Small Stitch Study

Anterior Vaginal Wall Prolapse Clinical Trial

Official title:

Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469584
• Other study ID #: 1236/2014
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2015
• Last updated: June 8, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: June 2015
• Source: Medical University of Vienna
• Contact: Ksenia Halpern, Dr
• Phone: 00431404040029150
• Email: ksenia.halpern[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women older than 18 years of age

• Able to read, understand and sign informed consent

• symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)

Exclusion Criteria:

• previous urogynecological operation

• gynecologic malignancy

• planned concomitant incontinence operation

• other contraindications for surgery

• pregnancy

• systemic glucocorticoid treatment

• contraindication for the surgery

Study Design

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

Related Conditions & MeSH terms

• Anterior Vaginal Wall Prolapse
• Prolapse
• Uterine Prolapse

Intervention

Procedure:
• small stitch anterior colporrhaphy
A midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)	The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.	4-6 weeks, 3 months	No