Post-market Clinical Follow-up of the SRS Implant

NCT05170074 | Active Not Recruiting DMC

• 1 other identifier: PMCF study SRS implant
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Keywords

SRS Implant; Quality of Life; Pelvic Organ Prolapse; Surgical Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SRS implant

Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• pfm medical gmbh: lead

Study Sites (7)

Heilig Geist-Hospital

Bensheim, Hesse, 64625, Germany

Location

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Evangelisches Krankenhaus Hagen-Haspe

Hagen, 58135, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Städtisches Krankenhaus Kiel

Kiel, 24116, Germany

Location

Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße

Neustadt, 67434, Germany

Location

Klinikum Oberlausitzer Bergland gGmbH

Zittau, 02763, Germany

Location

Related Publications (2)

• 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.

  PMID: 31954369 BACKGROUND

• 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.

  PMID: 28710613 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tina Cadenbach-Blome, Dr. med.

  Asklepios Klinik Altona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 27, 2021
• Study Start: April 7, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)