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

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

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bnei Brak, Israel, 51544
    • Mayanei HaYeshua Medical Center
  • Safed, Israel
    • Ziv Medical Center
  • Zrifin, Israel, 70300
    • Asaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm; 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; Other Names: transvaginal surgical treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lyra Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: May 1, 2016
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: CD-14-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No