Diabete Mellitus, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Pilates Exercise, Pelvic Floor Muscle 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.
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
Sponsors
Ahram Canadian University
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single (Participant) 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
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.
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 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. |
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
Contacts
Primary ContactMahmoud Hamada Mohamed Associate Professor, Ph.D
Outcome results
None listed