Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Conditions
Brief summary
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
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
Interventions
DEVICESRS - Self Retaining Support system
Sponsors
Lyra Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. 2. Patient age is between 50 and 75 years old 3. POP-Q: Aa and/or Ba is at least -1
Exclusion criteria
1. Patient is pregnant or breastfeeding 2. Patient is suffering from active infection (on antibiotic therapy) 3. Patient is planning vaginal delivery 4. Patient had previous vaginal mesh surgery 5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases). 6. 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. 7. Malignancy. 8. Known hypersensitivity to PEEK and/or polypropylene materials. 9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation. 10. Diagnosed with mental or emotional disturbance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in POP-Q points Aa and Ba | 36 months | Points Aa and\\or Ba are less than -1 |
| Improvement in POP-Q point C: | 36 months | Point C at -5 or less |
| No unexpected serious adverse device related events | 36 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality Of Life (QoL) | 36 Months | Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12. |
| Achieving normal urinary function: | 36 Months | Patient does not experience voiding dysfunction and have negative Urinary Cough Test. |
Countries
Israel
Outcome results
None listed