Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189665
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Xiuli, Peking University People's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Extraperitoneal high sacral ligament suspension surgery Procedure: Sacrospinous ligament fixation Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Postoperative urinary incontinence assessment [ Time Frame: post-operation(at 1month, 3 month, 6 month and a year) ]
    One hour pad test

  3. OABss score at different time nodes [ Time Frame: post-operation(at 1month, 3 month, 6 month and a year) ]
    Questionnaires lower urinary tract symptoms

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189665


Contacts
Layout table for location contacts
Contact: xiuli sun, professor 010-88324354 sunxiuli03351@126.com

Locations
Layout table for location information
China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: xiuli sun, professor    010-88324354    sunxiuli03351@126.com   
Contact: jiaoyang song, doctor    010-88324354    18846453272@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Layout table for investigator information
Study Chair: xiuli sun, professor Beijing Key Laboratory of Female Pelvic Floor Disorders
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sun Xiuli, Chief Gynecology Physician, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05189665    
Other Study ID Numbers: Pkuh4
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 2 years

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Xiuli, Peking University People's Hospital:
Extraperitoneal high uterosacral ligament suspension
Additional relevant MeSH terms:
Layout table for MeSH terms
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical