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NCT03221725 Clinical Trial

The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03221725
Other study ID # 2016/02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date February 1, 2018

Study information
Verified date January 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgery for Stage II-III Pelvic organ prolapse

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 1, 2018
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• sacrospinous ligament fixation
sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse

Locations
Country Name City State
Turkey Kerem Doga Seckin Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary development of stress urinary incontinence in one year
Secondary postoperative vaginal length in one year
See also
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A