Pessary Use for Stress Urinary Incontinence in Pregnancy: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PFDI-20 score difference and variance
研究概览
简要总结
When women are pregnant they are more likely to leak urine which can severely affect their quality of life. This problem could be fixed by using a pessary. A pessary is a silicone ring that goes into the vagina which can stop or improve urinary leakage. These devices have been safely used for hundreds of years. However, pessaries has not been studied for urinary leakage in pregnancy. The investigators would like to compare severity of urinary leakage using a number of questionnaires during the last 3 months of pregnancy for women using a pessary versus women without a pessary.
详细描述
Specific Aims To determine if an incontinence pessary will improve condition-specific quality of life for women with stress urinary incontinence (SUI) in the third trimester of pregnancy and collect pilot data to inform sample size and feasibility for a larger randomized controlled trial.
Background/Significance The prevalence of antenatal urinary incontinence (UI) in nulliparous women is 30-40%; the prevalence increases with multiparity and prior vaginal delivery. Stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) are reported by 37% and 58% of gravidas respectively. Fifty percent of all new UI in pregnancy is SUI. As pregnancy progresses the prevalence of SUI increases from 8.3% to 36.9% in the third trimester. The frequency, volume and severity of the UI worsens with increasing gestational age, resulting in increasingly profound effects on women's daily life. These concerns are often underreported and under recognized by clinicians. SUI in pregnancy is currently managed with pelvic floor exercises, associated with incomplete symptom relief, suboptimal patient adherence and limited evidence.
Incontinence pessaries can be a ring or a dish with an incontinence knob. These pessaries decrease UI by providing compression and support to the urethra. Up to 63% of non-pregnant women fitted with an incontinence pessary are satisfied with the treatment at 3 months; after one year of use 50-59% of women remain satisfied and one third have "no bothersome SUI symptoms". Pessaries are a low risk and effective option to manage UI. The use of incontinence pessaries is supported for the treatment of SUI in non-pregnant women by the Society of Obstetrics and Gynaecology of Canada.
Pessaries are safe in pregnancy and have been reported for the management of cervical insufficiency, pelvic organ prolapse, and incarcerated uterus. While some believe pregnant women are ideal candidates for incontinence pessaries, supporting evidence is required. There are currently no obstetrical guidelines supporting pessary use for incontinence in pregnancy despite pessaries being a low risk treatment option; clinicians are currently limited to offering pelvic floor exercises for antepartum urinary incontinence. Pessaries are a safe and effective management option for UI in pregnancy and they can be managed independently by the patient.
Stress urinary incontinence represents a common concern in pregnancy and lacks evidence-based treatment options. In this pilot trial, the investigators propose to quantify the effect of incontinence pessaries on condition-specific quality of life and SUI symptoms in pregnant women, and to determine rate of successful pessary fitting, treatment acceptability, sexual function, patterns of adherence, discontinuation rate, adverse events and global impression of improvement. Our trial will provide important evidence for a much-needed larger clinical trial aiming to investigate incontinence pessaries as a treatment option for SUI in pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking women over 19 years old
- •Nulliparous and multiparous women over 26 weeks gestational age with a healthy singleton pregnancy
- •Bothersome symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence with a minimal PDFI score of 25 on the UDI-6 section.
排除标准
- •Stage 3 or greater pelvic organ prolapse
- •Contraindication to pessary use (known pelvic infection, vaginal or cervical lesions)
- •Previous surgery for urinary incontinence
- •History of preterm delivery and current threatened preterm labour
- •Premature preterm rupture of membranes
- •Short cervix
- •Hospitalization in the current pregnancy
- •Antepartum hemorrhage
- •Fetal anomaly
- •Prior trial of pessary or current pessary use
- •Vulvodynia
结局指标
主要结局
PFDI-20 score difference and variance
时间窗: At exit interview (36 weeks gestational age)
Pelvic Floor Disability Inventory (PFDI-20) score differences and variance between; intervention and control arms at 36 weeks gestational age; range 0-100; higher scores are a worse outcome.
次要结局
- Pelvic Floor Impact Questionnaire (PFIQ-7) score(At exit interview (36 weeks gestational age))
- Pessary expulsion(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Pessary Usability(At exit interview (36 weeks gestational age))
- Pessary fitting and success(up to 24 months)
- evaluate study retention rates(up to 24 months)
- Incomplete emptying(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Vaginal Bleeding(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Rupture of membranes(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Pelvic pain(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Number of daily hours of pessary use(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Bladder Diary(At exit interview (36 weeks gestational age))
- Female Sexual Function Index (FSFI) score(At exit interview (36 weeks gestational age))
- Vaginal discharge(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Abdominal Pain(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Difficult inserting the pessary(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Difficulty with sexual activity(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Delivery(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Difficult removing pessary(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Hospital Admission(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
- Group B strep Positive(Biweekly from 28 weeks gestational age to 36 weeks gestational age)
研究者
Catherine Smith
Clinical Administrator, Advanced Training in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) program
University of British Columbia