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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05170074

Enrollment

175

Registered

2021-12-27

Start date

2022-04-07

Completion date

2026-09-30

Last updated

2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results