and gender 
o Takes 10 to 15 minutes to complete 
o Scored 19-76 (by adding item scores) with increased score 
indicating more significant impact on quality of life 
Preoperative data  
 
Demographics 
o age  
o BMI 
 
Obstetric and gynaecology history  
o Parity 
o pelvic floor exercises 
o previous prolapse surgery  
 
Multichannel conventional urodynamics  
o presence of urodynamic stress incontinence (inclusion criteria) 
o uroflowmetry – Qmax (mL/sec) 
o residual volume 
o presence of detrusor overactivity 
o pressure flow study PdetQmax (cmH20) 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
23 
 
 
Operative data 
 
Intraoperative POP-Q findings  
 
Method of anaesthesia  
o retropubic infiltration 
o general anaesthesia, sedation 
 
Surgical approach  
o “bottom-up” 
o “top-down” 
 
Intraoperative complications  
o bladder injury 
o urethral injury 
o bowel injury 
o estimated blood loss 
o retropubic hematoma 
o vaginal hematoma 
o return to theatre 
o significant pain (admission required) 
 
Postoperative voiding 
o successful trial of void 
o discharge home with catheter 
o postoperative day of successful trial without catheter 
Clinical follow up data – 3 month and 12 month  
 
Presence of 
o Stress urinary incontinence 
 
o urinary urgency 
 
 
 
o difficulties in voiding  
o pain at site of tape  
 
o vaginal discharge 
o sexual activity and presence of problems 
 
 
Presence of mesh erosion 
o site – central or in lateral sulci 
o size of erosion 
o management plan 
 
Study questionnaire scores 
o ICIQ-FLUTS  
 
 
 
o ICIQ-LUTSqol 
 
 
 
 
 
Ongoing management 
o Topical estrogen  
 
 
o Surgery  
 
 
 
 
o Suturing 
 
 
 
o Excision exposed mesh 
 
 
o Removal of sling 
 
 
 
o Anticholinergic 
 
 
 
o Urodynamic Studies  

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
24 
 
 
Investigational Medical Device 
 
DynaMesh®-SIS soft  
 
Physical properties 
DynaMesh®-SIS soft is warp knitted from polyvinylidene fluoride (PVDF) 
thread and measures 1cm wide and 50cm long. 
 
Intended purpose 
Midurethral sling for surgical treatment of stress or mixed urinary 
incontinence. 
 
Manufacturer  
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH 
Prager Ring 70 
Aachen 
52070 
GERMANY 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
25 
 
 
Safety 
Adverse Events 
The procedure for placement of a retropubic midurethral sling is well 
established.  There are recognised complications.  Those complications 
related to the procedure are: 
 
bladder perforation 
 
haemorrhage and retropubic hematoma 
 
difficulty with bladder emptying 
 
infection – wound and urinary 
 
pain 
 
mesh erosion into the vagina and urethra 
 
bowel injury (rare). 
 
The procedure for introducing DynaMesh®-SIS soft slings retropubically does 
not differ from the established procedure for inserting traditional retropubic 
polypropylene slings, therefore the complications are not expected to differ. 
 
For adverse events that are not considered serious they should be recorded 
in the participant file as part of the research data in monitoring the safety of 
the PVDF sling.  The Principal Investigator will report to the Sponsor if 
adverse events are occurring at a greater than expected frequency. 
Definition of Serious Adverse Events 
The definition of a Serious Adverse Event (SAE) is any adverse occurrence 
that:  
 results in death  
 is life-threatening  
 requires hospitalisation, or prolongation of existing inpatients’ 
hospitalisation.  
 results in persistent or significant disability or incapacity  
 is otherwise considered medically significant by the investigator  
 is a congenital anomaly or birth defect  
Reporting of Serious Adverse Events  
If a complication is deemed to be a SAE the Principal Investigator they will 
report to the Chief Investigator and Sponsor as soon as possible after 
becoming aware of the SAE and within 24 hours for further assessment by the 
Sponsor as per NNUH SOP 206 for adverse events.  This will be done by way 
of completion of a SAE form sent directly to the Chief Investigator and 
Sponsor. 
Follow up of Adverse Events 
Each research centre has procedures in place for management of 
complications.   Complications occurring for individual participants will be 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
26 
 
 
managed as per local procedures, recorded in participants medical and 
research file and notified to the main research centre as part of data reporting.  
 
