Single Incision Pelvic Floor Mesh Implants

NCT ID: NCT01909700

Last Updated: 2016-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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

Conditions

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Intra-operative Complications Post Operative Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Incision Mesh

intervention: single incision mesh implantation

Group Type EXPERIMENTAL

Single Incision Mesh

Intervention Type DEVICE

Single Incision Mesh is implanted for pelvic floor reconstruction

Interventions

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Single Incision Mesh

Single Incision Mesh is implanted for pelvic floor reconstruction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion Criteria

\*Previous Pelvic irradiation
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menahem Neuman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Western Galilee MC Nahariya

Locations

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Assuta MC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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2011041

Identifier Type: -

Identifier Source: org_study_id

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