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

NCT06982157 | Completed DMC

• 1 other identifier: 0111-20-HYMC
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse (POP); Pelvic Organ Prolapse Vaginal Surgery; Hysterectomy

Outcome Measures

Primary Outcomes (2)

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

  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 years

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

  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.

  2 years

Study Arms (2)

Vaginal sacrospinous ligament fixation

Vaginal sacrospinous ligament fixation

laparoscopic uterosacral ligament suspension

laparoscopic uterosacral ligament suspension

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Women who underwent vaginal sacrospinous suspension and laparoscopic uterosacral Sacrospinous ligament fixation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent vaginal sacrospinous suspension and laparoscopic uterosacral Sacrospinous ligament fixation

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 3881000, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonia Alsheik, Dr

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: July 22, 2020
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IL (1)