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Completed

NCT Number: NCT07293156

Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

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

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Erectile Dysfunction Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pelvic Floor Muscle Exercise Pilates Exercise Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men aged 40-60 years.
  • Married.
  • Diagnosed with type 2 diabetes mellitus for >5 years, with initial diagnosis confirmed by HbA1c >6.5%.
  • Arteriogenic erectile dysfunction (ED) of >6 months' duration, confirmed by penile Doppler ultrasonography showing peak systolic velocity (PSV) of the cavernosal arteries <25 cm/s.
  • Body mass index (BMI) <30 kg/m².

Exclusion criteria

  • Poorly controlled diabetes mellitus (HbA1c >9%).
  • Neurogenic, venogenic, or psychogenic ED.
  • Cardiac conditions contraindicating sexual activity.
  • Neurological disorders or spinal cord injury.
  • Alcohol abuse or illicit drug use.
  • Chronic hematological disorders.
  • Active genitourinary infection.
  • Severe hypogonadism.
  • History of radical prostatectomy, pelvic surgery, or pelvic trauma.
  • Penile prosthesis implantation.
  • Current or previous participation in a structured pelvic floor muscle training or sexual rehabilitation program.

Treatment and study plan

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.

Home based pelvic floor muscle training

Other

Participants will attend an educational session conducted by a physiotherapist on pelvic floor anatomy, the physiology of erection, and the roles of the ischiocavernosus and bulbocavernosus muscles in erectile function. They will be instructed on proper pelvic floor muscle contraction by simulating the interruption of urine flow and performing maximal voluntary contractions. A home-based PFMT program will be prescribed. Exercises will initially be performed in the supine position with knees flexed and subsequently progressed to sitting or standing positions as tolerated. Participants will be instructed to perform PFMT twice daily (morning and evening), consisting of 15 short contractions (1 second each) and 15 sustained contractions (6-10 seconds each). Adherence will be monitored through a mobile messaging application, where participants will report completion of daily exercises and receive reminders when necessary.

Sildenafil therapy

Drug

Participants will receive sildenafil citrate 25 mg orally once daily and sildenafil citrate 50 mg orally on demand, taken approximately 1 hour before sexual intercourse, throughout the study period.

Primary outcomes

  1. penile perfusion

    Time frame: Base line and after 12 weeks

    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 Doppler indices of the right and left cavernous arteries: peak systolic velocity (PSV)

Secondary outcomes

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

    Time frame: Baseline and after 12 weeks

    The IIEF-5 scale is used to assess patients with erectile dysfunction to determine the extent of the erectile function in patients. The full-scale 15-item version has five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction.

    The shortened 5-item version is on a scale of 5 to 25:

    22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Acronym: PilatesDED2025

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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