Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 Nm Er:YAG Laser Treatment for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
研究概览
简要总结
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.
详细描述
This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment.
Subjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up.
Secondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 80 years
- •SUI or MUI with predominantly stress symptoms for more than 6 months
- •Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)
- •Confirmed SUI through cough stress test or urodynamics
- •Has at least one incontinence episode per 24 hour period measured over three days
- •Valsalva leak-point pressure (VLPP) ≤100 cm H2O
- •Has a baseline 24h pad weight test ≥ 10 gm
- •Has maximum cystometric capacity ≥250 mL
- •No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
- •Willing to give informed consent and complete the follow up schedule
排除标准
- •Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)
- •Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- •Clinical diagnosis of urge incontinence or urge predominant mixed incontinence
- •Has detrusor overactivity on urodynamics
- •postvoiding residual (PVR) > 100 ml
- •Has had previous urethral surgery (i.e. fistula or diverticula)
- •Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade > 2 as defined by POP-Q and symptomatic
- •Suffers from known polyuria (>3l/24h)
- •Has a BMI ≤35 kg/m2
- •Has unevaluated hematuria
- •Has a neurogenic bladder
- •Evidence of dysplasia in a Pap smear (done in the last 24 months)
- •Tumours of the Urinary tract
- •Previous radiation or brachytherapy to treat pelvic cancer
- •Has uncontrolled diabetes
- •Has active herpes genitalis
- •Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months
- •Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit
- •Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit
结局指标
主要结局
Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
时间窗: 18 months
The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
时间窗: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events
时间窗: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
时间窗: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
时间窗: 18 months
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)
次要结局
- The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary(18 months)
- The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test(18 months)
- The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire(18 months)
- The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)(18 months)