Back to resultsThe Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sacrospinous ligament fixation
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring sacrospinous ligament fixation, stress urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Pelvic organ prolapse stage II-III
- has no incontinence before surgery
Exclusion Criteria:
- had surgery before
- Pelvic organ prolapse stage I or IV
Sites / Locations
- Kerem Doga Seckin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sacrospinosus fixation group
Arm Description
The group which sacrospinous fixation was performed
Outcomes
Primary Outcome Measures
development of stress urinary incontinence
Secondary Outcome Measures
postoperative vaginal length
Full Information
NCT ID
NCT03221725
First Posted
July 14, 2017
Last Updated
January 27, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03221725
Brief Title
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
Official Title
The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research 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
Surgery for Stage II-III Pelvic organ prolapse
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
sacrospinous ligament fixation, stress urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sacrospinosus fixation group
Arm Type
Experimental
Arm Description
The group which sacrospinous fixation was performed
Intervention Type
Procedure
Intervention Name(s)
sacrospinous ligament fixation
Intervention Description
sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse
Primary Outcome Measure Information:
Title
development of stress urinary incontinence
Time Frame
in one year
Secondary Outcome Measure Information:
Title
postoperative vaginal length
Time Frame
in one year
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pelvic organ prolapse stage II-III
has no incontinence before surgery
Exclusion Criteria:
had surgery before
Pelvic organ prolapse stage I or IV
Facility Information:
Facility Name
Kerem Doga Seckin
City
İstanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
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