NCT01909700

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
Last Updated

May 5, 2016

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

July 24, 2013

Last Update Submit

May 4, 2016

Conditions

Intra-operative ComplicationsPost Operative Complications

Keywords

Single Incision, Mesh, Complications

Outcome Measures

Primary Outcomes (1)

  • Operative mesh related complications

    12 Months

Study Arms (1)

Single Incision Mesh

EXPERIMENTAL

intervention: single incision mesh implantation

Device: Single Incision Mesh

Interventions

Single Incision MeshDEVICE

Single Incision Mesh is implanted for pelvic floor reconstruction

Single Incision Mesh

Eligibility Criteria

Age30 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* Patients with Gr 2-3 Pelvic Organ Prolapse

You may not qualify if:

  • \*Previous Pelvic irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta MC

Tel Aviv, 45320, Israel

Location

Study Officials

  • Menahem Neuman, Prof.

    Western Galilee MC Nahariya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

May 5, 2016

Record last verified: 2013-07

Locations

IL(1)