CystoceleNCT01084889
Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
An observational study of Cystocele and Uterine Prolapse, run by pfm medical gmbh at 9 sites in Germany.
Trial summary
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystocele, Uterine Prolapse
- What is being tested?
- surgical mesh implantation (TiLOOP® Total 6)
- Type of treatment
- Medical device
- How many people
- 292 participants
- Where
- 9 sitesGermany
- Study dates
- Apr 2010to Jun 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a symptomatic genital descensus treated in the center
Who may be able to join
- Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
- Existence of a cystocele.
- Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- Patient information has been handed out and all written consents are at hand.
- Patient has attained full age.
Who cannot join
- Pregnancy or unfinished family planning.
- Known intolerance to the mesh-implants under investigation.
- Patients with acute (last 12 months) carcinoma.
- Patients with history of radiotherapy in the pelvic area.
- Genital descensus without any complaints.
- Patients with implanted pelvic floor mesh.
Show all 11Show fewer
- Systemic steroid treatment.
- Lack of written patients' informed consent.
- Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- Patient is institutionalised by court or official order (MPG §20.3).
- Participation in another clinical investigation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Berliner Kontinenzzentrum am Franziskus Krankenhaus,
Berlin, 10787
Krankenhaus Dresden- Friedrichsstadt
Dresden, 01067
Evangelisches Diakoniekrankenhaus Freiburg
Freiburg im Breisgau
Universitätsklinikum Eppendorf
Hamburg, 20246
St. Elisabeth Krankenhaus Leipzig,
Leipzig, 04277
Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg
Ludwigsburg, 71640
Beckenbodenzentrum München
München, 81679
Klinik Tettnang GmbH
Tettnang, 88069
Klinikum Oberlausitzer Bergland gGmbH,
Zittau, 02763
About this study
Official title: National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
Read the detailed description
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.
It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.
- Conditions
- Cystocele, Uterine Prolapse
- Being tested
- surgical mesh implantation (TiLOOP® Total 6)
- Keywords
- polypropylene mesh, Prolapse, Cystocele, Surgical Mesh
- Medical subject headings
- Cystocele, Uterine Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical mesh implantation (TiLOOP® Total 6)Device
Also called TiLOOP® Total 6
The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic genital descensus | Women with a symptomatic genital descensus : at least stage II (ICS-classification according pelvic organ prolapse quanification (POP-Q) system), or stage I with a symptomatic requiring intervention.
Standard method to implant the TiLOOP® Total 6 surgical mesh transvaginally. Receives: Device: surgical mesh implantation (TiLOOP® Total 6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erosion rate
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Measured: 12 months
Patient's quality of life
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.
Measured: 6 months
Secondary outcomes (4)
Adverse Events
Documentation and independent evaluation of all complications.
Measured: at 6, 12, 36 months
Feasibility of the mesh implantation
Evaluation of questions on usability.
Measured: 6 months
Erosion rate
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Measured: 36 months
Patient's quality of life
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.
Measured: 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CystoceleStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics, GfE Medizintechnik GmbH, pfm medical titanium gmbh, Bayes GmbH, Crolll Gmbh
- Responsible party
- Sponsor
- Investigators
- Christian Fünfgeld, Dr. MD, Principal investigator, Klinik Tettnang GmbH, Tettnang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084889
- Sponsor's protocol ID
- pfm 10k001 TiLOOP® Total 6
- Status last verified
- Jan 2019
- First submitted
- 10 Mar 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Farthmann J, Mengel M, Henne B, Grebe M, Watermann D, Kaufhold J, Stehle M, Fuenfgeld C. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016 Jul;294(1):115-21. doi: 10.1007/s00404-016-4014-0. Epub 2016 Jan 18.
PubMed 26781262Funfgeld C, Stehle M, Henne B, Kaufhold J, Watermann D, Grebe M, Mengel M. Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):993-1001. doi: 10.1055/s-0043-116857. Epub 2017 Sep 25.
PubMed 28959063
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)
- ClinicalTrials.gov ID
- NCT01084889
- Acronym / sponsor ID
- pfm 10k001 TiLOOP® Total 6
- Conditions
- Cystocele, Uterine Prolapse
- Keywords
- polypropylene mesh, Prolapse, Cystocele, Surgical Mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics, GfE Medizintechnik GmbH, pfm medical titanium gmbh, Bayes GmbH, Crolll Gmbh
- Study start
- Apr 2010 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Mar 2010 (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.
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
Detailed description
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.
It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic genital descensus | – | Device: surgical mesh implantation (TiLOOP® Total 6)Women with a symptomatic genital descensus : at least stage II (ICS-classification according pelvic organ prolapse quanification (POP-Q) system), or stage I with a symptomatic requiring intervention. Standard method to implant the TiLOOP® Total 6 surgical mesh transvaginally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a symptomatic genital descensus treated in the center
Key inclusion criteria (5 listed)
- Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
- Existence of a cystocele.
- Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- Patient information has been handed out and all written consents are at hand.
- Patient has attained full age.
Key exclusion criteria (11 listed)
- Pregnancy or unfinished family planning.
- Known intolerance to the mesh-implants under investigation.
- Patients with acute (last 12 months) carcinoma.
- Patients with history of radiotherapy in the pelvic area.
- Genital descensus without any complaints.
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 |
|---|---|---|
| surgical mesh implantation (TiLOOP® Total 6)Also: TiLOOP® Total 6The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms. | Device | symptomatic genital descensus |
Primary outcome
Erosion rate
Time frame: 12 months
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life
Time frame: 6 months
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.
4 secondary outcomes
Adverse Events
Time frame: at 6, 12, 36 months
Feasibility of the mesh implantation
Time frame: 6 months
Erosion rate
Time frame: 36 months
Patient's quality of life
Time frame: 12 and 36 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 4 Feb 2019.
- Results publication: PubMed 26781262Farthmann J, Mengel M, Henne B, Grebe M, Watermann D, Kaufhold J, Stehle M, Fuenfgeld C. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016 Jul;294(1):115-21. doi: 10.1007/s00404-016-4014-0. Epub 2016 Jan 18.
- Results publication: PubMed 28959063Funfgeld C, Stehle M, Henne B, Kaufhold J, Watermann D, Grebe M, Mengel M. Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):993-1001. doi: 10.1055/s-0043-116857. Epub 2017 Sep 25.
- Quality of life and pelvic organ prolapse-related symptoms after pelvic floor reconstruction with a titanized polypropylene mesh for cystocele: long-term results in a 36 month follow-up by Fünfgeld et al, 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christian Fünfgeld, Dr. MD principal investigator
Klinik Tettnang GmbH, Tettnang
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele and Uterine Prolapse, run by pfm medical gmbh at 9 sites in Germany.
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 5 inclusion and 11 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in 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?
Erosion rate (time frame: 12 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 NCT01084889, which also lists 2 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 4 Feb 2019.