Incontinence Surgery and Urodynamics Parameters

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426682
• Other study ID #: ATADEK / 2020.06
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Incontinence
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	urodynamics parameters bladder complians	urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians	5 YEARS
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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