Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Objective Cure Rate Based on Negative Stress Test
研究概览
简要总结
This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.
详细描述
This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).
The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.
Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.
Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor evaluating postoperative results is blinded to group allocation.
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
- •Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
- •Positive stress test (urine leakage on coughing with a comfortably full bladder)
- •Q-tip test showing urethral hypermobility (>30 degrees)
- •Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
- •Eligible for transobturator tape (TOT) surgery
- •Body mass index (BMI) less than 35 kg/m²
- •Able to provide informed consent and follow postoperative instructions
排除标准
- •History of prior midurethral sling surgery
- •Mixed urinary incontinence or urge-dominant symptoms
- •Pelvic organ prolapse stage > II according to the POP-Q system
- •Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
- •Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
- •Pregnant or planning to become pregnant within the next 12 months
- •Severe comorbid conditions (e.g., uncontrolled diabetes mellitus, active malignancy, pelvic radiotherapy)
- •Use of medications that significantly affect bladder function (e.g., anticholinergics, diuretics)
- •Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
研究组 & 干预措施
1.2 cm Mesh (Intervention Group)
Participants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh.
干预措施: 1.2 cm Mesh TOT (Device)
1.0 cm Mesh (Control Group)
Participants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure.
干预措施: 1.0 cm Mesh TOT (Device)
结局指标
主要结局
Objective Cure Rate Based on Negative Stress Test
时间窗: 6 months postoperatively
Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.
次要结局
- Change in ICIQ-SF Score(6 months postoperatively)
- Incidence of Mesh-Related Complications(6 months postoperatively)
- Recurrence of Stress Urinary Incontinence(6 months postoperatively)
- Patient Satisfaction Score(6 months postoperatively)
研究者
Izzet Celegen
Assistant professor
Yuzuncu Yıl University