The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03221725
Collaborator
(none)
100
1
1
12
8.3
Study Details
Study Description
Brief Summary
Surgery for Stage II-III Pelvic organ prolapse
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 1, 2017
Actual Primary Completion Date
:
Aug 1, 2017
Actual Study Completion Date
:
Feb 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sacrospinosus fixation group The group which sacrospinous fixation was performed |
Procedure: sacrospinous ligament fixation
sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse
|
Outcome Measures
Primary Outcome Measures
- development of stress urinary incontinence [in one year]
Secondary Outcome Measures
- postoperative vaginal length [in one year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kerem Doga Seckin | İstanbul | Turkey |
Sponsors and Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kerem Doga Seckin,
ass prof,
Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03221725
Other Study ID Numbers:
- 2016/02
First Posted:
Jul 19, 2017
Last Update Posted:
Jan 30, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kerem Doga Seckin,
ass prof,
Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms: