Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
|Condition or Disease||Intervention/Treatment||Phase|
National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.
Arms and Interventions
Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
Primary Outcome Measures
- Patient´s Quality of Life [12 months]
Evaluation of changes in quality of life twelve months after implantation of the SRS implant compared to baseline. Quality of Life was assessed by the P-QOL (Prolapse Quality of Life Questionnaire). The P-QOL yields a domain score in the range from zero to 100, wheras a score of zero is the best.
Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention.
Age ≥ 21 years.
Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
Patient information has been provided and written consent exists.
Contraindications according to the manufacturer's instructions for use.
Patient with previous urogynaecological surgeries with alloplastic material.
Patient with radiological treatment in the pelvic floor.
Patient is institutionalised by court or official order (MPDG §27).
Participation in another interventional study concerning pelvic floor reconstruction.
Contacts and Locations
|2||Evangelisches Krankenhaus Hagen-Haspe||Hagen||Germany||58135|
|3||Asklepios Klinik Altona||Hamburg||Germany||22763|
|4||Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße||Neustadt||Germany||67434|
|6||Klinik Tettnang GmbH||Tettnang||Germany||88069|
|7||Klinikum Oberlausitzer Bergland gGmbH||Zittau||Germany||02763|
Sponsors and Collaborators
- pfm medical ag
- Principal Investigator: Tina Cadenbach-Blome, Dr. med., Asklepios Klinik Altona
Study Documents (Full-Text)None provided.
- Homepage Manufacturer with information on the investigational product
- Homepage Sponsor with information on the investigational product
- Levy G, Padoa A, Fekete Z, Bartfai G, Pajor L, Cervigni M. Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J. 2018 May;29(5):709-714. doi: 10.1007/s00192-017-3415-3. Epub 2017 Jul 14.
- Levy G, Padoa A, Marcus N, Beck A, Fekete Z, Cervigni M. Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:55-59. doi: 10.1016/j.ejogrb.2020.01.005. Epub 2020 Jan 9.
- PMCF study SRS implant