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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: LI-ESWT group
* Drug: PDE-5 inhibitors group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LI-ESWT group<br>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<br>* 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.<br>* Other names: shock wave group;|
| Active Comparator: PDE-5 inhibitors group<br>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<br>* The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.<br>* Other names: Sildenafil;|
| No Intervention: Control group<br>Patients will be only followed up without any therapy for assisting erection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sexual function by increase satisfaction and good vaginal penetration | increase in IIEF score by 5 degrees | 6 MOTHES | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystoprostatectomy, Sexual function, Phosphodiestrase 5 inhibitors, Low intensity extracorporeal shock wave therapy, Erectile dysfunction, Penile rehabilitation