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OpenTrials
Completed

NCT Number: NCT01909700

Single Incision Pelvic Floor Mesh Implants

Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse.

Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure.

Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

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Key information

Conditions

Intra-operative Complications Post Operative Complications

Age range

30 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assuta MC

Tel Aviv, 45320, Israel

About this study

Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion criteria

*Previous Pelvic irradiation

Treatment and study plan

Single Incision Mesh

Device

Single Incision Mesh is implanted for pelvic floor reconstruction

Primary outcomes

  1. Operative mesh related complications

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
May 5, 2016

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.

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