Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study

NCT07552337 | Completed

• 1 other identifier: 683
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.

Conditions

Pelvic Organ Prolapse

Keywords

Uterosacral Ligament Suspension; Vaginal Hysterectomy; Pelvic Organ Prolapse Surgery; Apical Support; Unilateral vs Bilateral

Outcome Measures

Primary Outcomes (1)

• Anatomical Success Rate

  Anatomical success defined as the absence of pelvic organ prolapse at or beyond the hymen, assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.

  12 months postoperatively

Secondary Outcomes (5)

• Prolapse Recurrence Rate

  12 months postoperatively

• Operative Time

  Intraoperative

• Intraoperative Complications

  During surgery

• Postoperative Complications

  Up to 30 days postoperatively

• Functional Outcomes

  6 and 12 months postoperatively

Study Arms (2)

Unilateral High Uterosacral Ligament Suspension

EXPERIMENTAL

Participants undergo unilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse.

Procedure: High Uterosacral Ligament Suspension

Bilateral High Uterosacral Ligament Suspension

EXPERIMENTAL

Participants undergo bilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse.

Procedure: High Uterosacral Ligament Suspension

Interventions

High Uterosacral Ligament Suspension PROCEDURE

High uterosacral ligament suspension is a surgical procedure performed following vaginal hysterectomy to provide apical support in patients with pelvic organ prolapse. In this study, the procedure is performed either unilaterally or bilaterally depending on group assignment.

Bilateral High Uterosacral Ligament Suspension; Unilateral High Uterosacral Ligament Suspension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 years and older
• Diagnosis of pelvic organ prolapse requiring surgical treatment
• Planned vaginal hysterectomy with high uterosacral ligament suspension
• Ability to provide informed consent

You may not qualify if:

• Previous pelvic organ prolapse surgery involving apical support
• Presence of pelvic malignancy
• Active pelvic infection
• Severe comorbidities contraindicating surgery
• Pregnancy

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri University Gazi Yasargil Training and Research Hospital

Diyarbakır, 21000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• abdurrahman sengi, MD

  Saglik Bilimleri University Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; neither participants nor investigators are blinded to the surgical technique performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: "Resident in Obstetrics and Gynecology"

Model Details: Participants will be assigned to one of two groups undergoing either unilateral or bilateral high uterosacral ligament suspension following vaginal hysterectomy.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)