If a participant attends hospital for emergency review thought to be related to 
their retropubic sling the research team will be informed and documentation of 
the event added to the participant file.   
 
Complications are reported routinely by way of the BSUG database in the UK. 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
27 
 
 
ANALYTICAL METHODS 
Number of study participants  
Comparing a success rate of 85% for DynaMesh®-SIS soft versus 80% cure 
at one year for the polypropylene retropubic tapes, as reported in literature, 
with a non-inferiority margin of 2% a power of 80% and type I error rate of 5%, 
a sample size of 197 is required to detect a difference greater than the non-
inferiority margin, given such a difference does exist.   
 
Allowing for a 10% drop of rate a total sample size of 218 will be recruited.   
 
Data Analysis 
Efficacy  
The rate of cure at 3,6,12,18 and 24 months with 95% confidence intervals 
will be reported.   
 
Cure will be defined as: 
 
The rate of reported “dryness” from stress urinary incontinence at three 
and 12 months with 95% confidence intervals. 
 
Scoring of the ICIQ-FLUTS question 11a score – a score of 0 to 1 
representing no or minimal symptoms representing cure.  The rate of 
cure reported as percentage with 95% confidence intervals. 
 
Subgroup analysis  
 
Evaluation of efficacy with exclusion of the "top-down" cases. 
 
Improvement in incontinence symptoms 
 
Change in questionnaire scores for urinary incontinence (ICIQ-FLUTS I 
score)  
 
To calculate whether or not there has been a significant improvement 
between pre and post-operative questionnaire scores a Wilcoxon sign 
rank test will be applied to each questionnaire at each study point 
(3,6,12,18,24 months). 
 
Efficacy in comparison with polypropylene slings: 
The PVDF sling can be assumed to be as effective as traditional 
polypropylene  midurethral retropubic slings if the confidence interval includes 
78%, with a non-inferiority margin of 2% compared with reported efficacy of 
80% at 12 months for polypropylene  midurethral retropubic slings. 
 
Occurrence of de novo urinary symptoms 
 
Urgency/filling symptoms – ICIQ-FLUTS F score 
 
Voiding symptoms – ICIQ-FLUTS V score 
 
Urge incontinence – ICIQ-FLUTS question 9a 
 
Other incontinence – ICIQ-FLUTS question 12 a 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
28 
 
 
 
To calculate whether or not there has been a significant increase (ie 
worsening of symptoms) between pre and post-operative questionnaire 
scores a Wilcoxon sign rank test will be applied to each of the above 
questionnaire scores at each study point (3,6,12,18,24 months). 
 
Safety  
 
The rates of complications will be presented as percentages with 95% 
confidence intervals and reported in relation to complication rates 
reported in current literature related to the traditional TVT. 
 
Complications reported will be intraoperative complications – bladder 
injury, urethral injury, bowel injury, estimated blood loss 
 
Postoperative complications – retropubic hematoma, return to theatre, 
voiding difficulties 
 
Quality of life: 
 
Change in quality of life scores -ICIQ-LUTSqol 
 
To calculate whether or not there has been a significant improvement 
between pre and post-operative questionnaire scores a Wilcoxon sign 
rank test will be applied to each questionnaire at each study point 
(3,6,12,18,24 months). 
Interim analysis 
 
Interim analysis will be performed after 12 months to assess for safety 
of the procedure  
 
This will evaluate the rates of recognised complications occurring 
perioperatively and at the three month follow up. 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
29 
 
 
Data Handling 
Source Data 
All participants will be assigned a unique study number based on their 
research centre and recruitment number.  Personal data (name, address, date 
of birth and hospital number) for each participant will be kept locally only and 
not shared outside the local research team.   
 
Research data will be collected locally via data collection sheets and be 
identified by unique study number only.  These will be scanned and emailed 
to the named Research Fellow at Norfolk and Norwich University Hospital for 
entry into the research database at three intervals – after the 3 month follow 
up, after the 12 month follow up and at 24 months.   The Research Fellow will 
confirm receipt of each data collection sheet and collate on the central study 
database. 
 
Data from Germany will be collated electronically by a study representative 
and sent to the Research Fellow at the main research centre at 3 months, 12 
months and 24 months. 
 
Unique study numbers 
These will be allocated at the time of the consent visit.  The numbers will 
reflect the country, research centre and participant number at the site 
reflecting sequential recruitment. 
 
Codes 
Country 
Centre 
United Kingdom 
UK 
Norwich 
Cambridge  
London 
Huntingdon 
Upton 
Solihull 
Kilmarnock 
Belfast 
Antrim 
01 
02 
03 
04 
05 
06 
07 
08 
09 
 
 
 
 
 
 
Germany 
DE 
Munich 
Würzburg 
10 
11 
 
Hence the first participant recruited to Munich, Germany will have the unique 
study number DE-10-01 
 
Individual centres will be responsible for ensuring continuity of unique study 
number throughout the study. 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
30 
 
 
Data Protection 
Personal data will be required for sending out study questionnaires and for 
arranging follow up appointments, this database will be stored on password 
protected NHS computers within the United Kingdom. 
 
Research data will be transferred electronically as an email attachment from 
study centers to the principal study center, participants will be identifiable by 
unique study number only. 
 
Data collected during the course of the research will be kept strictly 
confidential and accessed only by members of the trial team.  Participant’s 
details will be stored on a secure database under the guidelines of the 1998 
Data Protection Act and regular checks and monitoring are in place to ensure 
compliance.  Data are stored securely in accordance with the Act and 
archived to a secure data storage facility.  The senior IT manager (in 
collaboration with the Chief Investigator) will manage access rights to the data 
set.  
 
Participants’ details will be anonymised on the secure database. To comply 
with the 5th Principle of the Data Protection Act 1998, personal data will not 
be kept for longer than is required for the purpose for which it has been 
acquired. 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
31 
 
 
STUDY ADMINISTRATION 
 
Funding 
Kebomed UK, Distributor of medical devices and surgical implants. 
Unit 7 Kingsford Rural Business Centre 
Kentisbeare  
Cullompton 
Devon 
UNITED KINGDOM 
EX15 2AU 
 
Ethical Issues 
Approval to be sought by the research committees.  
United Kingdom: NRES Committee East of England - Cambridge South  
Germany 
No recruitment will occur until ethics approval has been granted. 
Risks and burdens to participants 
 
Procedural 
o There are no physical risks to participants associated with the 
insertion of a retropubic DynaMesh®-SIS soft above those 
associated with insertion of the traditional polypropylene 
retropubic midurethral sling.  The surgical procedure will not be 
altered from normal clinical practice. 
o The risk to participants of mesh exposure or erosion is unknown.  
The researchers believe that because of the physical properties 
of PVDF and DynaMesh®-SIS soft, as previously outlined, the 
risk is not likely to be greater than that associated with traditional 
slings   
 
Time 
o Time to complete questionnaires – this has been considered 
and the number of questionnaires minimised   
 
Financial 
o Financial costs to participants will be limited by supplying reply 
paid envelopes for return of research questionnaires and 
reimbursement of travel costs for the 12 month follow up, which 
is additional to routine postoperative care.  Arrangements for 
postage costs and reimbursements will be organised by 
individual research centres. 
 
Potential benefits to participants 
 
Ongoing postoperative support. 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
32 
 
 
DISSEMINATION OF RESULTS 
Safety data and Serious Adverse Events 
Safety concerns or new information regarding the PVDF sling (DynaMesh®-
SIS soft) will be communicated to the Sponsor by the Principle Investigator . 
 
Participants will be notified by letter of new information regarding the product. 
Publication of results 
Results of this study will be published as research articles at follow up 
intervals of 6, 12, 18 and 24 months.  The results will also be submitted for 
presentation at medical conferences.  

