Post-market Clinical Follow-up of the SRS Implant

Active, not recruiting

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT05170074
• Lead Sponsor: pfm medical gmbh

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-27
• Study Start: 2022-04-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 175

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Heilig Geist-Hospital; 🇩🇪 Bensheim, Hessen, Germany

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, 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, Germany