Diabete Mellitus, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Pelvic Floor Muscle Exercise, Pilates Exercise
Conditions
Keywords
Diabete Mellitus, Erectile dysfunction, Pilates exercises, Pelvic floor exercises
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
Detailed 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.
Interventions
OTHERPilate Exercises
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.
OTHERHome based pelvic floor muscle training
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.
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor blinded This is a parallel group randomized controlled trial with two arms receiving different interventions.
Intervention model description
Interventional
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| penile perfusion | 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
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function-5 (IIEF-5) scale. | 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 |
Countries
Egypt
Outcome results
None listed