Transobturator Lateral Suspension in Anterior Colporrhaphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2024-11-23

Brief Summary

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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.

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Detailed Description

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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

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Anterior Vaginal Wall Prolapse Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anterior Colporrhaphy (AC)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

AC + Transobturator Lateral Suspension (TOLS)

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

Group Type EXPERIMENTAL

TOLS

Intervention Type PROCEDURE

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

Interventions

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TOLS

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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