NCT07144397

Transobturator Lateral Suspension in Anterior Colporrhaphy

Does Concomitant Transobturator Lateral Suspension Improve Anterior Colporrhaphy Outcomes? A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University Medical Centre Maribor · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. In a cohort of 44 women (POP-Q ≥ 2), AC alone was compared to AC+TOLS over a 1-year follow-up. Results showed significantly lower objective recurrence with the added suspension.

Detailed description

Conducted prospectively at University Medical Centre Maribor (Slovenia), this single-surgeon RCT randomized women with symptomatic anterior vaginal prolapse (POP-Q stage ≥ 2) to receive either standard AC or AC plus bilateral TOLS via non-absorbable suture across the obturator foramen. Primary outcome was objective anatomical recurrence (POP-Q ≥ 2) at 1 year. Secondary outcomes included subjective recurrence, satisfaction (Likert), operative time, postoperative and pelvic sidewall pain, and validated QOL instruments (UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, POPDI-6, UDI-6, PFDI, PISQ).

Conditions

• Anterior Vaginal Wall Prolapse
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	TOLS	"Standard AC plus bilateral lateral suspension using non-absorbable sutures passed through the obturator foramen to support lateral vaginal wall."

Timeline

• Start date: 2020-10-09
• Primary completion: 2024-10-23
• Completion: 2024-11-23
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Slovenia