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

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)

Conditions

• Overactive Bladder
• Urinary Incontinence, Urge
• Urgency-frequency Syndrome
• Post Prostatectomy

Interventions

PROCEDURE

Li-SWT (suprapubic approach)

The patient will be asked to lie in flat dorsal position. A commercially used gel for sonography will be applied to the suprapubic region. The applicator will be placed on suprapubic region with two fingers apart from the symphysis pubis tilting to 45°. Shock waves will be directed to 3 different sites; the midline (over the bladder dome) and 3 cm right and left to the midline (over bilateral bladder walls). The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.

PROCEDURE

Li-SWT (perineal approach)

The patient will be asked to lie in lithotomy position. A commercially used gel for sonography will be applied to the perineum. The applicator will be placed on perineal region. Shock waves will be directed to 3 different sites: the midline and 2 cm above and below the midline. The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.

PROCEDURE

Li-SWT (combined approach)

The patient will receive 3000 shocks; 1500 shocks through suprapubic approach (500 shocks per site) and another 1500 shocks through perineal approach (500 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.

PROCEDURE

Sham treatment

The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.

DRUG

Solifenacin

The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.

Sponsors & Collaborators

• Ahmed Mohamed Elshal

  collaborator UNKNOWN

• Mansoura University

  lead OTHER

Principal Investigators

• Mohammed Hegazy · Urology and nephrology center, Mansoura, Egypt

• Mohamed Gaballah · Urology and nephrology center, Mansoura, Egypt

• Khaled Sheir · Urology and nephrology center, Mansoura, Egypt

• Ahmed Elshal · Urology and nephrology center, Mansoura, Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-04

Primary Completion

2022-04-12

Completion

2022-07-21

Countries

• Egypt

Study Locations