NCT02422277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 16, 2015

Last Update Submit

May 4, 2015

Conditions

Bladder Cancer

Keywords

CystoprostatectomySexual functionPhosphodiestrase 5 inhibitorsLow intensity extracorporeal shock wave therapyErectile dysfunctionPenile rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Improvement of sexual function by increase satisfaction and good vaginal penetration

    increase in IIEF score by 5 degrees

    6 MOTHES

Study Arms (3)

LI-ESWT group

ACTIVE COMPARATOR

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

PDE-5 inhibitors group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

LI-ESWT groupDEVICE

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.

Also known as: shock wave group
LI-ESWT group
PDE-5 inhibitors groupDRUG

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

Also known as: Sildenafil
PDE-5 inhibitors group

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsErectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Diseases, MaleGenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed M. Asmy, MD

    a_assmy@yahoo.com

    STUDY DIRECTOR

Central Study Contacts

Tamer S. Zewin, MS

CONTACT

0402103041ahmed.harraz@hotmail.com

Ahmed M. Hazrra, MD

CONTACT

0402103041ahmed.harraz@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

EG(1)