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

NACompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

July 4, 2020

Primary Completion Date

April 12, 2022

Study Completion Date

July 21, 2022

Conditions
Overactive BladderUrinary Incontinence, UrgeUrgency-frequency SyndromePost 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.

Trial Locations (1)

35516

Urology and Nephrology center, Al Mansurah

All Listed Sponsors
collaborator

Ahmed Mohamed Elshal

UNKNOWN

lead

Mansoura University

OTHER

NCT04437108 - Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO | Biotech Hunter | Biotech Hunter