Clinical trial NCT06425211: Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
Official title: Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Premature (Early) Ejaculation
Premature Ejaculation
Pelvic Floor; Weak
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

Overall:

* Men over 18 years of age
* Erectile dysfunction or premature ejaculation for at least 6 months
* Sexual activity with a heterosexual partner at least once a week
* Signing of informed consent before the start of the study

For the premature ejaculation group:

* Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
* Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11

For the erectile dysfunction group:

* Clinical diagnosis of primary erectile dysfunction
* International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26

Exclusion Criteria:

* Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
* Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
* History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
* History of pelvic radiotherapy
* Pacemaker or cardiac arrhythmia, epilepsy
* History of spinal cord trauma or spinal surgeries.
* Inability to attend therapies or controls
* Illiteracy or cognitive disability that prevents you from completing the questionnaires
* Psychiatric, psychological disorders, or cognitive deficiencies
* Injuries in the area of application of the therapy
* Active pelvic organ cancer

Primary outcomes:
measure: Change in baseline intravaginal latency time (IVLT)
timeFrame: 12 weeks
measure: Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in baseline intravaginal latency time (IVLT) at follow-up
timeFrame: 3 and 6 months of follow-up.
measure: Change Premature Ejaculation Perfil (PEP) score
timeFrame: 12 weeks, 3 and 6 months follow-up.
measure: Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score
timeFrame: 12 weeks, 3 and 6 months follow-up.
measure: Change Intracavity Assessment
timeFrame: 12 weeks, 3 and 6 months follow-up.
measure: Side Effects
timeFrame: 12 weeks, 3 and 6 months follow-up.
measure: Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up
timeFrame: 3 and 6 months of follow-up.
measure: Change in Erection Hardness Score (EHS)
timeFrame: 12 weeks, 3 and 6 months of follow-up.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Boston Medical Group Colombia
state: Cundinamarca
Study officials:
affiliation: Boston Medical Group
name: Cristina Amaya
role: PRINCIPAL_INVESTIGATOR
References: