Clinical trial NCT04437108: Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO
Official title: Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Incontinence, Urge
Urgency-frequency Syndrome
Post Prostatectomy
Keywords: low-intensity shock wave therapy
persistent storage symptoms
benign prostatic obstruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Ahmed Mohamed Elshal
First posted: 2020-06-18
Enrollment: 132
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The percent change in overactive bladder symptoms score (OABSS)
timeFrame: approximately 20 months
measure: Percent of responders
timeFrame: approximately 20 months
measure: The numerical change in overactive bladder symptoms score (OABSS)
timeFrame: approximately 2 years.
measure: 3-day voiding diary
timeFrame: approximately 2 years.
measure: Incidence of adverse events associated with treatment
timeFrame: approximately 18 months
Secondary outcomes:
measure: International index of prostate symptom score (IPSS)
timeFrame: approximately 2 years.
measure: Post voiding residual urine (PVR)
timeFrame: approximately 2 years.
measure: Maximum flow rate (Qmax)
timeFrame: approximately 2 years.
measure: International index of erectile function-15 ( IIEF-15)
timeFrame: approximately 2 years.
measure: Cystometric bladder capacity
timeFrame: approximately 2 years.
measure: Detrusor overactivity
timeFrame: approximately 2 years.
measure: Detrusor contractility
timeFrame: approximately 2 years.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology center
Study officials:
affiliation: Urology and nephrology center, Mansoura, Egypt
name: Mohammed Hegazy
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and nephrology center, Mansoura, Egypt
name: Mohamed Gaballah
role: STUDY_DIRECTOR
affiliation: Urology and nephrology center, Mansoura, Egypt
name: Khaled Sheir
role: STUDY_DIRECTOR
affiliation: Urology and nephrology center, Mansoura, Egypt
name: Ahmed Elshal
role: STUDY_DIRECTOR
References: