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

Mansoura University

Status: Completed

Conditions: Post Prostatectomy; Urgency-frequency Syndrome; Urinary Incontinence, Urge; Overactive Bladder

Treatments: Procedure: Li-SWT (perineal approach); Procedure: Li-SWT (suprapubic approach); Drug: Solifenacin; Procedure: Li-SWT (combined approach); Procedure: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04437108

Li-SWT after relief of BPO

Details and patient eligibility

About

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)

Full 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).

Enrollment: 132 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Li-SWT

Active Comparator group

Description:

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

Treatment:

Procedure: Li-SWT (combined approach)

Procedure: Li-SWT (perineal approach)

Procedure: Li-SWT (suprapubic approach)

Sham treatment

Sham Comparator group

Description:

Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.

Treatment:

Procedure: Sham treatment

antimuscarinics

Active Comparator group

Description:

Patients will be treated by solifenacin 10 mg once daily for 6 months.

Treatment:

Drug: Solifenacin