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Completed

NCT Number: NCT07144397

Transobturator Lateral Suspension in Anterior Colporrhaphy

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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Key information

Conditions

Anterior Vaginal Wall Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Maribor

Maribor, 2000, Slovenia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOLS

Procedure

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

Primary outcomes

  1. Objective Recurrence Rate

    Time frame: 1 year postoperative

    Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment

Secondary outcomes

  1. Subjective Recurrence Rate

    Time frame: 1 year postoperative

    Subjective recurrence was determined by a positive response to the validated question: "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"

  2. Patient Satisfaction

    Time frame: 1 year postoperative

    5-point Likert scale at 1 year

  3. Operative time

    Time frame: 1 year postoperative

    Measured in minutes during surgery.

  4. Postoperative Pain

    Time frame: 1 year postoperative.

    Assessed via VAS at discharge and immediate postoperative period

  5. Pelvic Sidewall Pain

    Time frame: 1 year postoperative.

    Assessed at 1 year postoperative clinical examination, by pressing on obutrator membrane. Assesed as present or absent.

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

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

Acronym: TLSAC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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