Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

Phase

N/A

Condition

Infertility

Male Hormonal Deficiencies/abnormalities

Premature Ejaculation

Treatment

Electrical stimulation

Therapeutic exercises

Perineal electromyographic biofeedback

Clinical Study ID

NCT06425211

BMGC-6

Ages 18-100
Male

Study 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.

Eligibility Criteria

Inclusion

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) scoreless than 26

Exclusion

Exclusion Criteria:

Pharmacological treatment for erectile dysfunction or premature ejaculation in thelast 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 thequestionnaires
Psychiatric, psychological disorders, or cognitive deficiencies
Injuries in the area of application of the therapy
Active pelvic organ cancer

Study Design

Electrical stimulation

October 30, 2021

December 31, 2026

Study Description

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.

Connect with a study center

Boston Medical Group Colombia
Bogotá, Cundinamarca 3685413 11022
Colombia
Active - Recruiting

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