N81.1 N81.5 N81.4 N81.6 N81.8
Conditions
Interventions
Group 1: Active comparator, classical technique: Laparoscopic sacrocolpopexy.
Laparoscopic sacrocolpopexy using a polypropylene mesh implant fixed to the cervix and along the entire anterior vaginal
Sponsors
Pauls Stradins Clinical University Hospital
Eligibility
Sex/Gender
Female
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Female patients with symptomatic isolated or combined forms of pelvic organ prolapse, corresponding to stage II–IV according to the POP-Q classification. 2) Age between 30 and 80 years. 3) Presence or absence of urinary incontinence symptoms. 4) Preoperatively verified by urodynamics: occult, mild, or severe stress urinary incontinence, or absence thereof. 5) Presence or absence of proctogenic constipation. 6) No prior surgical interventions for pelvic organ prolapse or urinary incontinence. 7) History of supracervical hysterectomy.
Exclusion criteria
Exclusion criteria: 1) Severe extragenital pathology contraindicating surgical treatment. 2) Malignant pelvic pathology. 3) Asymptomatic patients. 4) Patient refusal to undergo subtotal hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Time Frame: Before and 6 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. 2. 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. 3. 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. 4. 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. 5. Operative time. Intraoperative. Time Frame: Minutes. 6. Length of hospital stay. From surgery until discharge. Time Frame: Days. 7. 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. | — |
Countries
Latvia
Contacts
Public ContactKristians Suspanovs
Pauls Stradins Clinical University Hospital
Outcome results
None listed