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

Not Applicable

Completed

• Conditions: Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
• Interventions: Device: SRS - Self Retaining Support system

• Registration Number: NCT03195361
• Lead Sponsor: Lyra Medical Ltd.

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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	SRS - Self Retaining Support system	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Asaf HaRofeh Medical Center; 🇮🇱 Zrifin, Israel

Mayanei HaYeshua Medical Center; 🇮🇱 Bnei Brak, Israel

Ziv Medical center; 🇮🇱 Safed, Israel