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Not yet recruiting NCT07451808

Male Pelvic Floor Muscle Rehabilitation Exercises

No phase Interventional Erectile Dysfunction Urinary Incontinence Premature Ejaculation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Male Pelvic Floor Rehabilitation #1.
Who it may be relevant to
Registry conditions: Erectile Dysfunction, Urinary Incontinence, Premature Ejaculation. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Male Pelvic Floor Muscle Rehabilitation (Kegel Exercises) Pelvic Floor Muscle Training

Overview

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.

Detailed description

G128 Study Objective

The primary purpose of this clinical investigation is to evaluate the physiological efficacy of the targeted G128 exercise protocol in enhancing the structural integrity and contractile strength of the pelvic floor musculature. This study specifically aims to measure hypertrophy and functional improvements within the Ischiocavernosus and Bulbospongiosus muscles following a standardized training period. By establishing these metrics, the research seeks to validate the protocol's impact on core pelvic stability.

Utilizing quantitative assessment tools, this research will determine whether the G128 regimen yields a statistically significant increase in pelvic muscle tone and endurance compared to baseline measurements. The findings may support the implementation of this regimen as a viable, non-invasive therapeutic intervention for patients experiencing various forms of pelvic floor dysfunction. Ultimately, the study strives to provide a data-driven foundation for advanced rehabilitative practices.

Interventions

  • Other Male Pelvic Floor Rehabilitation #1
    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.

Primary outcome measures

  • This study aims to compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes. [Time frame: 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. [Time frame: From enrollment to the end of treatment at 4 weeks.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07451808 · G128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