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 a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86156
    • Universitätsklinikum Augsburg
  • Hagen, Germany, 58135
    • Evangelisches Krankenhaus Hagen-Haspe
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Kiel, Germany, 24116
    • Stadtisches Krankenhaus Kiel
  • Neustadt, Germany, 67434
    • Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße
  • Zittau, Germany, 02763
    • Klinikum Oberlausitzer Bergland gGmbH
  • Hessen
    • Bensheim, Hessen, Germany, 64625
      • Heilig Geist-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system), transvaginal SRS implantation for pelvic organ prolapse surgery

Description

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 §27).
5. Participation in another interventional study concerning pelvic floor reconstruction.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SRS implant; Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: pfm medical gmbh
• Investigators: Principal Investigator: Tina Cadenbach-Blome, Dr. med., Asklepios Klinik Altona

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Homepage Manufacturer with information on the investigational product
• Homepage Sponsor with information on the investigational product

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Pelvic Organ Prolapse; SRS Implant; Surgical Reconstruction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PMCF study SRS implant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No