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OpenTrials
Completed

NCT Number: NCT06982157

A Comparison Between Vaginal Sacrospinous Ligament Fixation and Laparoscopic Uterosacral Ligament Suspension as a Uterine Preserving Surgery for Pelvic Organ Prolapse

The investigators present a literature review evaluating the current place of sacrospinous hysteropexy in the surgical management of pelvic organ prolapse. Additionally, to assess the efficacy of the procedure, the investigators performed a meta-analysis comparing sacrospinous hysteropexy with vaginal hysterectomy and repair in terms of anatomical outcomes, complications, and repeat surgery rates.

Vaginal sacrospinous ligament fixation is associated with less anatomic recurrent prolapse and prolapse related symptoms compared with laparoscopic uterosacral ligament suspension in women desiring uterine preservation Hypothesis: Vaginal SSF and lap USLS may have comparable anatomic outcomes in repair of mild to mod uterine prolapse but LUSLS may be associated with longer OT while SSF with more post-op pelvic pain and a higher rate of future prolapse at the ant. Compartment.

Objective: In this study we aim to evaluate the risk of anatomic and symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at a single university-affiliated maternity hospital, by comparing the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery, and therefore establishing personalized approach relying on pre-op parameters.

Specific Aims

* Specific aim 1: Evaluate the efficacy and safety of vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at HY medical center. * Specific aim 2: Compare the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery. * Specific aim 3: Determine the patient characteristics that might delineate which surgery is appropriate for the given group.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Hille Yaffe Medical Center

Hadera, 3881000, Israel

About this study

Vaginal hysterectomy, with or without repair, is the most common procedure performed for apical prolapse. The underlying etiology of apical prolapse is a weakness in the supports of the uterus and upper vagina. There is a growing body of evidence to suggest that uterine preserving procedures for treatment of prolapse are effective and safe. Vaginal sacrospinous hysteropexy is a relatively simple procedure which can be carried out by the generalist gynecologist who performs vaginal repairs.

Sacrospinous hysteropexy is a safe and effective procedure for pelvic organ prolapse and has comparable outcomes to vaginal hysterectomy with repair.

Hysterectomy with laparoscopic uterosacral colpopexy has been shown to produce better objective success rates than laparoscopic uterosacral hysteropexy; however, repeat operation rates are not significantly different.

The surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • From the general Urogynecological cohort who underwent vaginal sacrospinous suspension and laparoscopic uterosacral Sacrospinous ligament fixation at Hillel Yaffe Hospital.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Risks of anatomic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension

    Time frame: 2 years

    Evaluate the risk of anatomic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair.

    The evaluation will be carried out by comparing the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery, and therefore establishing personalized approach relying on pre-op parameters.

  2. Risks of symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension

    Time frame: 2 years

    Evaluate the risk of symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair. The evaluation will be carried out by comparing the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery, and therefore establishing personalized approach relying on pre-op parameters.

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Acronym: POP-Q USS USLS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 21, 2025
Registry last updated
Nov 18, 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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