Back to results

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

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

LI-ESWT group

PDE-5 inhibitors group

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Cystoprostatectomy, Sexual function, Phosphodiestrase 5 inhibitors, Low intensity extracorporeal shock wave therapy, Erectile dysfunction, Penile rehabilitation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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.

5. Unstable medical or psychiatric disorder.

Sites / Locations

Urology and Nephrology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

LI-ESWT group

PDE-5 inhibitors group

Control group

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Improvement of sexual function by increase satisfaction and good vaginal penetration

increase in IIEF score by 5 degrees

Secondary Outcome Measures

Full Information

NCT ID

NCT02422277

First Posted

April 16, 2015

Last Updated

May 4, 2015

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02422277

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Cystoprostatectomy, Sexual function, Phosphodiestrase 5 inhibitors, Low intensity extracorporeal shock wave therapy, Erectile dysfunction, Penile rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LI-ESWT group

Arm Type

Active Comparator

Arm Description

Arm Title

PDE-5 inhibitors group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

LI-ESWT group

Other Intervention Name(s)

shock wave group

Intervention Description

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

Drug

Intervention Name(s)

PDE-5 inhibitors group

Other Intervention Name(s)

Sildenafil

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of sexual function by increase satisfaction and good vaginal penetration

Description

increase in IIEF score by 5 degrees

Time Frame

6 MOTHES

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tamer S. Zewin, MS

Phone

0402103041

Ext

01023500434

ahmed.harraz@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed M. Hazrra, MD

Phone

0402103041

Ext

01023500434

ahmed.harraz@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M. Asmy, MD

Organizational Affiliation

a_assmy@yahoo.com

Official's Role

Study Director

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamer E. Zewin, Fellow

Phone

0020502202222

zewin_tam@yahoo.com

First Name & Middle Initial & Last Name & Degree

Ahmed M. Harraz, MD

Phone

0020502202222

ahmed.harraz@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs