A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse

Summary

Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%. Up to 20% of women require surgical intervention during their lifetime due to genital prolapse or urinary incontinence. Surgical correction of prolapse provides an immediate effect by restoring the anatomical and physiological position of the pelvic organs, while also improving women's daily quality of life. Approximately 80-90% of women report satisfaction with the outcomes of prolapse surgery. However, there is still no global consensus regarding the optimal technique for performing colposacropexy. Multiple surgical approaches are currently in use, which prevents a definitive evaluation of the best method for surgical management of this condition. The classical laparoscopic sacrocolpopexy technique, while effective, does not eliminate the risk of mesh-related complications, particularly when synthetic implants are placed along the full length of the anterior and posterior vaginal walls.

Therefore, there is a strong rationale for developing a novel, simplified surgical approach for prolapse correction, derived from the original laparoscopic apical promontofixation, with simultaneous correction of cystocele and rectocele. This could potentially improve surgical outcomes for patients with pelvic organ prolapse while reducing the risk of complications associated with synthetic mesh implantation.

Conditions

• Pelvic Organ Prolapse (POP)
• Urinary Incontinence , Stress
• Urinary Incontinence (UI)
• Female Sexual Dysfunction (FSD)
• Quality of Life

Interventions

PROCEDURE

Laparoscopic sacrocolpopexy.

Laparoscopic sacrocolpopexy using a polypropylene mesh implant fixed to the cervix and along the entire anterior vaginal wall up to the bladder neck, with additional fixation along the posterior vaginal wall and to the levator ani muscles, ensuring physiological tension by securing the implant proximally to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. Separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. The following parameters will be analyzed: frequency and severity of intraoperative and postoperative complications (early and late), duration of surgery, length of hospital stay, recurrence rate, sexual activity, quality of life before and after surgery, as well as anatomical and functional outcomes. Anatomical results will be evaluated according to the POP-Q classification. Functional outcomes will be assessed using standardized questionnaires, including PFDI-20, FSFI, ICIQ in addition to urodynamic testing.

PROCEDURE

Laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues.

The procedure includes placement of a polypropylene implant with distal fixation to the bilateral uterosacral ligaments (according to the McCall technique) and to the cervix, as well as along the anterior vaginal wall up to the bladder neck, maintaining physiological tension, with proximal fixation to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. A simultaneous colpoperineolevatoroplasty will also be performed. During the laparoscopic stage, separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. During the vaginal stage, posterior colporrhaphy with simultaneous levatoroplasty for rectocele repair will be performed in patients with posterior vaginal wall prolapse or perineal defects. Parameters will be analyzed: frequency of intraoperative and postoperative complications, duration of surgery, length of hospital stay, sexual activity, quality of life before and after surgery, as well as anatomical and functional results.

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital

  collaborator OTHER

• University of Latvia

  collaborator OTHER

• Riga East Clinical University Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-29

Primary Completion

2026-10-04

Completion

2027-12-31

Countries

• Latvia

Study Locations