NCT05189665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 12, 2022

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

November 23, 2021

Last Update Submit

January 8, 2022

Conditions

Pelvic Organ Prolapse

Keywords

Extraperitoneal high uterosacral ligament suspension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • UDI-6 scores at different time nodes UDI-6

    pre-operation and post-operation(at 1month, 3 month, 6 month and a year)

  • Postoperative urinary incontinence assessment

    post-operation(at 1month, 3 month, 6 month and a year)

  • OABss score at different time nodes

    post-operation(at 1month, 3 month, 6 month and a year)

  • PFDI-20 score at different time nodes

    post-operation(at 1month, 3 month, 6 month and a year)

  • ICIQ-SF score at different time nodes

    post-operation(at 1month, 3 month, 6 month and a year)

  • +3 more secondary outcomes

Study Arms (2)

Extraperitoneal high sacral ligament suspension Group

EXPERIMENTAL

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

Procedure: Extraperitoneal high sacral ligament suspension surgery

Sacrospinous Ligament Suspension Group

ACTIVE COMPARATOR

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

Procedure: Sacrospinous ligament fixation

Interventions

Extraperitoneal high sacral ligament suspension surgeryPROCEDURE

The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .

Extraperitoneal high sacral ligament suspension Group
Sacrospinous ligament fixationPROCEDURE

The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.

Sacrospinous Ligament Suspension Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • xiuli sun, professor

    Beijing Key Laboratory of Female Pelvic Floor Disorders

    STUDY CHAIR

Central Study Contacts

xiuli sun, professor

CONTACT

010-88324354sunxiuli03351@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Gynecology Physician

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 12, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

April 1, 2023

Last Updated

January 12, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
2 years

Locations

CN(1)