Bladder CancerPhase 2NCT02422277
Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
A Phase 2 study testing LI-ESWT group and PDE-5 inhibitors group in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- LI-ESWT group and PDE-5 inhibitors group
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, DK, 35516
Tamer E. Zewin, Fellow, 0020502202222, zewin_tam@yahoo.com
Ahmed M. Harraz, MD, 0020502202222, ahmed.harraz@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- LI-ESWT group, PDE-5 inhibitors group
- Keywords
- Cystoprostatectomy, Sexual function, Phosphodiestrase 5 inhibitors, Low intensity extracorporeal shock wave therapy, Erectile dysfunction, Penile rehabilitation
- Medical subject headings
- Urinary Bladder Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LI-ESWT groupDevice
Also called shock wave 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.
PDE-5 inhibitors groupDrug
Also called Sildenafil
The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PDE-5 inhibitors group |
| Control group | No intervention | Patients will be only followed up without any therapy for assisting erection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of sexual function by increase satisfaction and good vaginal penetration
increase in IIEF score by 5 degrees
Measured: 6 MOTHES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Zewin, Mansoura University
- Investigators
- Ahmed M. Asmy, MD, Study director, a_assmy@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422277
- Sponsor's protocol ID
- TZewin132015
- Status last verified
- May 2015
- First submitted
- 16 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
- ClinicalTrials.gov ID
- NCT02422277
- Acronym / sponsor ID
- TZewin132015
- Conditions
- Bladder Cancer
- Keywords
- Cystoprostatectomy, Sexual function, Phosphodiestrase 5 inhibitors, Low intensity extracorporeal shock wave therapy, Erectile dysfunction, Penile rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LI-ESWT group | Active comparator | Device: LI-ESWT groupIntervention 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. |
| PDE-5 inhibitors group | Active comparator | Drug: PDE-5 inhibitors groupIntervention include that patients will intke oral tablets of PDE-5 inhibitors : - Oral intake of 50 mg once daily for 6 months. |
| Control group | No intervention | –Patients will be only followed up without any therapy for assisting erection. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LI-ESWT groupAlso: shock wave groupThe 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. | Device | LI-ESWT group |
| PDE-5 inhibitors groupAlso: SildenafilThe patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes. | Drug | PDE-5 inhibitors group |
Primary outcome
Improvement of sexual function by increase satisfaction and good vaginal penetration
Time frame: 6 MOTHES
increase in IIEF score by 5 degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M. Asmy, MD study director
a_assmy@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LI-ESWT group and PDE-5 inhibitors group in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamer S. Zewin, MS (0402103041 ext. 01023500434, ahmed.harraz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of sexual function by increase satisfaction and good vaginal penetration (time frame: 6 MOTHES). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.