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

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ClinicalTrials.gov Identifier: NCT02422277
Recruitment Status : Unknown
Verified May 2015 by Tamer Zewin, Mansoura University.
Recruitment status was:  Recruiting
First Posted : April 21, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Tamer Zewin, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: LI-ESWT group Drug: PDE-5 inhibitors group Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation Shock

Arm Intervention/treatment
Active Comparator: 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.
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.

Other Name: shock wave group

Active Comparator: 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.

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.
Other Name: Sildenafil

No Intervention: Control group
Patients will be only followed up without any therapy for assisting erection.



Primary Outcome Measures :
  1. Improvement of sexual function by increase satisfaction and good vaginal penetration [ Time Frame: 6 MOTHES ]
    increase in IIEF score by 5 degrees



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

- 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422277


Contacts
Contact: Tamer S. Zewin, MS 0402103041 ext 01023500434 ahmed.harraz@hotmail.com
Contact: Ahmed M. Hazrra, MD 0402103041 ext 01023500434 ahmed.harraz@hotmail.com

Locations
Egypt
Urology and Nephrology Center Recruiting
Mansoura, DK, Egypt, 35516
Contact: Tamer E. Zewin, Fellow    0020502202222    zewin_tam@yahoo.com   
Contact: Ahmed M. Harraz, MD    0020502202222    ahmed.harraz@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
Study Director: Ahmed M. Asmy, MD a_assmy@yahoo.com

Responsible Party: Tamer Zewin, Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University, Mansoura University
ClinicalTrials.gov Identifier: NCT02422277     History of Changes
Other Study ID Numbers: TZewin132015
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by Tamer Zewin, Mansoura University:
Cystoprostatectomy
Sexual function
Phosphodiestrase 5 inhibitors
Low intensity extracorporeal shock wave therapy
Erectile dysfunction
Penile rehabilitation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action