Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT07293156
Eligibility Criteria:
Inclusion Criteria:
1. Men aged 20-60 years.
2. Diagnosed diabetes mellitus (type 2) ≥ 1 year.
3. Clinical diagnosis of erectile dysfunction for ≥ 6 months, confirmed by IIEF5 score.
4. Stable antidiabetic medications for ≥ 3 months prior to randomization.
5. HbA1c between 6.5% and 10.0%.
6. Sexually active or attempting sexual activity at least occasionally (at least once monthly) and willing to attempt intercourse during study.
7. Able and willing to participate in the exercise program (physically capable and available for scheduled sessions) and provide written informed consent.
Exclusion Criteria:
1. Severe cardiovascular disease within past 6 months (e.g., recent myocardial infarction, unstable angina, decompensated heart failure, uncontrolled arrhythmia) that contraindicates exercise.
2. Uncontrolled hypertension (e.g., systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg) despite treatment.
3. Severe peripheral vascular disease or other conditions preventing safe exercise (severe claudication, severe orthopedic limitations).
4. History of pelvic surgery or pelvic radiation within the last 12 months that could acutely affect erectile function.
5. Primary neurogenic causes of ED unrelated to diabetes (spinal cord injury, multiple sclerosis).
6. Major psychiatric illness or severe cognitive impairment interfering with consent/compliance .
7. Current substance abuse or heavy alcohol use that could affect sexual function or compliance.
8. Severe hypogonadism requiring imminent testosterone therapy (total testosterone \< 8 nmol/L with symptoms).
9. Active genitourinary infection or untreated severe sexual dysfunction disorders other than ED.
10. Use of medications known to cause ED that cannot be discontinued or stabilized.
11. Current participation in structured pelvic floor or sexual-function exercise program similar to the intervention.
12. Recent (within 4 weeks) or planned changes in PDE5i therapy.
13. Any medical condition making participation unsafe or likely to confound outcomes per investigator judgment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT07293156
Study Brief:
Protocol Section:
NCT07293156