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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425211
• Other study ID #: BMGC-6
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Boston Medical Group
• Contact: Carolina Sandoval, Master
• Phone: +573133920816
• Email: csandoval[@]bostonmedical.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Pelvic Floor; Weak
• Premature Birth
• Premature Ejaculation

Intervention

Behavioral:
• Therapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.

Device:
• Perineal electromyographic biofeedback
Free muscle work and gross motor coordination:
• Electrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs

Locations

Country	Name	City	State
Colombia	Boston Medical Group Colombia	Bogotá	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Group

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline intravaginal latency time (IVLT)	Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)	12 weeks
Primary	Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score	International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)	12 weeks
Secondary	Change in baseline intravaginal latency time (IVLT) at follow-up	Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)	3 and 6 months of follow-up.
Secondary	Change Premature Ejaculation Perfil (PEP) score	Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)	12 weeks, 3 and 6 months follow-up.
Secondary	Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score	Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)	12 weeks, 3 and 6 months follow-up.
Secondary	Change Intracavity Assessment	Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.	12 weeks, 3 and 6 months follow-up.
Secondary	Side Effects	Incidente of side effects related to therapy.	12 weeks, 3 and 6 months follow-up.
Secondary	Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up	International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3)	3 and 6 months of follow-up.
Secondary	Change in Erection Hardness Score (EHS)	Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3)	12 weeks, 3 and 6 months of follow-up.