Urinary Stress IncontinenceNCT02407145
Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
An observational study of Urinary Stress Incontinence and Urinary Incontinence,Stress, run by Julie Dawson at 10 sites in 2 countries.
Trial 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 in women. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence, Urinary Incontinence,Stress
- What is being tested?
- 24 month follow up of women with validated questionnaire
- How many people
- 218 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2016to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women presenting with urinary incontinence, presenting to the research centres through normal referral pathways
Who may be able to join
- women with proven urodynamic stress incontinence in whom a retropubic midurethral sling is appropriate treatment as per the treating urogynaecologist, gynaecologist or urologist
- women who have not had a previous incontinence procedure
- no concomitant prolapse procedure at the time of sling placement
Who cannot join
- urodynamic studies negative for stress urinary incontinence
- previous incontinence procedures
- non English/non German speaker depending on study centre
- lack capacity to consent
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom8 sites
South Eastern Health and Social Care Trust
Belfast, BT16 1RH
Addenbrooke's Hospital
Cambridge, Cambrigeshire, CB2 0QQ
Hichingbooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT
NHS Ayrshire & Arran
Kilmarnock, KA2 0BE
University College Hospital
London, NW1 2BU
Wirral University Teaching Hospital NHS Foundation
Metropolitan Borough of Wirral, CH49 5PE
Norfolk and Norwich University Hospitals Trust
Norwich, NR4 7UY
Heart of England NHS Foundation Trust
Solihull, B91 1PS
Germany2 sites
Chirurgische Klinik
Munich, 81679
Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official 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
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 in women. Women who are having a retropubic PVDF midurethral sling for urodynamic stress incontinence will be followed up for 24 months to address its efficacy and rate of complications.
Read the detailed description
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.
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) has been used since 1996 using a polypropylene mesh.(1) The use of permanent mesh in gynaecology has come under scrutiny due to significant complications for women.(2) This year the Medicines and Healthcare Products Regulatory Agency (MHRA), UK concluded that there is not enough evidence to withdraw mesh from clinical usage.(3)
The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.(4) Each sling is individually woven and and has low elasticity meaning dimensions are maintained under tension, such as with coughing or straining. The technique of retropubic placement of the DynaMesh®SIS soft does not differ from current retropubic TVT placement.
The hypothesis is that the low elasticity polyvinylidene fluoride midurethral sling is non-inferior in both safety and efficacy compared with the safety and efficacy of traditional polypropylene slings, as reported in current literature.
There are eleven research centres in two countries, The United Kingdom and Ireland. The DynaMesh®SIS soft sling is currently in use in four of eleven of the research hospitals, Norwich (main research centre), Antrim and Belfast in the UK and in Munich in Germany. It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK and Wurzbug in Germany.
Women with urodynamic stress incontinence who are already assigned to have this retropubic midurethral tape placed for treatment will be recruited prior to their procedure for ongoing follow up. Participants will 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.
- Being tested
- 24 month follow up of women with validated questionnaire
- Keywords
- retropubic, midurethral sling, polyvinylidene fluoride
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 month follow up of women with validated questionnaireOther
24 month follow up (clinical and questionnaire based) of women who are already assigned to have a PVDF retropubic midurethral sling (DynaMesh®-SIS soft) as a part of their planned treatment of urodynamic stress incontinence.
| Study group | Role | What they receive |
|---|---|---|
| PVDF retropubic midurethral sling | Women with urodynamic stress urinary incontinence having a retropubic polyvinylidene fluoride midurethral sling (DynaMesh®-SIS soft). Receives: Other: 24 month follow up of women with validated questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.
Measured: 3 to 24 months
The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.
Measured: 3 to 24 months
Secondary outcomes (3)
Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.
Measured: 3 to 24 months
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.
Measured: 3 to 24 months
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.
