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.
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
- Conditions the study is for
- Erectile Dysfunction, Urinary Incontinence, Premature Ejaculation
- 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.
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 group | Role | What they receive |
|---|---|---|
| G128 #1 | Experimental | Not 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.
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.
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.
- First posted5 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dream Video LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Dream Holdings Research
- Responsible party
- Sponsor
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.