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

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05697796
Collaborator
(none)
2
1
1.7
1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Two different surgical methods

Study Design

Study Type:
Observational
Actual Enrollment :
2 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Post-operative Lower Urinary Tract Symptoms After Sacrospinous Ligament Fixation or Extraperitoneal High Uterosacral Ligament Suspension for Patients With Pelvic Organ Prolapse
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Dec 23, 2022
Actual Study Completion Date :
Dec 23, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. changes in POP-Q score at different time nodes [pre-operation and post-operation(1month, 3 months and 6 months )]

    Gynecological examination

Secondary Outcome Measures

  1. UDI-6 scores at different time nodes [pre-operation and post-operation(1month, 3 months and 6 months )]

    Questionnaires on lower urinary tract symptoms and quality of life

  2. PFDI-20 scores at different time nodes [pre-operation and post-operation(1month, 3 months and 6 months )]

    Questionnaires on lower urinary tract symptoms and quality of life

  3. OABss scores at different time nodes [pre-operation and post-operation(1month, 3 months and 6 months )]

    Questionnaires on lower urinary tract symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Peking University People's Hospital Beijing Beijing China 100044

Sponsors and Collaborators

  • Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Xiuli, Department director, professor, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT05697796
Other Study ID Numbers:
  • PKUPH8
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023