Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy

Bladder Cancer Clinical Trial

Official title:

Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422277
• Other study ID #: TZewin132015
• Status: Recruiting
• Phase: Phase 2
• First received: April 16, 2015
• Last updated: May 4, 2015
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: May 2015
• Source: Mansoura University
• Contact: Tamer S. Zewin, MS
• Phone: 0402103041
• Email: ahmed.harraz[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.

Description:

60 patients for whom nerve sparing radical cystoprostatectomy will be carrried out, penile rehabilitation by using low intensity extracorporeal shock wave therapy will be applied in 20 patients, another 20 patients will receive oral phosphodiestrase type 5 inhibitorrs and 20 patients will not receive any interventions in the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients will be eligible if he is sexually motivated and potent men with stable relationship of more than 6 months duration who will undergo nerve sparing radical cysto-prostatectomy for organ-confined bladder cancer.

Exclusion Criteria:

• 1. Men with Peyronie's disease. 2. Inflammation in the shock wave area. 3. Evidence of disease failure after surgery. 4. Patients developing postoperative complications requiring hospital readmission after surgery which interferes with the process of SWL.

5. Unstable medical or psychiatric disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of sexual function by increase satisfaction and good vaginal penetration	increase in IIEF score by 5 degrees	6 MOTHES	Yes