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OpenTrials
Completed

NCT Number: NCT03831217

Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

Primary location

Kaan Baydemir

Ankara, Çankaya, Turkey (Türkiye)

About this study

Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.

Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Who can participate

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

Inclusion criteria

  • Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
  • Patients come to follow up

Exclusion criteria

  • inability in verbal and written communication
  • impairment in cognitive functions

Treatment and study plan

mid urethral sling surgery

Procedure

patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.

Primary outcomes

  1. Objective cure rates

    Time frame: 1-11 years

    Objective cure is negative cough stress test.

  2. Subjective cure rates

    Time frame: 1-11 years

    Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.

Secondary outcomes

  1. Tape localization

    Time frame: 1-11 years

    Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated

  2. Quality of life(QoL) after surgery

    Time frame: 1-11 years

    Impact of surgery on quality of life will be evaluated by QoL questionnaire

  3. Patient satisfaction

    Time frame: 1-11 years

    Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2019
Registry last updated
Apr 26, 2023

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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