A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
University of Szeged
Szeged, Hungary
Mayanei HaYeshua Medical Center
Bnei Brak, Israel
Asaf HaRofeh Medical Center
Zrifin, Israel
No device related serious adverse events
Time frame: up to 12 month
Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
Time frame: up to 12 months
Improvement in POP-Q: points Aa and Ba
Time frame: up to 12 month
Improvement in POP-Q point C
Time frame: up to 12 months
Achieving normal urinary function
Time frame: up to 12 months
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