Incontinence Surgery and Urodynamics Parameters

Completed

• Conditions: Surgery; Incontinence

• Registration Number: NCT04426682
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-01-01
• Status Verified: 2020-06
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urodynamics parameters V max	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	5 YEARS	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
urodynamics parameters P abd	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	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	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	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	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	5 YEARS	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey