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OpenTrials
Completed

NCT Number: NCT03195361

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

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Key information

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayanei HaYeshua Medical Center, Bnei Brak, Israel

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRS - Self Retaining Support system

Device

Other names: transvaginal surgical treatment

Primary outcomes

  1. Improvement in POP-Q points Aa and Ba

    Time frame: 36 months

    Points Aa and\\or Ba are less than -1

  2. Improvement in POP-Q point C:

    Time frame: 36 months

    Point C at -5 or less

  3. No unexpected serious adverse device related events

    Time frame: 36 months

Secondary outcomes

  1. Achieving normal urinary function:

    Time frame: 36 Months

    Patient does not experience voiding dysfunction and have negative Urinary Cough Test.

  2. Improvement in Quality Of Life (QoL)

    Time frame: 36 Months

    Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.

Sponsors and collaborators

Lead sponsor

Lyra Medical Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2017
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.