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NCT05170074 Clinical Trial

Post-market Clinical Follow-up of the SRS Implant

Pelvic Organ Prolapse Clinical Trial

Official title:
National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05170074
Other study ID # PMCF study SRS implant
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 7, 2022
Est. completion date September 2025

Study information
Verified date April 2024
Source pfm medical gmbh
Contact Angelika Greser, Dr. rer. med.
Phone +4922369641251
Email angelika.greser@pfmmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 175
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. Age = 21 years. 3. Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study. 4. Patient information has been provided and written consent exists. Exclusion Criteria: 1. Contraindications according to the manufacturer's instructions for use. 2. Patient with previous urogynaecological surgeries with alloplastic material. 3. Patient with radiological treatment in the pelvic floor. 4. Patient is institutionalised by court or official order (MPDG ยง27). 5. Participation in another interventional study concerning pelvic floor reconstruction.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitätsklinikum Augsburg Augsburg
Germany Heilig Geist-Hospital Bensheim Hessen
Germany Evangelisches Krankenhaus Hagen-Haspe Hagen
Germany Asklepios Klinik Altona Hamburg
Germany Städtisches Krankenhaus Kiel Kiel
Germany Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße Neustadt
Germany Klinikum Oberlausitzer Bergland gGmbH Zittau

Sponsors (1)
Lead Sponsor Collaborator
pfm medical gmbh

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Patient´s Quality of Life 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. 12 months
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