Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months
研究概览
简要总结
Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP.
The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery.
Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.
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
- •Female patients, age 18 or greater, with a pelvic organ prolapse stage II to IV as defined by the POP-Q system
- •Patient is a candidate for prolapse repair surgery (as based on history and physical examination)
- •Patient is capable to fill out bladder diaries and questionnaires and understands the Dutch written and spoken language
排除标准
- •Patients who currently use anticholinergic medication
- •Patients with neurological causes of OAB
- •Patients who are pregnant
- •Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery
结局指标
主要结局
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months
时间窗: At baseline before surgery and at 6 months after surgery
The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months
时间窗: At baseline before surgery and at 6 months after surgery
The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic).
The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months
时间窗: At baseline before surgery and at 12 months after surgery
The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic).
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 12 months
时间窗: At baseline before surgery and at 12 months after surgery
次要结局
- Cystoscopic assessment of trabeculation(At time of surgery)
- Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months(At baseline before surgery and at 12 months after surgery)
- Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months(At baseline before surgery, at 6 and 12 months after surgery)
- Change from baseline in POP-Q stage at 6 and 12 months(At baseline before surgery, at 6 and 12 months after surgery)
- Change from baseline in concentration of urinary biomarkers at 12 months(At baseline before surgery and at 12 months after surgery)