Incontinence Surgery and Urodynamics Parameters

NCT ID: NCT04426682

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Incontinence Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

urodynamics parameters

Intervention Type 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.

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.

urodynamics parameters

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pınar Kadirogulları

Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATADEK / 2020.06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value of Urodynamic Evaluation
NCT00803959 COMPLETED PHASE4
Efficacy/Safety of Midurethral Sling
NCT05255289 RECRUITING NA