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Post-market Clinical Follow-up of the SRS Implant | Clinical Trials | Clareo Health

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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)

NCT05170074•pfm medical gmbh

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (7)

Heilig Geist-Hospital

Bensheim, Hesse, 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

Key Dates

Start Date

April 7, 2022

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2026

Last Updated

April 2, 2025

Enrollment

175

ESTIMATED participants

Conditions

Pelvic Organ Prolapse

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

NCT05602246

Pelvic Organ ProlapseCystocele+1 more

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RECRUITING

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

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Pelvic Organ Prolapse

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Post-market Clinical Follow-up of the SRS Implant

Inclusion Criteria

Exclusion Criteria

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse

Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

EASE: The Materna Prep Pivotal Study