Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
|ClinicalTrials.gov Identifier: NCT02422277|
Recruitment Status : Unknown
Verified May 2015 by Tamer Zewin, Mansoura University.
Recruitment status was: Recruiting
First Posted : April 21, 2015
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: LI-ESWT group Drug: PDE-5 inhibitors group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||September 2017|
Active Comparator: LI-ESWT group
Intervention include that patients will undergo penile low-intensity extracorporeal shock wave therapy, 6-12 sessions, 1500 shocks per session, two sesssions per week for 3 weeks then 3 weeks break and then 2 sessions per week for 3 weeks.
Device: LI-ESWT group
The patients in this arm will be subjected to Penile LI-SWT in the following parameters: 6 to 12 sessions with 1500 shocks per session. Each session will comprise the application of 300 shock waves (energy intensity of 0.09 mJ/mm2) to each of five different sites on the penis: three along the penile shaft and two at the crura with Frequency: 4 HZ. Energy level: 8 mJ/mm2. Rate: 120 shocks per minute.
-Intervals: 2 treatment sessions per week for 3 weeks, then 3-weeks no-treatment interval, then 3-weeks treatment period of 2 treatment sessions per week.
Other Name: shock wave group
Active Comparator: PDE-5 inhibitors group
Intervention include that patients will intke oral tablets of PDE-5 inhibitors :
- Oral intake of 50 mg once daily for 6 months.
Drug: PDE-5 inhibitors group
The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.
Other Name: Sildenafil
No Intervention: Control group
Patients will be only followed up without any therapy for assisting erection.
- Improvement of sexual function by increase satisfaction and good vaginal penetration [ Time Frame: 6 MOTHES ]increase in IIEF score by 5 degrees
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422277
|Contact: Tamer S. Zewin, MS||0402103041 ext email@example.com|
|Contact: Ahmed M. Hazrra, MD||0402103041 ext firstname.lastname@example.org|
|Urology and Nephrology Center||Recruiting|
|Mansoura, DK, Egypt, 35516|
|Contact: Tamer E. Zewin, Fellow 0020502202222 email@example.com|
|Contact: Ahmed M. Harraz, MD 0020502202222 firstname.lastname@example.org|
|Study Director:||Ahmed M. Asmy, MDemail@example.com|