Incontinence Surgery and Urodynamics Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Incontinence
• Intervention / Treatment: Diagnostic test: urodynamics parameters

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 33404
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The files of the patients will be accessed through the system, and patients who have had incontinence surgery and applied again due to recurrence will be selected. The data of these patients will be scanned and recorded. The control group will also be created in the same way, and data of patients who have undergone surgery and have no urinary incontinence and who have postoperative urodynamics will be recorded. .

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-operative urinary incontinents; In patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence. The first group will consist of postoperative urinary incontinence recurrent patients. Patients whose urodynamics are reperformed due to recurrence are the study group.	Diagnostic test: urodynamics parameters; Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence. Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons. It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure.
without postoperative urinary incontinence; Patients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group.	Diagnostic test: urodynamics parameters; Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence. Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons. It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urodynamics parameters V max	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3	5 YEARS
urodynamics parameters bladder complians	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians	5 YEARS
urodynamics parameters valsalva leak point pressure	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)	5 YEARS
urodynamics parameters abdominal leak point pressure	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)	5 YEARS
urodynamics parameters P det	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)	5 YEARS
urodynamics parameters P abd	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)	5 YEARS
urodynamics parameters P urethral	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)	5 YEARS
urodynamics parameters UPP	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)	5 YEARS

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ATADEK / 2020.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No