Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence: Effectiveness And Patient Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Effectiveness of the Contiform intravaginal pessary to achievement a change of 50 % or greater reduction in pad weight at 3 months compare to baseline
研究概览
简要总结
Stress urinary incontinence (SUI) is a highly prevalent condition of involuntary urine leakage associated with coughing, sneezing or exertion. Midurethral slings (MUS) are a safe and efficacious surgical option to treat SUI and is considered the best treatment by recognized organizations. Nevertheless, it remains a surgical intervention exposing patients to risks, possible recurrence and is not recommended to women planning to have more children. Incontinence pessaries offer an alternative to surgery with a similar mechanism of action as MUS. However, there is a paucity of literature on the outcomes of incontinence pessary treatment of SUI, with only two prospective studies have been published on the Uresta pessary and one australian case-series on Contiform pessary.
The objective of the study is to evaluate the effectiveness of the self-positioning Contiform intravaginal pessary used as a conservative method to address stress urinary incontinence in women in order to provide Canadian real-world data.
The 3-month efficacy, adverse events and global patient satisfaction (including comfort and ease of insertion) will be assessed.
It is hypothesized that the Contiform device will be well tolerated by 60-70% of patients, with no serious adverse events. It will cure SUI for about 50% of them.
详细描述
Patient who will present to the investigator's tertiary urology clinic with the main complaint of stress incontinence will be invited to consider the Contiform device. A total of 50 women will be recruited and followed over 3 months.
The evaluation of enrolled women will include a medical history and physical examination, a urinalysis, a urine culture, three-day voiding diary and post-void residual (PVR). Urodynamic testing will not be required. Kegel assessment will be performed on physical pelvic exam based on the Oxford subjective scale, which ranged from 0 (no palpable contraction) to 5 (very strong contraction). Demographic and baseline characteristics of the participants will be recorded, medical condition and medication.
Patients will be offered the Contiform device and invited to join the study as one treatment option for their stress leak. Patients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. All postmenopausal women will be given topical vaginal estrogen therapy before or on the day of starting using the device. No other treatment will be initiated during the trial period.
Once enrolled, patients will be given brief verbal and written instructions on pessary insertion and cleaning, and then allowed to select and insert the pessary themselves at home. They will be provided with a New User Kit which comprises three available sizes (Small, Medium & Large) and a Silicone Removal Strap.
Patient enrolled will have to sign a informed consent form and agree that all information obtained during the research will be kept and treated confidentially within the limits of the law. The results of this study may be published or communicated in other ways; however, no identity or any other identifying information will not be disclosed in any reports or publications. The confidential records and data may be kept up to 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Complain of stress incontinence
- •Sufficient manual dexterity to insert and remove the device;
- •Ability to speak French or English and understand written informed consent as per local ethical committee approval.
排除标准
- •a main complaint of urgency symptoms, bacterial cystitis (symptomatic or proven UTI) at the time of insertion, recent pelvic surgery within the last 3 months, previous pelvic radiotherapy, current pregnancy, failed use of an incontinence pessary, a functional bladder capacity on bladder diary less than 250 mL, prolapse of any vaginal compartment beyond the level of the hymen, post-void residual urine volume greater than 100 mL, hematuria, undiagnosed pelvic or vaginal bleeding
研究组 & 干预措施
Contiform pessary
Enrolled participants will be part of the intervention arm. They will use of the Contiform Intravaginal pessary for the treatment of stress urinary incontinence, for a period of 3 months.
干预措施: Contiform pessary (Device)
结局指标
主要结局
Effectiveness of the Contiform intravaginal pessary to achievement a change of 50 % or greater reduction in pad weight at 3 months compare to baseline
时间窗: 3 months
The primary outcome measure will be the 24-h pad test before and after device placement. In order to determine whether the device is equally effective in mild or more severe leakage, two groups will be analyzed separately. A leakage of \<100 g/24h will be categorized as "mild loss" and \>100 g/24h will be termed "moderate/severe loss". A weight of less than 2 g will be considered normal. Baseline data will be compare to 3 months to assess change.
次要结局
- Patient quality of life and urinary incontinence symptoms as assessed by the ICIQ(4 weeks and 3 months)
- Patient quality of life and discomfort regarding their urinary incontinence symptoms as assessed by the UDI-6(4 weeks and 3 months)
- Assessment of augmentation of residual urine volume as an adverse event(4 weeks and 3 months)
- Assessment of any new adverse symptoms(4 weeks and 3 months)
- Assessment of vaginal adverse event(4 weeks and 3 months)
- Patient perception of efficacy and their acceptability of the device as assessed by the PGI-I(4 weeks and 3 months)
- Patient acceptability and use of the device, as assessed by the Pessary Use Questionnaire(4 weeks and 3 months)
- Assessment of device defect(4 weeks and 3 months)