Incontinence Surgery and Urodynamics Parameters

NCT04426682 | Completed

• 1 other identifier: ATADEK / 2020.06
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence; Surgery

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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

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

Interventions

urodynamics parameters DIAGNOSTIC_TEST

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.

post-operative urinary incontinents; without postoperative urinary incontinence

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. .

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

TU (1)