Pilates for erectile dysfunction in men with type 2 diabetes

Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

This study will test whether a Pilates-based exercise program helps men aged 40–60 with type 2 diabetes who have erectile dysfunction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 60 Years
• Sex: Male
• Sponsor: Benha University (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Banhā, Benha and 1 other locations)
• Trial ID: NCT07293156 on ClinicalTrials.gov

What this trial studies

This is a controlled interventional trial enrolling 60 men with type 2 diabetes and erectile dysfunction, allocated to a Pilates exercise program or pelvic floor muscle exercise group (30 per group). Participants are recruited from Benha University Hospital and affiliated outpatient clinics in Benha and Giza, Egypt, and will undergo baseline and follow-up assessments including the IIEF-5 questionnaire. The intervention emphasizes ground-based Pilates movements that recruit pelvic floor muscles and compares them with conventional pelvic floor training. Outcomes focus on changes in erectile function and related patient-reported measures over the study period.

Who should consider this trial

Good fit: Men aged 40–60 with type 2 diabetes for at least one year, erectile dysfunction for six months or more confirmed by IIEF-5, HbA1c between 6.5% and 10.0%, and stable antidiabetic medications are the intended participants.

Not a fit: Men with severe diabetes-related nerve damage, advanced vascular disease, or other causes of refractory erectile dysfunction may not experience meaningful benefit from exercise alone.

Why it matters

Potential benefit: If successful, the program could offer a low-risk, non-drug option to improve erectile function and sexual satisfaction for some men with diabetes.

How similar studies have performed: There are no published trials specifically testing Pilates for diabetic erectile dysfunction, though pelvic floor muscle training has shown benefit for erectile dysfunction in some non-diabetic populations.

Eligibility criteria

Inclusion Criteria:

1. Men aged 40-60 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.

Where this trial is running

Banhā, Benha and 1 other locations

• Outpatient clinic, faculty of Physical Therapy, Benha university — Banhā, Benha, Egypt (Recruiting)
• Outpatient clinic, faculty of Physical Therapy, Ahram Canadian university — Giza, Giza Governorate, Egypt (Withdrawn)

Study contacts

• Study coordinator: Mahmoud Hamada Mohamed Associate Professor, Ph.D

Conditions Diabete Mellitus; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Pilates Exercise; Pelvic Floor Muscle Exercise; Erectile dysfunction; Pilates exercises; Pelvic floor exercises