Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425211
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation
Sponsor:
Boston Medical Group
Organization:
Boston Medical Group
Study Overview
Official Title:
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation
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:
None
Brief Summary:
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation The main question to answer is
What is the effectiveness of pelvic floor therapy electrostimulation biofeedback and therapeutic exercise for the treatment of patients with erectile dysfunction and or premature ejaculation
Patients will
Have an initial consultation of pelvic floor rehabilitation before therapy
Be given pelvic floor therapy
Have a secondary consultation of pelvic floor rehabilitation after therapy
Three intervention groups will be included Group 1 Patients with premature ejaculation Group 2 Patients with erectile dysfunction Group 3 Patients with erectile dysfunction and premature ejaculation
What is the effectiveness of pelvic floor therapy electrostimulation biofeedback and therapeutic exercise for the treatment of patients with erectile dysfunction and or premature ejaculation
Patients will
Have an initial consultation of pelvic floor rehabilitation before therapy
Be given pelvic floor therapy
Have a secondary consultation of pelvic floor rehabilitation after therapy
Three intervention groups will be included Group 1 Patients with premature ejaculation Group 2 Patients with erectile dysfunction Group 3 Patients with erectile dysfunction and premature ejaculation
Detailed Description:
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation
Methodology Pre-post study Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy in three groups of patients independently
Group 1 Patients with premature ejaculation
Group 2 Patients with erectile dysfunction
Group 3 Patients with erectile dysfunction and premature ejaculation
66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks Outcomes will be evaluated at the end of therapy 12 weeks 3 and 6 months follow-up
Methodology Pre-post study Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy in three groups of patients independently
Group 1 Patients with premature ejaculation
Group 2 Patients with erectile dysfunction
Group 3 Patients with erectile dysfunction and premature ejaculation
66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks Outcomes will be evaluated at the end of therapy 12 weeks 3 and 6 months follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None