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NCT Number: NCT07552337

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri University Gazi Yasargil Training and Research Hospital

Diyarbakır, 21000, Turkey (Türkiye)

About this study

Pelvic organ prolapse is a common condition affecting women, often requiring surgical intervention. Vaginal hysterectomy combined with high uterosacral ligament suspension is a widely used technique for apical support. However, there is ongoing debate regarding whether unilateral or bilateral suspension provides better anatomical and clinical outcomes.

This study is designed as a comparative clinical study evaluating unilateral versus bilateral high uterosacral ligament suspension performed following vaginal hysterectomy. Patients undergoing surgery for pelvic organ prolapse will be included and assigned to one of the two surgical approaches according to the study design.

The primary objective is to compare anatomical success rates between the two techniques. Secondary outcomes include perioperative complications, recurrence rates, and postoperative functional outcomes.

The findings of this study are expected to provide evidence regarding the optimal surgical approach for uterosacral ligament suspension and contribute to improving patient outcomes in pelvic organ prolapse surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Anatomical Success Rate

    Time frame: 12 months postoperatively

    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.

Secondary outcomes

  1. Prolapse Recurrence Rate

    Time frame: 12 months postoperatively

    Recurrence of pelvic organ prolapse defined as descent of any vaginal compartment to or beyond the hymen during follow-up.

  2. Operative Time

    Time frame: Intraoperative

    Duration of surgery measured from incision to completion of the procedure.

  3. Intraoperative Complications

    Time frame: During surgery

    Occurrence of complications during surgery, including bleeding, ureteral injury, or other surgical complications.

  4. Postoperative Complications

    Time frame: Up to 30 days postoperatively

    Complications occurring after surgery, including infection, pain, or need for reoperation.

  5. Functional Outcomes

    Time frame: 6 and 12 months postoperatively

    Patient-reported outcomes including urinary, bowel, and sexual function assessed using validated questionnaires.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Acronym: HUSLS

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

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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