Small Stitch Study

Not Applicable

• Conditions: Anterior Vaginal Wall Prolapse
• Interventions: Procedure: small stitch anterior colporrhaphy

• Registration Number: NCT02469584
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-10
• Status Verified: 2015-06
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-08
• Last Update Submitted: 2015-06-08
• Study First Posted: 2015-06-11
• Last Update Posted: 2015-06-11
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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)

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Exclusion Criteria

• previous urogynecological operation
• gynecologic malignancy
• planned concomitant incontinence operation
• other contraindications for surgery
• pregnancy
• systemic glucocorticoid treatment
• contraindication for the surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	small stitch anterior colporrhaphy	symptomatic cystocele described as Points Aa or Ba \>= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.

Primary Outcome Measures

Name	Time	Method
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)	4-6 weeks, 3 months	The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria