Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
NCT ID: NCT02422277
Last Updated: 2015-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-03-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
PDE-5 inhibitors group
The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.
Control group
Patients will be only followed up without any therapy for assisting erection.
No interventions assigned to this group
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5\. Unstable medical or psychiatric disorder.
30 Years
75 Years
MALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Tamer Zewin
Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University
Principal Investigators
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Locations
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Urology and Nephrology Center
Al Mansurah, DK, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TZewin132015
Identifier Type: -
Identifier Source: org_study_id
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