Comparison of Post-operative Symptoms After Two Surgeries for Patients With Pelvic Organ Prolapse

Comparison of Post-operative Lower Urinary Tract Symptoms After Sacrospinous Ligament Fixation or Extraperitoneal High Uterosacral Ligament Suspension for Patients With Pelvic Organ Prolapse

Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Two different surgical methods

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • The Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

patients had pelvic organ prolapse receiving two specific surgical methods

Description

Inclusion Criteria:

• Age ≥ 30 years;

  • Because pelvic organ prolapse in our hospital, we performed extraperitoneal high sacral ligament suspension or sacrospinal ligament fixation; ③ Those who have no surgical contraindication and can tolerate surgery and anesthesia.

Exclusion Criteria:

• Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation	Procedure: Two different surgical methods; SSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension
patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension	Procedure: Two different surgical methods; SSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in POP-Q score at different time nodes	Gynecological examination	pre-operation and post-operation(1month, 3 months and 6 months )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-6 scores at different time nodes	Questionnaires on lower urinary tract symptoms and quality of life	pre-operation and post-operation(1month, 3 months and 6 months )
PFDI-20 scores at different time nodes	Questionnaires on lower urinary tract symptoms and quality of life	pre-operation and post-operation(1month, 3 months and 6 months )
OABss scores at different time nodes	Questionnaires on lower urinary tract symptoms	pre-operation and post-operation(1month, 3 months and 6 months )

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PKUPH8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No