Pelvic Floor Disorders, Stress Urinary Incontinence in Women
Conditions
Keywords
sui, tpus
Brief summary
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques. The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated. The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
Interventions
PROCEDURETransobturator Tape (TOT) Procedure
Placement of a synthetic tape beneath the mid-urethra via the transobturator route.
PROCEDURETension-Free Vaginal Tape (TVT) Procedure
Placement of a synthetic tape beneath the mid-urethra using a retropubic approach.
PROCEDUREBurch Colposuspension Procedure
Suspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures.
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants were assigned to one of three parallel intervention groups (TOT, TVT, or Burch colposuspension), and each participant received only one type of surgical intervention. Outcomes were assessed and compared between groups during the same follow-up period.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older * Diagnosis of stress urinary incontinence based on clinical evaluation * Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension * Ability to provide written informed consent * Willingness to participate in the study and comply with follow-up visits
Exclusion criteria
* Mixed or urge-predominant urinary incontinence * Previous anti-incontinence or pelvic floor surgery * Neurogenic bladder disorders * Active urinary tract infection at the time of evaluation * Pregnancy or planned pregnancy during the study period * Known pelvic malignancy * Inability to undergo transperineal ultrasonographic evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound | Baseline (preoperative) and 3 months postoperatively | The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Improvement in Stress Urinary Incontinence Symptoms | Baseline and 3 months postoperatively | Subjective outcomes were assessed using the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). For both scales, scores range from 0 to 100, where higher scores indicate a greater impact of symptoms and worse quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Anatomical Outcomes Between Surgical Techniques | 3 months postoperatively | Anatomical outcomes assessed by transperineal ultrasonography were compared between the TOT, TVT, and Burch colposuspension groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed