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Completed

NCT Number: NCT04426682

Incontinence Surgery and Urodynamics Parameters

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.

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Key information

Conditions

Incontinence Surgery

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. urodynamics parameters V max

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3

  2. urodynamics parameters bladder complians

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians

  3. urodynamics parameters valsalva leak point pressure

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)

  4. urodynamics parameters abdominal leak point pressure

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)

  5. urodynamics parameters P det

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)

  6. urodynamics parameters P abd

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)

  7. urodynamics parameters P urethral

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)

  8. urodynamics parameters UPP

    Time frame: 5 YEARS

    urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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