Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Percent of responders
研究概览
简要总结
comparing the outcome of low-intensity shock wave therapy (Li-SWT) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (BPO)
详细描述
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in aging men including both voiding and storage symptoms. After prostatectomy, 20-30% of the patients still have persistent storage symptoms. The pathophysiology of persistent storage symptoms after surgical relief of benign prostatic obstruction (BPO) remains unclear. It may be due to bladder changes produced by long standing bladder outlet obstruction (BOO) including bladder ischemia and denervation or it may be related to other factors rather than preoperative BOO such as aging, chronic inflammation or a subtle neurological disorder.
After exclusion of urinary tract infection (UTI) and BOO, antimuscarinics are the commonly used medications for post-prostatectomy persistent storage symptoms. However, these medications are associated with side effects which may interfere with the patient compliance.
Low-intensity shock wave therapy (Li-SWT) is a non invasive procedure that has a beneficial effect in promoting revascularization and enhancing tissue regeneration. It has been applied to the penis for erectile dysfunction and to the perineum for chronic pelvic pain syndrome (CPPS) with encouraging results. In a rat model, it has been reported that defocused Li-SWT leads to improvement of bladder innervation and vascularization.
Based on the previously mentioned studies, the investigators hypothesized that Li-SWT can offer benefit in improvement of persistent storage symptoms after surgical relief of BPO. In the present study, the investigators will evaluate the effect of Li-SWT on persistent storage symptoms after transurethral surgery for BPO compared to antimuscarinics in a randomized controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients have to fulfill all the following criteria to be included in the study:
- •Ability to give informed consent and reply to questionnaires.
- •Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
- •Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.
排除标准
- •Patients who have any of the following will be excluded from the study:
- •Untreated UTI.
- •BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
- •Neurogenic lower urinary tract dysfunction (LUTD).
- •Uncontrolled diabetes mellitus.
- •Depression or any psychogenic disorders.
- •Prior radiation therapy to the pelvic area.
- •History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
- •Poor coagulopathy.
- •Severe cardiovascular disease.
研究组 & 干预措施
Li-SWT
Patients will be treated by 8 sessions of Li-SWT with one week interval. This group is subdivided into 3 subgroups according to the approach through which Li-SWT is applied; suprapubic, perineal and combined approaches
干预措施: Li-SWT (suprapubic approach) (Procedure)
Li-SWT
Patients will be treated by 8 sessions of Li-SWT with one week interval. This group is subdivided into 3 subgroups according to the approach through which Li-SWT is applied; suprapubic, perineal and combined approaches
干预措施: Li-SWT (perineal approach) (Procedure)
Li-SWT
Patients will be treated by 8 sessions of Li-SWT with one week interval. This group is subdivided into 3 subgroups according to the approach through which Li-SWT is applied; suprapubic, perineal and combined approaches
干预措施: Li-SWT (combined approach) (Procedure)
Sham treatment
Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.
干预措施: Sham treatment (Procedure)
antimuscarinics
Patients will be treated by solifenacin 10 mg once daily for 6 months.
干预措施: Solifenacin (Drug)
结局指标
主要结局
Percent of responders
时间窗: approximately 20 months
The percent of responders at 3-month follow up. Three points reduction in the total score of OABSS is determined as the minimal threshold for a meaningful change. Responders are defined as patients who achieved reduction in the total score of OABSS ≥ 3 at 3-month follow up, and those patients will continue on the same treatment modality.
The numerical change in overactive bladder symptoms score (OABSS)
时间窗: approximately 2 years.
The numerical change from baseline in the total score and sub-scores of OABSS at 3 and 6-month follow up will be reported.
The percent change in overactive bladder symptoms score (OABSS)
时间窗: approximately 20 months
The primary endpoint is the percent change from baseline in the total score of OABSS (total score = 15) at 3-month follow up.
3-day voiding diary
时间窗: approximately 2 years.
Change in daytime frequency (times/24hrs), urgency (times/24hrs), urge incontinence (times/24hrs), nocturia (times/24hrs) and average voided volume/micturition (ml) from baseline will be compared at 3 and 6-month follow up.
Incidence of adverse events associated with treatment
时间窗: approximately 18 months
Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.
次要结局
- International index of prostate symptom score (IPSS)(approximately 2 years.)
- Post voiding residual urine (PVR)(approximately 2 years.)
- Maximum flow rate (Qmax)(approximately 2 years.)
- International index of erectile function-15 ( IIEF-15)(approximately 2 years.)
- Cystometric bladder capacity(approximately 2 years.)
- Detrusor overactivity(approximately 2 years.)
- Detrusor contractility(approximately 2 years.)
研究者
Mohammed Hegazy
assistant lecturer of urology
Mansoura University