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

February 18, 2020 updated by: Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Kerem Doga Seckin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

the women who have stress incontinence at physical examination and urodynamics tests

Description

Inclusion Criteria:

  • stress incontinence
  • resistant to medical treatment

Exclusion Criteria:

  • had no surgery before
  • has no accompanying uterine descensus
  • has no neurogenic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early postoperative voiding dysfunction and urinary retention
Time Frame: two days
after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization)
two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success of stress urinary incontinence surgery
Time Frame: third month, sixth month and one year
third, sixth month and one year after surgery, absence of stress urinary incontinence
third month, sixth month and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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