Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425224
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Sponsor:
Boston Medical Group
Organization:
Boston Medical Group
Study Overview
Official Title:
Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation Phase III Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENSPE2
Brief Summary:
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation The main question to answer is
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation compared to standard pharmacological treatment with dapoxetine
Patients will
Be randomized in acontrolled clinical trial Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included
Be assigned by randomization to one of three treatment groups
Group 1 Tens therapy dapoxetine placebo on demand
Group 2 Standard treatment dapoxetine 30 mg as needed placebo therapy
Group 3 Tens therapy standard treatment dapoxetine 30 mg as needed
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation compared to standard pharmacological treatment with dapoxetine
Patients will
Be randomized in acontrolled clinical trial Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included
Be assigned by randomization to one of three treatment groups
Group 1 Tens therapy dapoxetine placebo on demand
Group 2 Standard treatment dapoxetine 30 mg as needed placebo therapy
Group 3 Tens therapy standard treatment dapoxetine 30 mg as needed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None