Post-market Clinical Follow-up of the SRS Implant

N/AActive Not RecruitingNCT05170074

pfm medical gmbh175 enrolled

Overview

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

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

175

Conditions

Pelvic Organ Prolapse

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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