Small Stitch Study

Medical University of Vienna

Status: Unknown

Conditions: Anterior Vaginal Wall Prolapse

Treatments: Procedure: small stitch anterior colporrhaphy

Study type: Interventional

Funder types: Other

Identifiers

NCT02469584

1236/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Procedure: small stitch anterior colporrhaphy