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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 22, 2026 (before its estimated October 4, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 4 of 6 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07271862
Lead Sponsor Riga East Clinical University Hospital
Collaborators: Pauls Stradins Clinical University Hospital, University of Latvia
Conditions
(from sponsor)
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress, Urinary Incontinence (UI), Female Sexual Dysfunction (FSD), Quality of Life
Related terms Pelvic Organ Prolapse, Urinary Incontinence, Urinary Incontinence, Stress
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov