A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics.
研究概览
简要总结
The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based procedure, negating the need for an anaesthetic and hospital admission. The investigators null hypothesis is that there is no difference in subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.
Eligible women will be initially assessed with a full history and examination, King's Health Questionnaire and twin channel subtraction cystometry. They will be randomised (using a series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective assessment and repeat twin channel cystometry.
详细描述
Description Randomised, prospective study. Objective and subjective outcomes to be evaluated 6 weeks an d6 months post-operatively.
Study population The number of patients enrolled in the study will be decided after consultation with a statistician.
All patients will be recruited from urogynaecology clinics at Medway Maritime Hospital. They will be female and have a urodynamic diagnosis of stress incontinence, having failed conservative management. Those deemed suitable for the TVT operation will be offered entry to the study.
Randomisation and blinding
Patients who have consented to take part in the study will be randomised to have either a conventional TVT (Group A) or a MiniArc (Group B). Each group will be run in parallel. Method of randomisation - consecutively numbered opaque envelopes detailing type of operation.
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 (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be female
- •Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- •Stress incontinence on urodynamics
- •Patients who are capable of understanding and signing the written consent form for participation in the study
- •Patients must have completed their family
- •Patients must be capable of filling in the symptom diary and micturition diary
排除标准
- •Patients who are medically unfit to undergo surgical intervention.
- •Patients who have undergone previous continence surgery
- •Prolapse beyond the introitus
- •Patients with voiding dysfunction
- •Patients with recurrent urinary tract infections
- •Patients with haematuria of unknown origin or known bladder pathology
- •Patients who are not sure that their family is complete
- •Patients unwilling to use a safe method of contraception following the procedure
结局指标
主要结局
The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics.
时间窗: 6 weeks and 6 months
次要结局
- Quality of life (as measured using the King's Health Questionnaire)(6 weeks and 6 months)
- Intra-operative complications, e.g. bladder injury(Time of surgery)
- Post-operative voiding dysfunction(0-6 weeks)