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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction; Premature Ejaculation; Pelvic Floor; Weak; Premature (Early) Ejaculation
• Intervention / Treatment: Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Héctor Corredor, MD; Phone Number: +573174317162; Email: hcorredor@bostonmedical.com.co
• Study Contact Backup: Name: Carolina Sandoval, Master; Phone Number: +573133920816; Email: csandoval@bostonmedical.com.co

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 11022
      • Recruiting
      • Boston Medical Group Colombia
      • Contact: Carolina Sandoval, Master; Phone Number: 57 3208899777; Email: csandoval@bostonmedical.com.co
      • Contact: Héctor Corredor, MD; Phone Number: +57 3174317162; Email: hcorredor@bostonmedical.com.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erectile Dysfunction; The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity. For muscular hypoactivity: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24 For muscular hyperactivity they will be given: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation	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: Device: Electrical stimulation; Muscular proprioceptive work: 50 Hz 300 µs
Experimental: Premature Ejaculation; Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation	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: Device: Electrical stimulation; Muscular proprioceptive work: 50 Hz 300 µs
Experimental: Premature Ejaculation + Erectile Dysfunction; Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation	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: Device: Electrical stimulation; Muscular proprioceptive work: 50 Hz 300 µs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline intravaginal latency time (IVLT)	Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)	12 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
Side Effects	Incidente of side effects related to therapy.	12 weeks, 3 and 6 months follow-up.
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.
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.

Collaborators and Investigators

• Sponsor: Boston Medical Group
• Investigators: Principal Investigator: Cristina Amaya, Boston Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Ejaculatory Dysfunction; Premature Birth; Erectile Dysfunction; Premature Ejaculation
• Other Study ID Numbers: BMGC-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes