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

NCT ID: NCT02422277

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-30

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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LI-ESWT group

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

PDE-5 inhibitors group

Intervention Type DRUG

The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

PDE-5 inhibitors group

The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.

Intervention Type DRUG

Other Intervention Names

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shock wave group Sildenafil

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Zewin

Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M. Asmy, MD

Role: STUDY_DIRECTOR

[email protected]

Locations

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Urology and Nephrology Center

Al Mansurah, DK, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Tamer S. Zewin, MS

Role: CONTACT

0402103041 ext. 01023500434

Ahmed M. Hazrra, MD

Role: CONTACT

0402103041 ext. 01023500434

Facility Contacts

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Tamer E. Zewin, Fellow

Role: primary

0020502202222

Ahmed M. Harraz, MD

Role: backup

0020502202222

Other Identifiers

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TZewin132015

Identifier Type: -

Identifier Source: org_study_id

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