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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Extraperitoneal high sacral ligament suspension surgery
Sacrospinous ligament fixation
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Extraperitoneal high uterosacral ligament suspension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extraperitoneal high sacral ligament suspension Group

Sacrospinous Ligament Suspension Group

Arm Description

We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.

We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them.

Outcomes

Primary Outcome Measures

changes in POP-Q score at different time nodes
Gynecological examination

Secondary Outcome Measures

UDI-6 scores at different time nodes UDI-6
Questionnaires on lower urinary tract symptoms and quality of life
Postoperative urinary incontinence assessment
One hour pad test
OABss score at different time nodes
Questionnaires lower urinary tract symptoms
PFDI-20 score at different time nodes
Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life
ICIQ-SF score at different time nodes
Questionnaires on lower urinary tract symptoms
I-QoL score at different time nodes
Questionnaires on lower urinary tract symptoms and quality of life
PISQ-12 score at different time nodes
Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life
PFIQ-7 score at different time nodes
Questionnaires on pelvic floor function and quality of life

Full Information

First Posted
November 23, 2021
Last Updated
January 8, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05189665
Brief Title
the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Official Title
A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Extraperitoneal high uterosacral ligament suspension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extraperitoneal high sacral ligament suspension Group
Arm Type
Experimental
Arm Description
We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.
Arm Title
Sacrospinous Ligament Suspension Group
Arm Type
Active Comparator
Arm Description
We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them.
Intervention Type
Procedure
Intervention Name(s)
Extraperitoneal high sacral ligament suspension surgery
Intervention Description
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
Intervention Type
Procedure
Intervention Name(s)
Sacrospinous ligament fixation
Intervention Description
The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.
Primary Outcome Measure Information:
Title
changes in POP-Q score at different time nodes
Description
Gynecological examination
Time Frame
pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Secondary Outcome Measure Information:
Title
UDI-6 scores at different time nodes UDI-6
Description
Questionnaires on lower urinary tract symptoms and quality of life
Time Frame
pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Title
Postoperative urinary incontinence assessment
Description
One hour pad test
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
OABss score at different time nodes
Description
Questionnaires lower urinary tract symptoms
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
PFDI-20 score at different time nodes
Description
Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
ICIQ-SF score at different time nodes
Description
Questionnaires on lower urinary tract symptoms
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
I-QoL score at different time nodes
Description
Questionnaires on lower urinary tract symptoms and quality of life
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
PISQ-12 score at different time nodes
Description
Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)
Title
PFIQ-7 score at different time nodes
Description
Questionnaires on pelvic floor function and quality of life
Time Frame
post-operation(at 1month, 3 month, 6 month and a year)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiuli sun, professor
Phone
010-88324354
Email
sunxiuli03351@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiuli sun, professor
Organizational Affiliation
Beijing Key Laboratory of Female Pelvic Floor Disorders
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiuli sun, professor
Phone
010-88324354
Email
sunxiuli03351@126.com
First Name & Middle Initial & Last Name & Degree
jiaoyang song, doctor
Phone
010-88324354
Email
18846453272@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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