AzTrials
AzTrials

Erectile DysfunctionNCT07451808

Male Pelvic Floor Muscle Rehabilitation Exercises

A study testing Male Pelvic Floor Rehabilitation #1 in people with Erectile Dysfunction and Urinary Incontinence, run by Dream Video LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
What is being tested?
Male Pelvic Floor Rehabilitation #1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Dec 2026to Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Matthew Quitto II contact

9173422895

dream@dreamholdingsllc.com

About this study

Official title: Male Pelvic Floor Muscle Rehabilitation (Kegel Exercises) Pelvic Floor Muscle Training

Phase I

G128 Study Objective

Read more

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.

UPDATE:

The G128 inventor and user scheduled an appointment with a Certified Pelvic Rehab Practitioner, who has over 10 years of experience treating complex diagnoses and pelvic impairments. During the appointment, a male pelvic floor muscle test was performed using Rehabilitative Ultrasound Imaging (RUSI).

Ultrasound Findings (suprapubic RUSI): Muscle bulk is visually above average compared to clinician's clinical experience; good bilateral muscle mass noted with asymmetry as described.

Voluntary Contraction / Coordination: Patient demonstrated visible pelvic floor lift on ultrasound with volitional kegel contraction.

Contraction quality: good lift observed; clinician noted contraction quality as above average relative to clinical experience.

Read the 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.

Being tested
Male Pelvic Floor Rehabilitation #1
Keywords
Dripping or leakage, urinary incontinence, Kegel exercises for men, ischiocavernosus muscle, bulbospongiosus muscle, Erectile dysfunction (ED), Premature ejaculation
Medical subject headings
Erectile Dysfunction, Urinary Incontinence, Premature Ejaculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Male Pelvic Floor Rehabilitation #1Other

    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.

Study groups in NCT07451808
Study groupRoleWhat they receive
G128 #1ExperimentalNot described
Receives: Other: Male Pelvic Floor Rehabilitation #1

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From enrollment to the end of treatment at 4 weeks.

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

    Measured: From enrollment to the end of treatment at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451808
Sponsor's protocol ID
G128
Status last verified
Oct 2026
First submitted
28 Feb 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The deidentified individual participant data underlying the results reported in this article will be made available for research purposes. This data sharing period will commence 9 months after the date of publication and will conclude 36 months following the article's release. This timeline ensures sufficient time for primary analysis while promoting transparency and collaborative scientific inquiry. Researchers interested in accessing the data should submit a formal proposal to dream@dreamholdingsllc.com. All requests will be subject to a rigorous review process conducted by an independent committee to ensure the scientific merit and ethical integrity of the proposed study. Approved scientists will be required to sign a data use agreement before any information is transmitted.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in