Sacro-Spinous Ligaments Anterior Apical Anchoring

Pelvic Organ Prolapse Clinical Trial

Official title:

Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842464
• Other study ID #: WesternGalileeH
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: June 17, 2015
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2015
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

Description:

Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 95 Years

Eligibility

Inclusion Criteria:

• Pelvic Floor Prolapse > Gr 2,

• Anterior > Posterior defect,

• Apical Supportive Defect

Exclusion Criteria:

• Active Pelvic Inflammation,

• Patient Refusal

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Anterior Sacro-Spinous
Anterior Sacro-Spinous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change With Distance Between the Vaginal Apex and the Introitus	The change with distance measured by centimeters, between the vaginal apex and the introitus	One year	No
Primary	Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring	Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.	one year	No
Primary	Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure	Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.	one year	No