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
33 
 
 
REFERENCES 
 
1. 
Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical 
procedure under local anaesthesia for treatment of female urinary 
incontinence.  Int Urogynecol J Pelvic Floor Dysfunct 7(2):81-85 
 
2. 
Richter HE, Albo ME, Zyczynski HM, et al. Urinary Incontinence 
Treatment Network.  Retropubic versus transobturator midurethral 
slings for stress incontinence. N Eng J Med. 2010;362(22):2066. 
 
3. 
Nilsson CG, Kuuva N, Falconer C, et al. Long-term results of the 
tension-free vaginal tape (TVT) procedure for surgical treatment of 
female stress urinary incontinence. Int Urogynecol J. 2001; 12(2): 
Supplement, pp S5-S8 
 
4. 
Nilsson CG, Palva K, Aarnio R, et al. Seventeen years’ follow-up of the 
tension-free vaginal tape procedure for female stress incontinence. Int 
Urogynecol J. 2013; 24(8):1265-1269 
 
5. 
Daneshgari F, Kong W, Swartz M. Complications of mid urethral slings: 
Important outcomes for future clinical trials.  J Urology 2008; 180: 
1890-1897 
 
6. 
U.S. FDA Safety Communication: urogynecologic surgical mesh: 
update on the safety and effectiveness of transvaginal placement for 
pelvic organ prolapse. July 2011 
 
7. 
A summary of the evidence on the benefits and risks of vaginal mesh 
implants. October 2014.  Medicines and Healthcare Products 
Regulatory Agency, United Kingdom. 
 
8. 
Klinge U, Binneboesel M, Kuschel S, et al. Demands and properties of 
alloplastic implants for the treatment of stress urinary incontinence. 
Expert Rev. Med. Devices 2007; 4(3): 349-359 
 
9. 
Urban E, King MW, Guidoin R, et al. Why make monofilament sutures 
out of polyvinylidene fluoride? ASAIO J 1994; 40(2): 145-56 
 
10. 
Laroche G, Marois Y, Schwarz E, et al. Polyvinylidene fluoride 
monofilament sutures: can they be used safely for long-term 
anastomoses in the thoracic aorta? Artif Organs 1995; 19(11): 1190-9 
 
11. 
Klinge U, Klosterhalfen B, Ottinger AP et al.  PVDF as a new polymer 
for the construction of surgical meshes.  Biomaterials 2002; 23: 3487-
3493 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
34 
 
 
12. 
Gerullis H, Klosterhalfen B, Boros M, et al. IDEAL in meshes for 
prolapse, urinary incontinence, and hernia repair. Surg Innov 2013; 
20(5): 502-508 
 
13. 
Berger D, Bientzle M. Polyvinylidene fluoride: A suitable mesh material 
for laparoscopic incisional and parastomal hernia repair! Hernia 2008; 
13(2): 176-72 
 
14. 
Berger D. Prevention of parastomal hernias by prophylactic use of a 
specially designed intraperitoneal onlay mesh (Dynamesh IPST®). 
Hernia 2008; 12:243-246 
 
15. 
DynaMesh® Product information.  Female urinary incontinence and 
pelvic floor descent. FEG Textiltechnik mbH Aachen, Germany 2014 
 
 

Research Protocol 
Safety 
and 
efficacy 
of 
low 
elasticity 
polyvinylidene 
fluoride 
(DynaMesh®-SIS soft) retropubic tension free midurethral sling in the 
treatment of stress urinary incontinence in women. 
 
Version Number 1.5 
4 April 2016 
35 
 
 
APPENDICES 
Permission to Contact – Version 1.1 (Attached as separate document) 
Participant Information Sheet - Version 1.5(Attached as separate 
document) 
Participant Consent Form - Version 1.2 (Attached as separate document) 
Letter to GP - Version 1.2 (Attached as separate document) 
Data Collection Form - Version 1.2 (Attached as separate document) 
ICIQ-FLUTS (Attached as separate document) 
ICIQ-LUTSqol questionnaire (Attached as separate document)