Measured: 3-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMar 2016
- Primary completion1 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Collaborators
- Kebomed UK
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- Sambit Mukhopadhyay, Principal investigator, Norfolk and Norwich University Hospital TrustEdward P Morris, Study chair, Norfolk and Norwich University Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407145
- Sponsor's protocol ID
- 2015O&G01M
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2015
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
PubMed 8798092U.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011
A summary of the evidence on the benefits and risks of vaginal mesh implants. October 2014. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
Klinge U, Binneboesel M, Kuschel S, Schuessler B. Demands and properties of alloplastic implants for the treatment of stress urinary incontinence. Expert Rev Med Devices. 2007 May;4(3):349-59. doi: 10.1586/17434440.4.3.349.
PubMed 17488229
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02407145
- Acronym / sponsor ID
- 2015O&G01M
- Keywords
- retropubic, midurethral sling, polyvinylidene fluoride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Collaborators
- Kebomed UK
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in women. Women who are having a retropubic PVDF midurethral sling for urodynamic stress incontinence will be followed up for 24 months to address its efficacy and rate of complications.
Detailed description
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.
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) has been used since 1996 using a polypropylene mesh.(1) The use of permanent mesh in gynaecology has come under scrutiny due to significant complications for women.(2) This year the Medicines and Healthcare Products Regulatory Agency (MHRA), UK concluded that there is not enough evidence to withdraw mesh from clinical usage.(3)
The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.(4) Each sling is individually woven and and has low elasticity meaning dimensions are maintained under tension, such as with coughing or straining. The technique of retropubic placement of the DynaMesh®SIS soft does not differ from current retropubic TVT placement.
The hypothesis is that the low elasticity polyvinylidene fluoride midurethral sling is non-inferior in both safety and efficacy compared with the safety and efficacy of traditional polypropylene slings, as reported in current literature.
There are eleven research centres in two countries, The United Kingdom and Ireland. The DynaMesh®SIS soft sling is currently in use in four of eleven of the research hospitals, Norwich (main research centre), Antrim and Belfast in the UK and in Munich in Germany. It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK and Wurzbug in Germany.
Women with urodynamic stress incontinence who are already assigned to have this retropubic midurethral tape placed for treatment will be recruited prior to their procedure for ongoing follow up. Participants will 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVDF retropubic midurethral sling | – | Other: 24 month follow up of women with validated questionnaireWomen with urodynamic stress urinary incontinence having a retropubic polyvinylidene fluoride midurethral sling (DynaMesh®-SIS soft). |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting with urinary incontinence, presenting to the research centres through normal referral pathways
Key inclusion criteria (3 listed)
- women with proven urodynamic stress incontinence in whom a retropubic midurethral sling is appropriate treatment as per the treating urogynaecologist, gynaecologist or urologist
- women who have not had a previous incontinence procedure
- no concomitant prolapse procedure at the time of sling placement
Key exclusion criteria (4 listed)
- urodynamic studies negative for stress urinary incontinence
- previous incontinence procedures
- non English/non German speaker depending on study centre
- lack capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 month follow up of women with validated questionnaire24 month follow up (clinical and questionnaire based) of women who are already assigned to have a PVDF retropubic midurethral sling (DynaMesh®-SIS soft) as a part of their planned treatment of urodynamic stress incontinence. | Other | PVDF retropubic midurethral sling |
Primary outcome
The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.
Time frame: 3 to 24 months
The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.
Time frame: 3 to 24 months
3 secondary outcomes
Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.
Time frame: 3 to 24 months
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.
Time frame: 3 to 24 months
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.
Time frame: 3-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 8798092Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
- BackgroundU.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011
- BackgroundA summary of the evidence on the benefits and risks of vaginal mesh implants. October 2014. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
- Background: PubMed 17488229Klinge U, Binneboesel M, Kuschel S, Schuessler B. Demands and properties of alloplastic implants for the treatment of stress urinary incontinence. Expert Rev Med Devices. 2007 May;4(3):349-59. doi: 10.1586/17434440.4.3.349.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sambit Mukhopadhyay principal investigator
Norfolk and Norwich University Hospital Trust
Edward P Morris study chair
Norfolk and Norwich University Hospital Trust
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stress Incontinence and Urinary Incontinence,Stress, run by Julie Dawson at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence. (time frame: 3 to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407145, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.