Male Pelvic Floor Muscle Rehabilitation Exercises

NCT07451808 | Not Yet Recruiting

• 1 other identifier: G128
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase I G128 Study Objective The ischiocavernosus (IC) and bulbospongiosus (BS) muscles are vital components of the superficial perineal layer, serving as the foundation for male sexual health and performance. These muscles play a primary role in achieving and maintaining erections by compressing the veins to trap blood within the erectile tissues. Furthermore, they are responsible for the rhythmic contractions necessary for ejaculation and the physiological sensations associated with orgasm. Beyond their role in sexual function, these muscles provide critical structural support to the pelvic floor and assist in urinary control. By working in tandem, the IC and BS muscles ensure penile rigidity while stabilizing the surrounding pelvic structures. Maintaining the strength and coordination of these muscles is essential for overall reproductive health and the prevention of pelvic floor dysfunction. The primary objective of this clinical trial is to evaluate the clinical efficacy and therapeutic potential of Exercise G128 in strengthening the male pelvic floor musculature. Furthermore, the study aims to establish a comprehensive safety profile for Exercise G128 during active participation. The research seeks to address the following core investigative questions: To what extent does Exercise G128 improve the tonicity and contractile strength of the IC and BS muscles? What is the incidence and nature of adverse medical events or physiological stressors reported by participants while performing the Exercise G128 protocol? Researchers will conduct a comparative analysis, benchmarking the physiological outcomes of Exercise G128 against existing clinical data regarding the efficacy of traditional Kegel exercises. Participant Requirements: Adhere to a structured regimen, performing Exercise G128 four times weekly over a one-month intervention period. Attend bi-weekly telehealth consultations via video conferencing for supervised clinical assessments, progress monitoring, and physiological testing. Maintain a detailed daily log documenting functional progress, as well as any instances of physical exertion or soreness that necessitated a temporary cessation of the exercise protocol.

Conditions

Erectile Dysfunction; Urinary Incontinence; Premature Ejaculation

Keywords

Dripping or leakage; urinary incontinence; Kegel exercises for men; ischiocavernosus muscle; bulbospongiosus muscle; Erectile dysfunction (ED); Premature ejaculation

Outcome Measures

Primary Outcomes (2)

• This study aims to compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.

  From enrollment to the end of treatment at 4 weeks.

• Proportion of Patients Achieving Quantifiable Improvements in Pelvic Floor Muscle Strength Following a One-Month Treatment Protocol.

  From enrollment to the end of treatment at 4 weeks.

Study Arms (1)

G128 #1

EXPERIMENTAL

Other: Male Pelvic Floor Rehabilitation #1

Interventions

Male Pelvic Floor Rehabilitation #1 OTHER

Execute the G128 exercise for four consecutive days, followed by a scheduled three-day recovery period. This specific training cycle should be repeated consistently over a 30-day duration to achieve optimal results. Maintaining this frequency ensures a proper balance between physical exertion and necessary muscle repair.

G128 #1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men 18 - 60 years of age
• Must be able to achieve an erection

You may not qualify if:

• Underlying medical conditions or poor health
• Men who fall within the obese category based on standard body mass index (BMI) measurements

Sponsors & Collaborators

• Dream Video LLC: lead
• Dream Holdings Research: collaborator

MeSH Terms

Conditions

Erectile Dysfunction; Urinary Incontinence; Premature Ejaculation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ejaculatory Dysfunction

Central Study Contacts

Matthew Quitto II

CONTACT

9173422895; dream@dreamholdingsllc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR