Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO

Not Applicable

Completed

• Conditions: Urgency-frequency Syndrome; Overactive Bladder; Post Prostatectomy; Urinary Incontinence, Urge
• Interventions: Procedure: Li-SWT (suprapubic approach); Procedure: Sham treatment; Drug: Solifenacin; Procedure: Li-SWT (perineal approach); Procedure: Li-SWT (combined approach)

• Registration Number: NCT04437108
• Lead Sponsor: Mansoura University

Brief Summary

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)

Detailed Description

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).

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-07-04
• Primary Completion: 2022-04-12
• Study Completion: 2022-07-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 132

Inclusion Criteria

• Patients have to fulfill all the following criteria to be included in the study:

  1. Ability to give informed consent and reply to questionnaires.
  2. Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
  3. Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.

Exclusion Criteria

• Patients who have any of the following will be excluded from the study:

  1. Untreated UTI.
  2. BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
  3. Neurogenic lower urinary tract dysfunction (LUTD).
  4. Uncontrolled diabetes mellitus.
  5. Depression or any psychogenic disorders.
  6. Prior radiation therapy to the pelvic area.
  7. History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
  8. Poor coagulopathy.
  9. Severe cardiovascular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Li-SWT	Li-SWT (combined approach)	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
Li-SWT	Li-SWT (suprapubic approach)	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
Sham treatment	Sham treatment	Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.
Li-SWT	Li-SWT (perineal approach)	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
antimuscarinics	Solifenacin	Patients will be treated by solifenacin 10 mg once daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Percent of responders	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)	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)	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	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	approximately 18 months	Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.

Secondary Outcome Measures

Name	Time	Method
International index of prostate symptom score (IPSS)	approximately 2 years.	Change in IPSS at 0, 3 and 6 months will be compared.
Post voiding residual urine (PVR)	approximately 2 years.	Change in PVR (ml) at 0, 3 and 6 months will be compared.
Maximum flow rate (Qmax)	approximately 2 years.	Change in Qmax (ml/s) at 0, 3 and 6 months will be compared.
International index of erectile function-15 ( IIEF-15)	approximately 2 years.	Change in IIEF-15) at 0, 3 and 6 months will be compared.
Cystometric bladder capacity	approximately 2 years.	Change in bladder volume (ml) at first sensation of filling and maximum cystometric capacity (ml) at 0 and 6 months will be analysed.
Detrusor overactivity	approximately 2 years.	Change in detrusor stability and maximum amplitude (cmH2O) of detrusor overactivity during cystometry at 0 and 6 months will be analysed.
Detrusor contractility	approximately 2 years.	Change in maximum detrusor pressure (cmH2O) and BCI during voiding at 0 and 6 months will be analysed.

Trial Locations

Locations (1)

Urology and Nephrology center; 🇪🇬 Mansoura, Egypt