Post-market surveillance study on SRS Implant

• Conditions: N81; Female genital prolapse

• Registration Number: DRKS00016753
• Lead Sponsor: pfm medical ag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-28
• Study Completion: 2020-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

Patients older than 21 years suffering from symptomatic anterior vaginal and apical Prolapse (POP = stage II).

Exclusion Criteria

Exclusion criteria result from the contraindications listed in the manufacturer’s IFU based on their technical documentation. The SRS Implant is contraindicated for use in any patient in whom soft tissue implants are contraindicated. In addition, patients with:
• Pathology of the pelvic soft tissue;
• Pregnant patients, or patients that are considering future pregnancies;
• Any pathology, including known or suspected uterine/cervical/vaginal/bladder pathology, which would compromise placement (e.g. anatomical distortion or abnormalities);
• Any pathology that would limit blood supply and compromise healing (e.g. decreased blood supply to organs because of treatments such as radiation therapy, chemotherapy);
• Presence of known or suspected cancer of the vagina, cervix, bladder or uterus;
• Blood coagulation disorder;
• Autoimmune connective tissue disease;
• Renal insufficiency and urinary tract obstruction;
• Pre-existing local or systemic infection (note: treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the SRS Implant);
• And sensitivity/allergy to polypropylene or titanium-dioxide or polyether ether ketone (PEEK).
Furthermore, patients with a mesh already implanted are excluded.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sability assessment of the SRS Implant during the implantation

Secondary Outcome Measures

Name	Time	Method
Clinical aspects of the device usage:<br>Occurrence of complications (periprocedural);<br>duration of the procedure (with respect to patient safety/satisfaction)