Transobturator Lateral Suspension in Anterior Colporrhaphy (TLSAC)

University Medical Centre Maribor

Status: Completed

Conditions: Anterior Vaginal Wall Prolapse; Pelvic Organ Prolapse

Treatments: Procedure: TOLS

Study type: Interventional

Funder types: Other

Identifiers

NCT07144397

UKC-MB-KME-10/22

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women with symptomatic anterior vaginal wall prolapse (POP-Q stage ≥ 2)
• Eligible for native tissue repair
• Provided written informed consent

Exclusion criteria

• Previous anterior vaginal wall prolapse repair
• Predominant apical or posterior compartment defect

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Anterior Colporrhaphy (AC)

No Intervention group

Description:

Standard midline plication of pubocervical fascia using absorbable sutures under local anesthesia

AC + Transobturator Lateral Suspension (TOLS)

Experimental group

Description:

In addition to AC, bilateral non-absorbable sutures placed at the lateral edge of the pubocervical fascia, passed through obturator foramen, to provide lateral support

Treatment:

Procedure: TOLS