Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Crolll Gmbh | OTHER |
| Bayes GmbH | OTHER |
| Aix Scientifics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TiLOOP® PRO Plus A | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Adverse Events (AE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Fünfgeld, Dr. med. | Klinik Tettnang GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Tettnang GmbH | Tettnang | Baden-Wurttemberg | 88069 | Germany | ||
| Klinikum Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31523096 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D052858 | Cystocele |
| D014596 | Uterine Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. | 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. | 1 day |
| Augsburg |
| Bavaria |
| 86156 |
| Germany |
| Klinikum Dresden-Friedrichstadt | Dresden | Saxony | 01067 | Germany |
| Klinikum Oberlausitzer Bergland gemeinnützige GmbH | Zittau | Saxony | 02763 | Germany |
| Ev. Amalie-Sieveking-Krankenhaus | Hamburg | 22359 | Germany |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |