A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Mayanei HaYeshua Medical Center
Bnei Brak, Israel
Ziv Medical center
Safed, Israel
Asaf HaRofeh Medical Center
Zrifin, Israel
Improvement in POP-Q points Aa and Ba
Points Aa and\\or Ba are less than -1
Time frame: 36 months
Improvement in POP-Q point C:
Point C at -5 or less
Time frame: 36 months
No unexpected serious adverse device related events
Time frame: 36 months
Achieving normal urinary function:
Patient does not experience voiding dysfunction and have negative Urinary Cough Test.
Time frame: 36 Months
Improvement in Quality Of Life (QoL)
Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.
Time frame: 36 Months
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