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

Surgery Clinical Trial

Official title:

The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225742
• Other study ID #: 2016/01
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• stress incontinence

• resistant to medical treatment

Exclusion Criteria:

• had no surgery before

• has no accompanying uterine descensus

• has no neurogenic disorder

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Surgery
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Diagnostic Test:
• to measure the residual volume after catheterization
after first micturition to measure the residual volume in bladder

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	early postoperative voiding dysfunction and urinary retention	after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization)	two days
Secondary	The success of stress urinary incontinence surgery	third, sixth month and one year after surgery, absence of stress urinary incontinence	third month, sixth month and one year