Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

NCT07293156 | Recruiting

• 1 other identifier: Pilate Exercises for DED2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

Diabete Mellitus; Erectile dysfunction; Pilates exercises; Pelvic floor exercises

Outcome Measures

Primary Outcomes (1)

• penile perfusion

  Colour-coded duplex sonography (5-10 MHz probes) will be used for the evaluation of penile perfusion. Half ml of a vasoactive agent (trimix solution) will be injected into the corpus cavernosum. The systolic and diastolic velocities (cm/s) will be performed at 10 and 30 min for both cavernous artery. Re-dosing with 0.5 ml of trimax solution will be performed for patients who did not achieve adequate hardness. The highest values obtained will be recorded. The following Doppler indices of the right and left cavernous arteries: peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistance index (RI) will be recorded.

  Base line and after 12 weeks

Secondary Outcomes (1)

• International Index of Erectile Function-5 (IIEF-5) scale.

  Baseline and after 12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

study group

Other: Pilate Exercises; Other: Pelvic floor muscles exercises

Active comparator

ACTIVE COMPARATOR

control

Other: Pelvic floor muscles exercises

Interventions

Pilate Exercises OTHER

Pilates protocol that will be used in the present study consisted of 11 different Pilates postures: Pilates Breathing, Spine Stretch, Swan, Shoulder Bridge, Hundreds, Double Leg Stretch, Footwork, Roll up, Single Leg Stretch, Leg Pull Back, Kick front and back. It will be performed thrice a week, with each session lasting 60 minutes, for 12 weeks, totaling 36 sessions. The progression of the exercises will be based on increasing the number of repetitions of the exercise, and variations in posture from beginner to intermediate and advanced, for each exercise. The movements will be repeated six to eight times each.

Experimental

Pelvic floor muscles exercises OTHER

The pelvic floor exercises will be taught by a skilled physiotherapist who instructed the men to tighten their pelvic floor muscles as strongly as possible (as if to prevent flatus from escaping), to gain muscle hypertrophy. During pelvic floor muscle training attention was placed on the ability to retract the penis and lift the scrotum, to make sure the bulbocavernosus and ischiocavernosus muscles were working strongly. Emphasis was placed on gaining a few maximum contractions (three when lying, three sitting, and three standing) twice daily rather than prolonged repetitions. Some submaximal pelvic floor work will be advised while walking, to increase muscle endurance. Men will be also taught to tighten their pelvic floor muscles strongly after voiding urine whilst still poised over the toilet, as a way of working the bulbocavernosus muscle to eliminate the urine from the bulbar urethra. Frequency of treatment: Treatment will be given 3 times / week for 12 weeks total of 36 session

Active comparator; Experimental

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Males with diabetic erectile dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 40-60 years.
• Diagnosed diabetes mellitus (type 2) ≥ 1 year.
• Clinical diagnosis of erectile dysfunction for ≥ 6 months, confirmed by IIEF5 score.
• Stable antidiabetic medications for ≥ 3 months prior to randomization.
• HbA1c between 6.5% and 10.0%.
• Sexually active or attempting sexual activity at least occasionally (at least once monthly) and willing to attempt intercourse during study.
• Able and willing to participate in the exercise program (physically capable and available for scheduled sessions) and provide written informed consent.

You may not qualify if:

• Severe cardiovascular disease within past 6 months (e.g., recent myocardial infarction, unstable angina, decompensated heart failure, uncontrolled arrhythmia) that contraindicates exercise.
• Uncontrolled hypertension (e.g., systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg) despite treatment.
• Severe peripheral vascular disease or other conditions preventing safe exercise (severe claudication, severe orthopedic limitations).
• History of pelvic surgery or pelvic radiation within the last 12 months that could acutely affect erectile function.
• Primary neurogenic causes of ED unrelated to diabetes (spinal cord injury, multiple sclerosis).
• Major psychiatric illness or severe cognitive impairment interfering with consent/compliance .
• Current substance abuse or heavy alcohol use that could affect sexual function or compliance.
• Severe hypogonadism requiring imminent testosterone therapy (total testosterone \< 8 nmol/L with symptoms).
• Active genitourinary infection or untreated severe sexual dysfunction disorders other than ED.
• Use of medications known to cause ED that cannot be discontinued or stabilized.
• Current participation in structured pelvic floor or sexual-function exercise program similar to the intervention.
• Recent (within 4 weeks) or planned changes in PDE5i therapy.
• Any medical condition making participation unsafe or likely to confound outcomes per investigator judgment.

Sponsors & Collaborators

• Benha University: lead
• Ahram Canadian University: collaborator

Study Sites (2)

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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

CONTACT

01096968910; mahmoud.mohamed@fpt.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) This is a parallel group randomized controlled trial with two arms receiving different interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: Interventional

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (2)