Clinical trial NCT04426682: Incontinence Surgery and Urodynamics Parameters
Official title: In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Surgery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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. .

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.


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

Primary outcomes:
measure: urodynamics parameters V max
timeFrame: 5 YEARS
measure: urodynamics parameters bladder complians
timeFrame: 5 YEARS
measure: urodynamics parameters valsalva leak point pressure
timeFrame: 5 YEARS
measure: urodynamics parameters abdominal leak point pressure
timeFrame: 5 YEARS
measure: urodynamics parameters P det
timeFrame: 5 YEARS
measure: urodynamics parameters P abd
timeFrame: 5 YEARS
measure: urodynamics parameters P urethral
timeFrame: 5 YEARS
measure: urodynamics parameters UPP
timeFrame: 5 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: