Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
Overview
- Phase
- Phase 2
- Intervention
- LI-ESWT group
- Conditions
- Bladder Cancer
- Sponsor
- Mansoura University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement of sexual function by increase satisfaction and good vaginal penetration
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Tamer Zewin
Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University
Mansoura University
Eligibility Criteria
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
- •Men with Peyronie's disease.
- •Inflammation in the shock wave area.
- •Evidence of disease failure after surgery.
- •Patients developing postoperative complications requiring hospital readmission after surgery which interferes with the process of SWL.
- •Unstable medical or psychiatric disorder.
Arms & Interventions
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.
Intervention: LI-ESWT group
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.
Intervention: PDE-5 inhibitors group
Outcomes
Primary Outcomes
Improvement of sexual function by increase satisfaction and good vaginal penetration
Time Frame: 6 MOTHES
increase in IIEF score by 5 degrees