ational, 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)

Recruiting

• Conditions: N81; Female genital prolapse

• Registration Number: DRKS00025856
• Lead Sponsor: pfm medical gmbh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 175

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) 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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of changes in quality of life (P-QOL) twelve months after implantation of the SRS implant compared to baseline.

Secondary Outcome Measures

Name	Time	Method
• Anatomical result in the apical and anterior compartment measured by the POP-Q system.<br>• Evaluation of changes in quality of life assessed by the P-QoL six and 24 months after implantation of the SRS implant compared to baseline.<br>• Complication rate during and after implantation of an SRS implant, measured by adverse events during the study period.<br>• Feasibility and duration of the study surgery, and blood loss during surgery.<br>• Stress urinary incontinence, determined by ICIQ questionnaire, before and after study surgery.