Post-market Clinical Follow-up of the SRS Implant

Sponsor
pfm medical ag (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05170074
Collaborator
(none)
175
Enrollment
7
Locations
41.3
Anticipated Duration (Months)
25
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    175 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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)
    Actual Study Start Date :
    Mar 23, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2025

    Arms and Interventions

    ArmIntervention/Treatment
    SRS implant

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Universitätsklinikum AugsburgAugsburgGermany86156
    2Evangelisches Krankenhaus Hagen-HaspeHagenGermany58135
    3Asklepios Klinik AltonaHamburgGermany22763
    4Marienhaus Klinikum Hetzelstift Neustadt/WeinstraßeNeustadtGermany67434
    5Klinik PreetzPreetzGermany24211
    6Klinik Tettnang GmbHTettnangGermany88069
    7Klinikum Oberlausitzer Bergland gGmbHZittauGermany02763

    Sponsors and Collaborators

    • pfm medical ag

    Investigators

    • Principal Investigator: Tina Cadenbach-Blome, Dr. med., Asklepios Klinik Altona

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    pfm medical ag
    ClinicalTrials.gov Identifier:
    NCT05170074
    Other Study ID Numbers:
    • PMCF study SRS implant
    First Posted:
    Dec 27, 2021
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by pfm medical ag
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022