CClinicalTrials.gg
CompletedNCT03831217Updated Apr 26, 2023

Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

An observational study in Stress Urinary Incontinence, sponsored by Ankara University. Completed at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by Ankara University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Stress Urinary Incontinence

Keywords

  • Trans-Obturator Tape
  • Tension-Free Vaginal Tape
  • Mid-Urethral Sling surgeries
  • Stress Urinary Incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 58 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology Department since 2007 at any age.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • inability in verbal and written communication
  • impairment in cognitive functions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No

Interventions

  • Proceduremid urethral sling surgery

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

06

What researchers measure

Primary outcomes

  1. Objective cure rates

    Objective cure is negative cough stress test.

    Time frame: 1-11 years

  2. Subjective cure rates

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

    Time frame: 1-11 years

Secondary outcomes

  1. Tape localization

    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

    Time frame: 1-11 years

  2. Quality of life(QoL) after surgery

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

    Time frame: 1-11 years

  3. Patient satisfaction

    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.

    Time frame: 1-11 years

07

Study locations

1 site
  • Kaan Baydemir
    Ankara, Çankaya, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03831217
Lead sponsor
Ankara University
Responsible party
kaan baydemir (kaan baydemir md, Ankara University) — Principal investigator
First posted
Feb 5, 2019
Start date
Oct 15, 2019
Primary completion
Jun 1, 2020
Completion
Jun 15, 2020
Last update
Apr 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion