CystoceleNCT02690220
Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh
A study testing TiLOOP® PRO Plus A in people with Cystocele and Uterine Prolapse, run by pfm medical gmbh at 5 sites in Germany.
Trial summary
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life. 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?
- TiLOOP® PRO Plus A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Feb 2016to 31 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- Existence of a cystocele. Women with a symptomatic genital descensus: at least stage II (ICS-classification according POP-Q system). This applies to primary as well as recurrent intervention.
- Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
- Patient information has been handed out and written consent is at hand.
- Patient has attained full age (18 years or older).
Who cannot join
- Unfinished family planning, pregnancy or breast-feeding mother.
- Known intolerance to the mesh-implants under investigation.
- Lack of written patients' informed consent.
- Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- Patients with acute (within the last 12 months) carcinoma in the pelvic area.
- Patients with history of radiotherapy in the pelvic area.
Show all 9Show fewer
- Patients with implanted anterior pelvic floor mesh.
- Patient is institutionalized by court or official order (MPG §20.3).
- Participation in another interventional clinical investigation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinikum Augsburg
Augsburg, Bavaria, 86156
Klinikum Dresden-Friedrichstadt
Dresden, Saxony, 01067
Ev. Amalie-Sieveking-Krankenhaus
Hamburg, 22359
Klinik Tettnang GmbH
Tettnang, Baden-Wurttemberg, 88069
Klinikum Oberlausitzer Bergland gemeinnützige GmbH
Zittau, Saxony, 02763
About this study
Official title: National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
Read the detailed description
This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.
It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.
- Conditions
- Cystocele, Uterine Prolapse
- Being tested
- TiLOOP® PRO Plus A
- 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.
TiLOOP® PRO Plus ADevice
The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms.
| Study group | Role | What they receive |
|---|---|---|
| surgical mesh implantation | Other | Standard method to implant the TiLOOP® PRO A surgical mesh transvaginally. Women with a symptomatic genital descensus: at least stage II (ICS-classification according Pelvic Organ Prolapse Quantification System (POP-Q system)). This applies to primary as well as recurrent intervention. Receives: Device: TiLOOP® PRO Plus A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Quality of Life
By means of a validated questionnaire it will be shown whether the subjective quality of life after 12 months is significantly better than before implantation.
Measured: 12 months
Secondary outcomes (4)
Patient's Quality of Life
The evaluation of changes in quality of life assessed by the P-QoL 6 months after implantation of the TiLOOP® PRO A surgical mesh compared to before implantation.
Measured: 6 months
Adverse Events (AE)
Assessment and analysis of all [serious] adverse events ([S]AEs) during the first 12 months after implantation along with a contextual placement of safety data based on current literature.
Measured: 6 weeks, 6 and 12 months
Feasibility Check of Mesh implantation
To evaluate mesh implantation, information about the duration of the procedure (minutes from cut to stitches) and the operability of the application set (easy, suitable, difficult, no set used) will be collected during the surgery. Taking together, this information will encapsulate the feasibility of the mesh implantation descriptively.
Measured: 1 day
Number of complications and concomitant procedures
Counting the number of intraoperative complications (e. g. lesion of the bladder, the urethra or the intestines) and concomitant procedures (e. g. hysterectomy, colporrhaphy, vaginal sacrospinal fixation) procedure-related adverse events as assessed by CTCAE v4.0 and common concomitant procedures will be evaluated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Crolll Gmbh, Bayes GmbH, Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Christian Fünfgeld, Dr. med., Principal investigator, Klinik Tettnang GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690220
- Sponsor's protocol ID
- pfm15k001 TiLOOP® PRO A
- Status last verified
- Jan 2019
- First submitted
- 5 Feb 2016
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cadenbach-Blome T, Grebe M, Mengel M, Pauli F, Greser A, Funfgeld C. Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh: Final Results of a National, Multicentre Observational Study. Geburtshilfe Frauenheilkd. 2019 Sep;79(9):959-968. doi: 10.1055/a-0984-6614. Epub 2019 Sep 11.
PubMed 31523096
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)
- ClinicalTrials.gov ID
- NCT02690220
- Acronym / sponsor ID
- pfm15k001 TiLOOP® PRO A
- Conditions
- Cystocele, Uterine Prolapse
- Keywords
- polypropylene mesh, prolapse, cystocele, surgical mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Collaborators
- Crolll Gmbh, Bayes GmbH, Aix Scientifics
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Feb 2016 (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 titanized polypropylene mesh on patients quality of life.
Detailed description
This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.
It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical mesh implantation | Other | Device: TiLOOP® PRO Plus AStandard method to implant the TiLOOP® PRO A surgical mesh transvaginally. Women with a symptomatic genital descensus: at least stage II (ICS-classification according Pelvic Organ Prolapse Quantification System (POP-Q system)). This applies to primary as well as recurrent intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Existence of a cystocele. Women with a symptomatic genital descensus: at least stage II (ICS-classification according POP-Q system). This applies to primary as well as recurrent intervention.
- Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
- Patient information has been handed out and written consent is at hand.
- Patient has attained full age (18 years or older).
Key exclusion criteria (9 listed)
- Unfinished family planning, pregnancy or breast-feeding mother.
- Known intolerance to the mesh-implants under investigation.
- Lack of written patients' informed consent.
- Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- Patients with acute (within the last 12 months) carcinoma in the pelvic area.
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 |
|---|---|---|
| TiLOOP® PRO Plus AThe standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms. | Device | surgical mesh implantation |
Primary outcome
Patient's Quality of Life
Time frame: 12 months
By means of a validated questionnaire it will be shown whether the subjective quality of life after 12 months is significantly better than before implantation.
4 secondary outcomes
Patient's Quality of Life
Time frame: 6 months
Adverse Events (AE)
Time frame: 6 weeks, 6 and 12 months
Feasibility Check of Mesh implantation
Time frame: 1 day
Number of complications and concomitant procedures
Time frame: 1 day
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 23 Oct 2019.
- Background: PubMed 31523096Cadenbach-Blome T, Grebe M, Mengel M, Pauli F, Greser A, Funfgeld C. Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh: Final Results of a National, Multicentre Observational Study. Geburtshilfe Frauenheilkd. 2019 Sep;79(9):959-968. doi: 10.1055/a-0984-6614. Epub 2019 Sep 11.
- 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. med. principal investigator
Klinik Tettnang GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiLOOP® PRO Plus A in people with Cystocele and Uterine Prolapse, run by pfm medical gmbh at 5 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 4 inclusion and 9 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Patient's Quality of Life (time frame: 12 months). 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 NCT02690220, which also lists 1 linked publication.
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 23 Oct 2019.