Post-market Clinical Follow-up of the SRS Implant

pfm medical

Status: Active, not recruiting

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Industry

Identifiers

NCT05170074

PMCF study SRS implant

Details and patient eligibility

About

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

Full 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.

Enrollment: 175 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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.

Trial design

175 participants in 1 patient group

SRS implant

Description:

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