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Clinical Trial Summary

A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.

We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC

Objectives

The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.


Clinical Trial Description

A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02469584
Study type Interventional
Source Medical University of Vienna
Contact Ksenia Halpern, Dr
Phone 00431404040029150
Email ksenia.halpern@meduniwien.ac.at
Status Recruiting
Phase N/A
Start date October 2014
Completion date August 2015

See also
  Status Clinical Trial Phase
Completed NCT02209337 - Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse N/A
Completed NCT01393171 - Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis N/A
Completed NCT00420225 - Mesh Repair of Anterior Vaginal Wall Prolapse Phase 3
Recruiting NCT06429228 - Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy N/A