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

Mansoura University

Status and phase

Unknown

Phase 2

Conditions

Bladder Cancer

Treatments

Device: LI-ESWT group

Drug: PDE-5 inhibitors group

Study type

Interventional

Funder types

Other

Identifiers

NCT02422277

TZewin132015

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.

Unstable medical or psychiatric disorder.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

LI-ESWT group

Active Comparator group

Description:

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.

Treatment:

Device: LI-ESWT group

PDE-5 inhibitors group

Active Comparator group

Description:

Intervention include that patients will intke oral tablets of PDE-5 inhibitors : - Oral intake of 50 mg once daily for 6 months.

Treatment:

Drug: PDE-5 inhibitors group

Control group

No Intervention group

Description:

Patients will be only followed up without any therapy for assisting erection.