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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697796
• Other study ID #: PKUPH8
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: December 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Age = 30 years;

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Two different surgical methods
SSLF:sacrospinal ligament fixation EHUS:Extraperitoneal high sacral ligament suspension

Locations

Country	Name	City	State
China	The Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in POP-Q score at different time nodes	Gynecological examination	pre-operation and post-operation(1month, 3 months and 6 months )
Secondary	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 )
Secondary	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 )
Secondary	OABss scores at different time nodes	Questionnaires on lower urinary tract symptoms	pre-operation and post-operation(1month, 3 months and 6 months )