Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Study Overview
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Brief Summary
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A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Detailed Description
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The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses

Conditions
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Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent

Intervention / Treatment
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* Device: SRS - Self Retaining Support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. Patient age is between 50 and 75 years old POP-Q: Aa and/or Ba is at least -1 Exclusion Criteria: Patient is pregnant or breastfeeding Patient is suffering from active infection (on antibiotic therapy) Patient is planning vaginal delivery Patient had previous vaginal mesh surgery Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases). Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results. Malignancy. Known hypersensitivity to PEEK and/or polypropylene materials. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation. Diagnosed with mental or emotional disturbance.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm<br>Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device | Device: SRS - Self Retaining Support system<br> <br> * Other names: transvaginal surgical treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in POP-Q points Aa and Ba | Points Aa and\or Ba are less than -1 | 36 months | 
| Improvement in POP-Q point C: | Point C at -5 or less | 36 months | 
| No unexpected serious adverse device related events |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving normal urinary function: | Patient does not experience voiding dysfunction and have negative Urinary Cough Test. | 36 Months | 
| Improvement in Quality Of Life (QoL) | Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12. | 36 Months |