Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).
This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A)
sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total).
Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then
undergo a 4 week washout period without erectogenic aids, and return for a 28-week
evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be
offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1).
Random assignment will be performed by computer program (eg. randomizer.org), in a design
that obtains equal sample size per group.
All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes
evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile
length, urinary incontinence, and oncologic status.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05735223 -
A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
|
N/A | |
| Recruiting |
NCT05868668 -
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
|
N/A | |
| Completed |
NCT03241758 -
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy
|
N/A | |
| Recruiting |
NCT05558007 -
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
|
Phase 2 | |
| Completed |
NCT05332340 -
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
|
Phase 1 | |
| Completed |
NCT04491773 -
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months
|
||
| Recruiting |
NCT05650866 -
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
|
N/A | |
| Not yet recruiting |
NCT06126874 -
Additional Effects of Aerobic and Resistance Exercises to Pelvic Floor Muscle Training After Radical Prostatectomy
|
N/A | |
| Completed |
NCT05772598 -
Validating the 'Sexual Minorities and Prostate Cancer Scale' to Gold Standard Questionnaires
|
||
| Recruiting |
NCT05244486 -
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
|
N/A | |
| Not yet recruiting |
NCT06458855 -
Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy
|
N/A | |
| Completed |
NCT00335634 -
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
|
N/A | |
| Recruiting |
NCT03862599 -
Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
|
N/A | |
| Active, not recruiting |
NCT04434352 -
Low Intensity Shockwave Therapy for Erectile Dysfunction
|
N/A | |
| Completed |
NCT04164355 -
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg
|
||
| Not yet recruiting |
NCT05960149 -
Use of Indocyanine Green in Robotic Prostate Surgeries
|
Phase 4 | |
| Terminated |
NCT01996852 -
Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
|
N/A | |
| Recruiting |
NCT06076850 -
Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
|
N/A | |
| Terminated |
NCT01770340 -
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
|
Phase 4 | |
| Not yet recruiting |
NCT05578157 -
MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
|