Post-market Clinical Follow-up of the 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.

Inclusion criteria

• 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.
• Age ≥ 21 years.
• Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
• Patient information has been provided and written consent exists.

Exclusion criteria

• Contraindications according to the manufacturer's instructions for use.
• Patient with previous urogynaecological surgeries with alloplastic material.
• Patient with radiological treatment in the pelvic floor.
• Patient is institutionalised by court or official order (MPDG §27).
• Participation in another interventional study concerning pelvic floor reconstruction.