NCT02536001

Brief Summary

The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 31, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

July 6, 2015

Last Update Submit

August 26, 2015

Conditions

Pelvic Organ Prolapse

Keywords

Vaginal meshTotal vaginal lengthQuality of life

Outcome Measures

Primary Outcomes (4)

  • Vaginal length between the arms

    measure total vaginal length after surgery

    2 years

  • Quality of life

    use validated questionnaires before and after surgery

    2 years

  • Complications rate

    comparing complications rate between groups

    2 years

  • Sexual function

    use validated questionnaires before and after surgery

    2 years

Secondary Outcomes (2)

  • To examine anatomical results

    2 years

  • Success rate of uterus preservation

    2 years

Study Arms (2)

One mesh Endofast reliant system

OTHER

Patients with anterior compartment stage III and uterus prolapse grade II will be treated with one mesh - Anterior Endofast reliant system (fixation of posterior arms to the sacrospinous ligament)

Device: One mesh Endofast reliant system

two meshes Endofast reliant system

OTHER

intervention: Patients with anterior compartment stage III and uterus prolapse grade II will be treated with 2 meshes: anterior Endofast reliant system mesh to correct the anterior compartment and posterior Endofast reliant system mesh to correct the apical prolapse (fixation to the sacrospinous ligament)

Device: two meshes Endofast reliant system

Interventions

One mesh Endofast reliant systemDEVICE

One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse

One mesh Endofast reliant system
two meshes Endofast reliant systemDEVICE

Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment

two meshes Endofast reliant system

Eligibility Criteria

Age30 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least anterior compartment prolapse stage III and uterine prolapse stage II.

You may not qualify if:

  • Women without uterine prolapse, or with uterine prolapse \< stage 2.
  • Women with uterine prolapse \> stage 2.
  • Hysterectomy in the past.
  • Women with an indication for hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Naama Marcus Braun, MD

    Ziv Medical center, Israel

    STUDY CHAIR

Central Study Contacts

Naama Marcus braun, MD

CONTACT

+972506266090naama.m@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

August 31, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2018

Last Updated

August 31, 2015

Record last verified: 2015-05