Female Stress Urinary Incontinence, Stress Urinary Incontinence (SUI)
Conditions
Keywords
Single-incision midurethral sling, Sling insertion angle, Stress urinary incontinence, I-QOL, Objective cure, Voiding dysfunction
Brief summary
This study aims to evaluate the effect of sling insertion angle on surgical outcomes and quality of life in women with stress urinary incontinence (SUI) undergoing single-incision midurethral sling surgery. Women diagnosed with urodynamic stress urinary incontinence who underwent surgery using a single-incision sling system were included. Patients were categorized into two groups based on sling insertion angle: an acute-angle group (\<45°, resembling a retropubic trajectory) and a standard-angle group (approximately 45°, toward the obturator foramen). The primary outcome was objective cure at 6 months, defined as a negative cough stress test without the need for additional anti-incontinence treatment. Secondary outcomes included objective cure at 1 and 3 months, postoperative voiding difficulty, persistent SUI symptoms, and quality of life assessed using the Incontinence Quality of Life (I-QOL) questionnaire. This study provides clinical evidence on whether sling insertion angle influences early and mid-term outcomes following single-incision midurethral sling surgery.
Detailed description
This prospective cohort study was conducted at a tertiary medical center and included women with urodynamic stress urinary incontinence (SUI) who underwent single-incision midurethral sling surgery between October 2017 and October 2019. All procedures were performed by a single experienced surgeon using a standardized surgical technique with the same sling system. Patients were classified into two groups according to sling insertion angle: the acute-angle group (\<45°), representing a trajectory similar to the retropubic approach, and the standard-angle group (approximately 45°), directed toward the obturator foramen. The sling angle was assessed intraoperatively based on the orientation of the insertion instrument. Inclusion criteria included women with confirmed urodynamic stress incontinence and a preoperative 1-hour pad test result greater than 10 grams. Exclusion criteria included detrusor overactivity, mixed urinary incontinence, prior pelvic surgery, voiding dysfunction, neurological disease, and pelvic organ prolapse stage III or higher. The primary outcome was objective cure at 6 months postoperatively, defined as a negative cough stress test and no requirement for additional anti-incontinence treatment. Secondary outcomes included objective cure rates at 1 and 3 months, postoperative voiding difficulty, persistent SUI symptoms, and quality of life assessed using the validated Incontinence Quality of Life (I-QOL) questionnaire. Postoperative follow-up evaluations were conducted at 1, 3, and 6 months. Clinical outcomes and complications were systematically recorded and analyzed to determine whether sling insertion angle affects surgical efficacy and patient-reported outcomes. The study was approved by the Institutional Review Board of Shin Kong Wu Ho-Su Memorial Hospital, and all procedures were conducted in accordance with the Declaration of Helsinki.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Female patients aged 18 years or older * Diagnosis of urodynamic stress urinary incontinence (SUI) * Preoperative 1-hour pad test \>10 g * Undergoing single-incision midurethral sling surgery (ContaSure Needleless system) * Availability of complete clinical and follow-up data for at least 6 months
Exclusion criteria
* Presence of detrusor overactivity on urodynamic study * Mixed urinary incontinence with predominant urge symptoms * Voiding dysfunction * History of prior pelvic or anti-incontinence surgery * Neurological disorders affecting lower urinary tract function * Pelvic organ prolapse stage ≥ III (POP-Q classification)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective cure rate at 6 months | 6 months after surgery | Objective cure is defined as a negative cough stress test and no requirement for additional anti-incontinence treatment at 6 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective cure rate at 1 and 3 months | 1 month and 3 months | Objective cure defined as a negative cough stress test without need for additional treatment at 1 and 3 months postoperatively. |
| Postoperative voiding difficulty | Within 6 months after surgery | Incidence of postoperative voiding difficulty requiring catheterization or clinical intervention. |
| Persistent stress urinary incontinence symptoms | Up to 6 months | Presence of persistent subjective stress urinary incontinence symptoms reported by patients after surgery. |
| Quality of life measured by I-QOL score | 6 months | Quality of life assessed using the Incontinence Quality of Life (I-QOL) questionnaire, with scores ranging from 0 to 100, where higher scores indicate better quality of life. |
Countries
Taiwan