Anterior Vaginal Wall Prolapse
Conditions
Keywords
prolapse, anterior colporrhaphy
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.
Interventions
PROCEDUREsmall 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.
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria
Contacts
Primary ContactKsenia Halpern, Dr
Backup ContactEngelbert Hanzal, DR
Outcome results
None listed