the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
The Clinical Efficacy of Pelvic Organ Prolapse Surgery
1 other identifier
interventional
1,000
1 country
1
Brief Summary
One thousand patients with stage\>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMay 23, 2017
May 1, 2017
4.2 years
November 1, 2015
May 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the objective recurrent rate
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
one year after surgery
Secondary Outcomes (2)
the rate of the lower urinary tract symptoms
one year after surgery
the quality of life questionnaires
one year after surgery
Study Arms (4)
the efficacy
OTHERtransvaginal synthetic mesh
the recurrence rate
NO INTERVENTIONtransvaginal synthetic mesh
the quality of life
NO INTERVENTIONtransvaginal synthetic mesh
the rate of the LUTS
OTHERWe use Tolterodine to improve patients' LUTS
Interventions
Tolterodine tartrate can improve patients' LUTS.
Eligibility Criteria
You may qualify if:
- The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.
You may not qualify if:
- The patients with POP who have not undergone surgery are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianliu Wang, professor
department of Gynecology, Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2015
First Posted
November 6, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
May 23, 2017
Record last verified: 2017-05