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

January 8, 2022 updated by: Sun Xiuli, Peking University People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extraperitoneal high sacral ligament suspension Group
We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.
Procedure: Extraperitoneal high sacral ligament suspension surgery
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
Active Comparator: Sacrospinous Ligament Suspension Group
We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UDI-6 scores at different time nodes UDI-6
Time Frame: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Questionnaires on lower urinary tract symptoms and quality of life
pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Postoperative urinary incontinence assessment
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
One hour pad test
post-operation(at 1month, 3 month, 6 month and a year)
OABss score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
Questionnaires lower urinary tract symptoms
post-operation(at 1month, 3 month, 6 month and a year)
PFDI-20 score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
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)
ICIQ-SF score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
Questionnaires on lower urinary tract symptoms
post-operation(at 1month, 3 month, 6 month and a year)
I-QoL score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
Questionnaires on lower urinary tract symptoms and quality of life
post-operation(at 1month, 3 month, 6 month and a year)
PISQ-12 score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
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)
PFIQ-7 score at different time nodes
Time Frame: post-operation(at 1month, 3 month, 6 month and a year)
Questionnaires on pelvic floor function and quality of life
post-operation(at 1month, 3 month, 6 month and a year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: xiuli sun, professor, Beijing Key Laboratory of Female Pelvic Floor Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

January 8, 2022

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pkuh4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Extraperitoneal high uterosacral ligament sling is effective in treating pelvic organ prolapse, and postoperative anatomical recovery is good, not inferior to traditional sacral ligament sling

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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