the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189665
• Other study ID #: Pkuh4
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: April 2023

Study information

• Verified date: October 2021
• Source: Peking University People's Hospital
• Contact: xiuli sun, professor
• Phone: 010-88324354
• Email: sunxiuli03351[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.

Description:

Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age =30 years old;

pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life

Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery

The patient agrees to conduct the study and can be followed up on time.

Exclusion Criteria:

Those who cannot tolerate surgery and anesthesia

Those who need to remove the uterus

Those who have removed the uterus

Those who cannot be followed up on time.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Extraperitoneal high sacral ligament suspension surgery
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
• Sacrospinous ligament fixation
The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.

Locations

Country	Name	City	State
China	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(at 1month, 3 month, 6 month and a year)
Secondary	UDI-6 scores at different time nodes UDI-6	Questionnaires on lower urinary tract symptoms and quality of life	pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Secondary	Postoperative urinary incontinence assessment	One hour pad test	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	OABss score at different time nodes	Questionnaires lower urinary tract symptoms	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	PFDI-20 score at different time nodes	Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	ICIQ-SF score at different time nodes	Questionnaires on lower urinary tract symptoms	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	I-QoL score at different time nodes	Questionnaires on lower urinary tract symptoms and quality of life	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	PISQ-12 score at different time nodes	Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life	post-operation(at 1month, 3 month, 6 month and a year)
Secondary	PFIQ-7 score at different time nodes	Questionnaires on pelvic floor function and quality of life	post-operation(at 1month, 3 month, 6 month and a year)