Effect of Sling Insertion Angle on Surgical Outcomes and Quality of Life Following Single-Incision Midurethral Sling Surgery for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Objective cure rate at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Standard-angle sling group (≈45°)
Participants undergoing single-incision midurethral sling surgery with a standard sling insertion angle of approximately 45 degrees toward the obturator foramen. This represents the conventional transobturator-oriented trajectory used in routine clinical practice.
Acute-angle sling group (<45°)
Participants undergoing single-incision midurethral sling surgery with a sling insertion angle of less than 45 degrees, corresponding to a retropubic, TVT-like trajectory. This approach is hypothesized to provide earlier urethral support and improved early continence outcomes.
结局指标
主要结局
Objective cure rate at 6 months
时间窗: 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.
次要结局
- Objective cure rate at 1 and 3 months(1 month and 3 months)
- Postoperative voiding difficulty(Within 6 months after surgery)
- Persistent stress urinary incontinence symptoms(Up to 6 months)
- Quality of life measured by I-QOL score(6 months)
研究者
Yu, wan-ru
MD, Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital
Shin Kong Wu Ho-Su Memorial Hospital