Back to resultsthe Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
Primary Purpose
Pelvic Organ Prolapse
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
transvaginal synthetic mesh
Tolterodine
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The patients with POP who have not undergone surgery are excluded.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
No Intervention
No Intervention
Other
Arm Label
the efficacy
the recurrence rate
the quality of life
the rate of the LUTS
Arm Description
transvaginal synthetic mesh
transvaginal synthetic mesh
transvaginal synthetic mesh
We use Tolterodine to improve patients' LUTS
Outcomes
Primary Outcome Measures
the objective recurrent rate
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
Secondary Outcome Measures
the rate of the lower urinary tract symptoms
We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence.
the quality of life questionnaires
The QOL questionnaires include PFDI-20 and PFIQ-7.
Full Information
NCT ID
NCT02599311
First Posted
November 1, 2015
Last Updated
May 21, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02599311
Brief Title
the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
Official Title
The Clinical Efficacy of Pelvic Organ Prolapse Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the efficacy
Arm Type
Other
Arm Description
transvaginal synthetic mesh
Arm Title
the recurrence rate
Arm Type
No Intervention
Arm Description
transvaginal synthetic mesh
Arm Title
the quality of life
Arm Type
No Intervention
Arm Description
transvaginal synthetic mesh
Arm Title
the rate of the LUTS
Arm Type
Other
Arm Description
We use Tolterodine to improve patients' LUTS
Intervention Type
Device
Intervention Name(s)
transvaginal synthetic mesh
Intervention Description
transvaginal synthetic mesh
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Other Intervention Name(s)
Tolterodine tartrate
Intervention Description
Tolterodine tartrate can improve patients' LUTS.
Primary Outcome Measure Information:
Title
the objective recurrent rate
Description
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
Time Frame
one year after surgery
Secondary Outcome Measure Information:
Title
the rate of the lower urinary tract symptoms
Description
We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence.
Time Frame
one year after surgery
Title
the quality of life questionnaires
Description
The QOL questionnaires include PFDI-20 and PFIQ-7.
Time Frame
one year after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
The patients with POP who have not undergone surgery are excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Sun, professor
Phone
861088324354
Email
zzucaotingting@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianliu Wang, professor
Organizational Affiliation
department of Gynecology, Peking University People's Hospital
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
Tingting Cao, resident
Phone
861088324354
Email
sxlctt2015@126.com
12. IPD Sharing Statement
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the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
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