NCT03225742

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 20, 2020

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

July 14, 2017

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The success of stress urinary incontinence surgery

    third month, sixth month and one year

Study Arms (2)

urinary catheterization time; one day

the patient urinary catheterization after surgery; one day

Diagnostic Test: to measure the residual volume after catheterization

urinary catheterization time; two day

the patient urinary catheterization after surgery; two day

Diagnostic Test: to measure the residual volume after catheterization

Interventions

after first micturition to measure the residual volume in bladder

urinary catheterization time; one dayurinary catheterization time; two day

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • stress incontinence
  • resistant to medical treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerem Doga Seckin

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass prof

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 21, 2017

Study Start

February 1, 2017

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

February 20, 2020

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations