Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543628
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tadalafil Combined With Low-Energy Pulsed Ultrasound Lipus for the Treatment of Erectile Dysfunction A Prospective Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound LIPUS in patients with erectile dysfunction ED through a randomized controlled trial
Detailed Description:
Erectile dysfunction ED is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months Low-intensity pulsed ultrasound LIPUS a non-invasive therapy improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue blood vessels and cavernous nerves as well as reducing inflammation
This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 11 ratio The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks followed by a 4-week interval without LIPUS treatment and then repeat the treatment The control group will receive only daily 5mg tadalafil
Efficacy will be evaluated primarily through the minimal clinically important difference MCID of the International Index of Erectile Function-5 IIEF-5 at each follow-up point combined with Erectile Hardness Score EHS penile blood flow parameters and elasticity values for comprehensive assessment
This trial may provide additional clinical evidence for the efficacy safety and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment providing new methods for efficacy evaluation
This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 11 ratio The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks followed by a 4-week interval without LIPUS treatment and then repeat the treatment The control group will receive only daily 5mg tadalafil
Efficacy will be evaluated primarily through the minimal clinically important difference MCID of the International Index of Erectile Function-5 IIEF-5 at each follow-up point combined with Erectile Hardness Score EHS penile blood flow parameters and elasticity values for comprehensive assessment
This trial may provide additional clinical evidence for the efficacy safety and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment providing new methods for efficacy evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None