Skip to main content
Clinical Trials/NCT04426682
NCT04426682
Completed
Not Applicable

In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country210 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incontinence
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
210
Locations
1
Primary Endpoint
urodynamics parameters V max
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Urodynamic evaluation is important before stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and to determine the factors that may affect the effectiveness of surgery and the possibility of complications. Urodynamics evaluation is performed in the preoperative period in patients scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied with post-operative recurrence due to surgery failure or different reasons.

It is aimed to show whether there is a difference between the urodynamics parameters of these patients who were examined preoperatively and the urodynamics parameters examined in case of postoperative failure. Thus, the primary goal; to show which of these parameters has deterioration or if the surgical method is insufficient if it is within certain limits or urinary incontinence may recur.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
June 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pınar Kadirogulları

Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients who have previously undergone surgery for stress incontinence
  • Those who are symptomatic again in their post-operative follow-up (urinary incontinence),
  • Patients who underwent preoperative and postoperative urodynamics

Exclusion Criteria

  • Those with chronic diseases or medications that may cause urinary incontinence
  • Patients with mixed or urge incontinence
  • Patients who are not symptomatic postoperatively

Outcomes

Primary Outcomes

urodynamics parameters V max

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3

urodynamics parameters bladder complians

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians

urodynamics parameters P abd

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)

urodynamics parameters P urethral

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)

urodynamics parameters valsalva leak point pressure

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)

urodynamics parameters UPP

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)

urodynamics parameters abdominal leak point pressure

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)

urodynamics parameters P det

Time Frame: 5 YEARS

urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)

Study Sites (1)

Loading locations...

Similar Trials