N81
Conditions
Interventions
Group 1: Questionnaire on application of the SRS Implant. All patients of a clinic treated with the SRS Implant may be included.
Sponsors
pfm medical ag
Eligibility
Sex/Gender
Female
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients older than 21 years suffering from symptomatic anterior vaginal and apical Prolapse (POP = stage II).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usability assessment of the SRS Implant during the implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical aspects of the device usage: Occurrence of complications (periprocedural); duration of the procedure (with respect to patient safety/satisfaction) | — |
Countries
Germany, Hungary
Contacts
Public ContactAngelika Greser
pfm medical ag
Outcome results
None listed