Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

NCT07293156 | Completed

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

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

  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

Other: Pilate Exercises; Other: Home based pelvic floor muscle training; Drug: Sildenafil therapy

Active comparator

ACTIVE COMPARATOR

Other: Home based pelvic floor muscle training; Drug: Sildenafil therapy

Interventions

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.

Active comparator; Experimental

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.

Active comparator; Experimental

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

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, Egypt

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor blinded 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: June 22, 2026
• Study Completion: June 23, 2026
• Last Updated: June 25, 2026

Record last verified: 2025-12

Locations

EG (1)