NCT07144397

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

August 13, 2025

Last Update Submit

August 23, 2025

Conditions

Anterior Vaginal Wall ProlapsePelvic Organ Prolapse

Keywords

anterior colporrhaphytransobturator lateral suspensionnative tissue repairrandomized controlled trialpelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

  • Objective Recurrence Rate

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

    1 year postoperative

Secondary Outcomes (5)

  • Subjective Recurrence Rate

    1 year postoperative

  • Patient Satisfaction

    1 year postoperative

  • Operative time

    1 year postoperative

  • Postoperative Pain

    1 year postoperative.

  • Pelvic Sidewall Pain

    1 year postoperative.

Study Arms (2)

Anterior Colporrhaphy (AC)

NO INTERVENTION

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

AC + Transobturator Lateral Suspension (TOLS)

EXPERIMENTAL

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

Procedure: TOLS

Interventions

TOLSPROCEDURE

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

AC + Transobturator Lateral Suspension (TOLS)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rok Sumak

    University Medical Centre Maribor, Department of General Gynaecology and Urogynaecology, Maribor, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 27, 2025

Study Start

October 9, 2020

Primary Completion

October 23, 2024

Study Completion

November 23, 2024

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in this article, including baseline characteristics, intraoperative details, and outcome measures (objective recurrence, subjective recurrence, patient satisfaction, operative time, postoperative pain scores, and quality-of-life questionnaire scores), will be available to researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and ending 5 years after article publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Start immediately, until 2027
Access Criteria
Access will be granted to investigators who provide a methodologically sound proposal, subject to approval by the corresponding author and the Institutional Ethics Committee. Data will be shared via a secure institutional repository following signing of a data access agreement.

Locations

SL(1)