The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03225742
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence; Surgery	Diagnostic Test: to measure the residual volume after catheterization

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery
• 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
urinary catheterization time; one day the patient urinary catheterization after surgery; one day	Diagnostic Test: to measure the residual volume after catheterization; after first micturition to measure the residual volume in bladder
urinary catheterization time; two day the patient urinary catheterization after surgery; two day	Diagnostic Test: to measure the residual volume after catheterization; after first micturition to measure the residual volume in bladder

Outcome Measures

Primary Outcome Measures

1. early postoperative voiding dysfunction and urinary retention [two days]

   after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization)

Secondary Outcome Measures

1. The success of stress urinary incontinence surgery [third month, sixth month and one year]

   third, sixth month and one year after surgery, absence of stress urinary incontinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• stress incontinence

• resistant to medical treatment

Exclusion Criteria:

• had no surgery before

• has no accompanying uterine descensus

• has no neurogenic disorder

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: NCT03225742
• Other Study ID Numbers: 2016/01
• First Posted: Jul 21, 2017
• Last Update Posted: Feb 20, 2020
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress

Study Results

No Results Posted as of Feb 20, 2020