Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|