Impact of Pilates Exercises on Diabetic Erectile Dysfunction. (PilatesDED2025)

Benha University

Status: Enrolling

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

Treatments: Other: Pelvic floor muscles exercises; Other: Pilate Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07293156

Pilate Exercises for DED2025

Details and patient eligibility

About

Erectile dysfunction (ED) has a prevalence of 52.5% in diabetic male patients, as described in a meta-analysis of 145 studies, including 88,577 men with type 1 and type 2 diabetes.

In men, ED can cause sexual dissatisfaction and distress, unsatisfactory relationships, and marital tension

Full description

Pilates emerged as a method of rehabilitation during World War I, when Joseph Hubertus Pilates applied his knowledge to rehabilitate injured men. The popularity of the method grew most in the 1980. More recently, Pilates has been used resulting in improved fitness (flexibility, strength and balance) and body consciousness. The method features ground-based exercises created by Joseph Pilates.

Because most Pilates exercises are performed in conjunction with the recruitment of PF muscle fibres, many Pilates instructors believe that the method can produce a significant increase in the force or contractility of the muscles. Furthermore, if Pilates promotes an improvement in the functioning of the pelvic floor muscles (PFM), it may be an alternative for the treatment and prevention of pelvic floor dysfunction.

Up till now, no published trials about impact of Pilate exercises on diabetic erectile dysfunction.

A total of 60 patients (n=30 per group), diagnosed with diabetic erectile dysfunction in the past 6 months. Participants will be recruited from Benha University hospital and local andrology and urology clinics in benha and giza . Participants will be screened for eligibility prior to being enrolled in the study participating in the study assessments.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental

Experimental group

Description:

study group

Treatment:

Other: Pilate Exercises

Other: Pelvic floor muscles exercises

Active comparator

Active Comparator group

Description:

control

Treatment:

Other: Pelvic floor muscles exercises