Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04059341
Other study ID # ELIESWTEDRP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date July 1, 2020

Study information

Verified date August 2019
Source Odense University Hospital
Contact Ali Moumneh, BSC.med
Phone +45234826423
Email almou15@student.sdu.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date July 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Radically prostatectomised men

- Non nerve-sparing or nerve-sparing RP.

- Age 20-80 years

- Have been in a relationship for more than 3 months.

- Sexually active

- Patient can give informed consent.

Exclusion Criteria:

- Men with ED of neuropathological or psychogenic origin

- Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.

- Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.

Study Design


Intervention

Device:
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary IIEF-5 Score 1 Change in International Index of Erectile Function (IIEF-5) score compared to baseline One month after final treatment session
Primary IIEF-5 Score 3 Change in International Index of Erectile Function (IIEF-5) score compared to baseline Three months after final treatment session
Primary IIEF-5 Score 6 Change in International Index of Erectile Function (IIEF-5) score compared to baseline Six months after final treatment session
Secondary EDITS Erectile Dysfunction Inventory of Treatment Satisfaction score One month after final treatment session
Secondary RigiScan Change in nocturnal erections compared to baseline One month after final treatment session
Secondary EHS 1 Change in Erection Hardness Score compared to baseline One month after final treatment session
Secondary EHS 3 Change in Erection Hardness Score compared to baseline Three months after final treatment session
Secondary EHS 6 Change in Erection Hardness Score compared to baseline Six months after final treatment session
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3