Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence (Darifenacin for Treatment of Women With Dual Incontinence)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- change in FI symptom severity
研究概览
简要总结
This observational research study will examine whether a medication known as darifenacin (Enablex ®) used for urgency urinary incontinence (UUI) also helps to improve fecal incontinence symptoms. Darifenacin is FDA approved for UUI, but is not FDA approved for fecal incontinence or specifically for dual incontinence (treatment of urinary incontinence and fecal incontinence at the same time). If participants are eligible for this study, they will have had symptoms of bothersome urgency urinary incontinence and fecal incontinence, and have decided to try medication for urgency urinary incontinence. Darifenacin (Enablex ®) is an oral medication which relaxes the bladder muscle to help prevent urgency urinary leakage. It is commonly used to treat overactive bladder and urgency urinary leakage. There is some evidence that this medication may also help with fecal incontinence by slowing the gut and preventing loose stools. Investigators are planning to enroll approximately 30 patients who have both UUI and fecal incontinence and who choose medical treatment as a part of their standard care.
详细描述
Urgency urinary incontinence (UUI) and fecal incontinence (FI) are two highly prevalent pelvic floor disorders which negatively impact quality of life (QOL). Among women with urgency urinary incontinence (UUI), 8-20% also suffer from FI.
Initial management of both UUI and FI consists of behavioral therapies with or without pharmacologic management. First line management of FI includes diet, fluid and fiber intake adjustments (Grade A), antidiarrheal medication (Grade B) and exercises to strengthen and enhance awareness of the anal sphincter (Grade C). If symptoms fail to improve with these measures by 8-12 weeks, further investigations should be considered before moving to more invasive management options such as bulking agents, sphincterplasty or sacral nerve stimulation.
In addition to fiber and antidiarrheals, medications with antimuscarinic effects such as hyoscyamine and tricyclic antidepressants are often used in the treatment of FI and IBS-D. Antimuscarinic medications function in this setting by blockade of colonic muscarinic acetylcholine receptors causing smooth muscle relaxation, decreased gut motility and prolonged colon transit time.
In patients with overactive bladder (OAB) with UUI, anti-muscarinic medications or a β3-adrenoreceptor agonist medication can be added to behavioral therapy as first line to optimize symptom control and QOL (Gormley 2015). In patients being treated for UUI, constipation is often viewed as an unwanted side effect of antimuscarinic medications, with varying constipation rates observed among the different medications. Non-selective antimuscarinic medications such as fesoterodine (Toviaz ®) and tolterodine (Detrol ®) may be less likely to cause constipation, whereas newer M2 or M3-selective agents such as darifenacin (Enablex ®), solifencin (Vesicare®) or trospium (Sanctura ®) may be more constipating. Darifenacin is notable for the highest constipation rates- up to 15% for the 7.5mg dose, and up to 21% for the 15mg dose.
While there is no current evidence for one specific antimuscarinic medication use in patients suffering with dual incontinence (specifically UUI and FI), many providers use the more constipating antimuscarinic medications as treatment in this setting. Patients with loose-stool-predominant FI may benefit from the constipating side effects by slowed colonic transit time, firmer bowel movements and thereby improved bowel-related QOL. Only one study has previously examined the effect of antimuscarinic medication for OAB on bowel-related QOL. In this descriptive study, 90 patients who were treated with antimuscarinic medication for OAB were followed to measure change in ePAQ (electronic Personal Assessment Questionnaire) score. Investigators reported significant improvement in bowel-related QOL three to six months after treatment. Authors did not specify pre-treatment diagnoses, symptoms or details of the antimuscarinic treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Women ≥18yrs presenting to UAB urogynecology and continence clinics with co-occurring UUI and FI
- •Willing to complete all study related items
排除标准
- •Severe constipation, fecal impaction or overflow fecal incontinence
- •Inflammatory bowel disease, colorectal CA, spinal cord injury, multiple sclerosis, stroke, myasthenia gravis
- •Infectious diarrhea
- •Bothersome SUI (defined as "moderately" or greater bother on UDI-3)
- •Patients planning to undergo surgery during study period
- •Patients who are pregnant or intending to become pregnant during the study period
- •Patients with contraindications to antimuscarinic medications (ie. closed angle glaucoma)
- •Patients on unstable or changing dosage of fiber or narcotics in the past 14 days
- •Patients taking more than 2mg/day of loperamide (patients taking more than 2mg will be required a 2 week washout period)
- •Patients currently taking medication for urgency urinary incontinence (these patients will also require a 2 week washout period)
- •Patients initiating care with a pelvic floor physical therapist during the study period
结局指标
主要结局
change in FI symptom severity
时间窗: 8 weeks
to be measured by questionnaire and bowel diary Questionnaire to be used is the Vaizey scale which measures fecal incontinence severity. Minimum score is 0 (perfect continence; best) and maximum score is 24 (total incontinence; worse). There is no subscale. Bowel diary is a weeklong record of each bowel movement the patient has. there is no standardized scoring or scale.
次要结局
- post-treatment change in FI frequency(8 weeks)
研究者
Lindsay M Kissane
MD
University of Alabama at Birmingham