TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Complications of the treatment
研究概览
简要总结
One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary incontinence is physical activity-related stress urinary incontinence (SUI). If the first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment options are suburethral sling operation or transurethral bulking injection. Randomized studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient satisfaction is missing.
This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI. Main outcome measures are patient satisfaction, complications and effectiveness of the treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness, pain during and after treatment and changes in Quality of Life and symptoms.
详细描述
- Background
One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary incontinence is physical activity-related stress urinary incontinence (SUI). If the first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment options are suburethral sling operation or transurethral bulking injection.
Tension-free Vaginal Tape (TVT) is considered the gold standard for the treatment of SUI1. TVT operation is an effective treatment with efficacy as high as 90%. TVT performed by an experienced operator carries a very low risk of serious complications. Following complications rates have been reported after TVT: bladder perforation 3,8%, urinary tract infection 4,1%, complications requiring laparotomy 3,4%, complete postoperative urinary retention 2,3% and minor voiding difficulties 7,6%. All these complications or side effects occur in up to 20 - 30% of the patients. Long-term effects of TVT are still unclear and complications such as vaginal erosion or urinary tract protrusion of the tape are concerning.
Bulking agents create an artificial mass into the urethral submucosa and according to hypothesis improve urethral coaptation and restore continence especially when abdominal pressure is increased. It has also been suggested that midurethral injection therapy may increase the central filler volume and consequently increase the power of the urethral sphincter. Several different agents have been used for periurethral and transurethral injections, e.g. collagen, ethylene vinyl alcohol, hyaluronic acid and polyacrylamide hydrogel (PAHG). However, some of these agents have been abandoned due to safety issues.
In Nordic countries Polyacrylamide hydrogel (PAHG) is nowadays used for urethral injections. PAHG is biocompatible, non-biodegradable, non-allergenic, non-migrational, atoxic, stable, and sterile. Urethral bulking therapy is minimally invasive in nature and treatment doesn't require hospitalization. Procedure can be performed under local anaesthesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No previous stress urinary incontinence operation
- •Positive cough stress test without urge-type urine leakage
- •Post-void residual urine volume (PVR) <100ml
- •Urine bladder capacity >3dl in 3-day micturition diary.
排除标准
- •BMI >35 kg/m2
- •Neurogenic disease which can be associated with bladder disorders
- •Use of anticholinergics or mirabegrone
- •Illness or condition causing even a relative risk for complications in TVT operation (e.g. lower urinary tract anomaly, previous radiation therapy of the pelvis, anticoagulation or haemophilia)
- •Active malignancy
- •Current UTI or recurrent UTI (over 3 episodes within the past year)
- •Urogenital prolapse of more than second degree
- •Pregnancy or future plans of pregnancy
- •Inability to understand purpose of the study
- •Uterine myoma requiring operational treatment
- •Autoimmune or connective tissue disease contraindicating operation
研究组 & 干预措施
Tension-free Vaginal Tape
干预措施: Tension-free Vaginal Tape (Device)
结局指标
主要结局
Complications of the treatment
时间窗: Up to 5 years after treatment
Possible complications are listed after treatment and on follow-up visits.
Effectiveness of the treatment in reducing urinary leakage
时间窗: Up to 5 years after treatment
A stress pad test (Pad weighing after 20 jumping jacks on the spot and three forceful coughs in the standing position with 300 ml bladder volume. To women unable to perform the test it was modified version to 10 coughs in the standing position) performed before treatment and on follow-up visits (3 months, 1 year, 3 years, 5 years).
Patient satisfaction to treatment
时间窗: Up to 5 years after treatment
Patient satisfaction measured on VAS scale of 0 (extremely unsatisfied) to 100 (extremely satisfied). VAS ≥80 was defined as a good level of satisfaction. Patient satisfaction is measured on follow-up visits (3 months, 1 year, 3 years, 5 years).
次要结局
- Pain during and after treatment(Up to 5 years after treatment)
- Cost-effectiveness of the treatment(Up to 5 years after treatment)
- Changes in Quality of Life and symptoms(Up to 5 years after treatment)
研究者
Anna-Maija Itkonen
M.D.
Helsinki University Central Hospital