An interventional study of Laparoscopic sacrocolpopexy. and Laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues. in Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress and Urinary Incontinence (UI), sponsored by Riga East Clinical University Hospital. Active, not recruiting at 1 site in Latvia. Open to female participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Riga East Clinical University Hospital · Not applicable, Interventional, and Treatment
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.
This is a prospective randomized study conducted at Riga East University Hospital (Latvia) and Pauls Stradins Clinical University Hospital (Latvia). Two groups of female patients will be compared. In the first group, patients will undergo laparoscopic reconstructive pelvic organ prolapse surgery using a polypropylene implant according to the 'classical' technique, involving fixation to the levator ani muscle and promontofixation. In the second group, patients will undergo a novel laparoscopic reconstructive pelvic organ prolapse procedure using a polypropylene implant based on a 'modified' technique, consisting of laparoscopic apical promontofixation combined with vaginal and perineal tissue repair using native tissues.
Group1 (Classical technique): Half of the patients will undergo 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.
Group2 (Modified technique): Half of the patients will undergo 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 MacCall 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.
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 Pelvic Organ Prolapse Quantification System classification. Functional outcomes will be assessed using standardized questionnaires, including Pelvic Floor Distress Inventory-20, Female Sexual Function Index, and International Consultation on Incontinence Questionnaire, in addition to urodynamic testing. Anatomical and functional results, quality of life, and sexual activity will be analyzed over a 6-month postoperative follow-up period.
Based on the study results, the novel laparoscopic apical promontofixation technique with simultaneous perineal repair using native tissues will be introduced into clinical practice in hospitals providing gynecological care. Furthermore, a new unified clinical protocol will be developed to facilitate practical application, including a simplified diagnostic algorithm based on 4-6 key symptoms, enabling family physicians and outpatient gynecologists to identify women with pelvic organ prolapse and refer them for specialist evaluation and appropriate treatment planning.
Additionally, a new objective method for assessing the degree of prolapse will be developed, allowing specialists to more accurately measure anterior, posterior, and central vaginal wall defects. This method will involve specific markings on a gynecological plastic speculum, enabling more precise evaluation of vaginal wall defects during routine gynecological examination. The new method will also be compared with other internationally recognized approaches for surgical management of pelvic organ prolapse.
509 studies on the registry are indexed under Pelvic Organ Prolapse; 81 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 330 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Riga East Clinical University Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic sacrocolpopexy.
Procedure: Laparoscopic sacrocolpopexy.
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.
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.
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.
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).
Time frame: Before and 6 months after surgery.
Functional outcome - pelvic floor symptoms.
Evaluation with standardized questionnaires: Pelvic Floor Distress Inventory (PFDI-20). Unit of Measure: PFDI-20 score (0-300).
Time frame: Before and 6 months after surgery.
Sexual function.
Female Sexual Function Index (FSFI) questionnaire to assess sexual activity and satisfaction. Unit of Measure: FSFI score (2-36).
Time frame: Before and 6 months after surgery.
Urinary function.
International Consultation on Incontinence Questionnaire (ICIQ) and urodynamic testing. Unit of Measure: ICIQ score (0-21); presence/absence of urodynamic abnormalities.
Time frame: Before and 6 months after surgery.
Postoperative complications.
Frequency and severity of intraoperative and postoperative complications (classified according to Clavien-Dindo). Unit of Measure: Number of events and severity grade.
Time frame: Early (within 30 days) and late (up to 6 months) after surgery.
Operative time.
Intraoperative.
Time frame: 3 hours.
Length of hospital stay.
From surgery until discharge.
Time frame: 7 Days.
Quality of life.
Assessed using validated patient-reported outcome measures (PFDI-20 global score, condition-specific questionnaires). Unit of Measure: Questionnaire scores.
Time frame: Before and 6 months after surgery.
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Riga East Clinical University Hospital