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

NCT07271862 | Active Not Recruiting

• 1 other identifier: 16-A/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Pelvic organ prolapse; Stress urinary incontinence; Urinary incontinence.; Female sexual dysfunction; Laparoscopic sacropexy; Mesh associated complications

Outcome Measures

Primary Outcomes (1)

• Anatomical success after pelvic organ prolapse surgery.

  Anatomical outcome will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. Success is defined as no prolapse beyond the hymen in any vaginal compartment. Unit of Measure: POP-Q stage (0-4).

  Before and 6 months after surgery.

Secondary Outcomes (6)

• Functional outcome - pelvic floor symptoms.

  Before and 6 months after surgery.

• Sexual function.

  Before and 6 months after surgery.

• Urinary function.

  Before and 6 months after surgery.

• Postoperative complications.

  Early (within 30 days) and late (up to 6 months) after surgery.

• Operative time.

  3 hours.

Other Outcomes (1)

• Quality of life.

  Before and 6 months after surgery.

Study Arms (2)

Classical technique

ACTIVE COMPARATOR

Laparoscopic sacrocolpopexy.

Procedure: Laparoscopic sacrocolpopexy.

Modified technique

SHAM COMPARATOR

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

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

Interventions

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

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.

Modified technique

Laparoscopic sacrocolpopexy. PROCEDURE

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.

Classical technique

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with symptomatic isolated or combined forms of pelvic organ prolapse, corresponding to stage II-IV according to the POP-Q classification.
• Age between 30 and 80 years.
• Presence or absence of urinary incontinence symptoms.
• Preoperatively verified by urodynamics: occult, mild, or severe stress urinary incontinence, or absence thereof.
• Presence or absence of proctogenic constipation.
• No prior surgical interventions for pelvic organ prolapse or urinary incontinence.
• History of supracervical hysterectomy.

You may not qualify if:

• Severe extragenital pathology contraindicating surgical treatment.
• Malignant pelvic pathology.
• Asymptomatic patients.
• Patient refusal to undergo subtotal hysterectomy.

Sponsors & Collaborators

• Riga East Clinical University Hospital: lead
• Pauls Stradins Clinical University Hospital: collaborator
• University of Latvia: collaborator

Study Sites (1)

Riga East Clinical University Hospital. Pauls Stradins Clinical University Hospital.

Riga, Latvia

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 9, 2025
• Study Start: August 29, 2024
• Primary Completion (Estimated): October 4, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

LA (1)