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

Phase 2

• Conditions: Bladder Cancer
• Interventions: Device: LI-ESWT group; Drug: PDE-5 inhibitors group

• Registration Number: NCT02422277
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-06
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LI-ESWT group	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.
PDE-5 inhibitors 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.

Primary Outcome Measures

Name	Time	Method
Improvement of sexual function by increase satisfaction and good vaginal penetration	6 MOTHES	increase in IIEF score by 5 degrees

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, DK, Egypt