Evaluation of the Impact of Preoperative Pelvic Floor Exercise on Incontinence After Laser Enucleation of the Prostate: a Prospective Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinician-Reported Feasibility of a Preoperative Pelvic Floor Physiotherapy Program (Urologists and Physiotherapists) Assessed by the Program Integration and Perceived Continence Benefit Questionnaire
研究概览
简要总结
The purpose of this study is to assess the acceptability and feasibility of including a pelvic floor muscle exercise program into the care provided to patients undergoing prostate enucleation, studying both patients and clinicians perpsectives. A second part of the study will be to compare two groups, one receiving pelvic floor muscle exercise before surgery and and the other receiving the standard treatment, which is surgery. We will evaluate patients' perceptions of integrating physiotherapy sessions before surgery and attempt to identify facilitators and barriers to pelvic floor muscle exercise among both patients and clinicians.
详细描述
NATURE AND OBJECTIVES OF THE PROJECT
With aging, prostate enlargement, or benign prostatic hyperplasia (BPH), is very common in men. BPH can obstruct the urinary tract and result in urinary dysfunction. While some patients affected by BPH do not experience symptoms, others may have difficulty urinating or lose control of the bladder. To reduce these bothersome symptoms, patients may undergo a procedure called prostate enucleation, which involves using a laser to remove the portion of the prostate that obstructs the urinary tract.
Unfortunately, in some cases, patients may develop urinary incontinence after surgery. The rate of incontinence can vary greatly from person to person. Several risk factors may increase this likelihood, such as advanced age, diabetes, obesity, or a large prostate.
In general, the majority of patients recover and no longer have incontinence after 6 months (<1%). However, some patients who develop incontinence after surgery may still experience an impact on quality of life. Pelvic floor physiotherapy is often recommended for patients with incontinence after prostate surgery. However, very few studies have evaluated the effectiveness of preoperative pelvic floor physiotherapy in preventing urinary incontinence.
The purpose of this study is to assess the acceptability and feasibility of including a pelvic floor muscle exercise program in the care provided to patients undergoing prostate enucleation by studying both patient and clinician perspectives. A second part of the study will compare two groups: one receiving pelvic floor muscle exercises before surgery and the other receiving standard treatment (surgery only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic BPH who are candidates for prostate enucleation, including: urinary retention, post-renal AKI, refractory hematuria, recurrent UTIs, symptoms refractory to medical therapies, IPSS > 8, urinary flow rate < 15 mL/sec.
- •Patients able to perform pelvic floor physiotherapy exercises independently.
- •Patients who agree to additional outpatient physiotherapy visits.
- •Patients who provide consent to participate in the study.
排除标准
- •Patients with severe central or peripheral neurological diseases and gait disorders
- •Patients with a history of prostate or bladder cancer, prior prostate surgery, neurogenic bladder, or urethral stricture
- •Patients with bladder atony
- •Patients unable to continue pelvic floor muscle training independently
研究组 & 干预措施
Standard of care
No intervention, standard of care administrated.
Intervention - Pelvic Floor Muscle Exercise
Three sessions of 30 minutes will be scheduled (2 before the surgery and one after the surgery) with a specialized pelvic rehabilitation physiotherapist.
Teaching pelvic floor physiotherapy exercises.
干预措施: Pelvic Floor Muscle Exercise before and after surgery (Other)
结局指标
主要结局
Clinician-Reported Feasibility of a Preoperative Pelvic Floor Physiotherapy Program (Urologists and Physiotherapists) Assessed by the Program Integration and Perceived Continence Benefit Questionnaire
时间窗: From enrollment to 3-5 months after surgery
Program Integration and Perceived Continence Benefit Questionnaire. A majority (\>50%) of clinicians are expected to agree with the 6 questionnaire items (\>3/5 on the Likert scale, as lowest score is 1 = strongly disagree to highest score being 5 = strongly agree, for a total score range of 6 to 30. Higher score meaning better outcome.) At least 60% of preoperative pelvic floor physiotherapy (PPP) sessions will be delivered to participants prior to surgery.
Patient Acceptability of the Perineal Physiotherapy Program as Measured by Patient Acceptability of a Postoperative Pelvic Floor Physiotherapy Program After Endoscopic Prostate Enucleation Questionnaire (PPP-EEP) and Percentage of Session Attendance
时间窗: From enrollment to 3-5 months after surgery
Patient Acceptability of a Postoperative Pelvic Floor Physiotherapy Program After Endoscopic Prostate Enucleation Questionnaire (PPP-EEP). A majority (\>50%) of patients should agree with the 6 items on the questionnaire (score \>3/5 on the Likert scale, as lowest score is 1 = strongly disagree to highest score being 5 = strongly agree, for a total score range of 6 to 30. Higher score meaning better outcome). Attendance of ≥60% at physiotherapy sessions will be considered acceptable.
次要结局
未报告次要终点