Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02690220|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystocele Uterine Prolapse||Device: TiLOOP® PRO Plus A||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
surgical mesh implantation
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.
Device: TiLOOP® PRO Plus A
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.
- 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.
- Patient's Quality of Life [ Time Frame: 6 months ]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.
- Adverse Events (AE) [ Time Frame: 6 weeks, 6 and 12 months ]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.
- Feasibility Check of Mesh implantation [ Time Frame: 1 day ]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.
- Number of complications and concomitant procedures [ Time Frame: 1 day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690220
|Klinik Tettnang GmbH|
|Tettnang, Baden-Württemberg, Germany, 88069|
|Augsburg, Bayern, Germany, 86156|
|Dresden, Sachsen, Germany, 01067|
|Klinikum Oberlausitzer Bergland gemeinnützige GmbH|
|Zittau, Sachsen, Germany, 02763|
|Hamburg, Germany, 22359|
|Principal Investigator:||Christian Fünfgeld, Dr. med.||Klinik Tettnang GmbH|