Impact of Pilate Exercises on Diabetic Erectile Dysfunction.
NCT ID: NCT07293156
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-15
2026-06-30
Brief Summary
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In men, ED can cause sexual dissatisfaction and distress, unsatisfactory relationships, and marital tension
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental
study group
Pilate 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.
Pelvic floor muscles exercises
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
control
Pelvic floor muscles exercises
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
Interventions
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Pilate 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.
Pelvic floor muscles exercises
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
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
60 Years
MALE
No
Sponsors
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Ahram Canadian University
OTHER
Benha University
OTHER
Responsible Party
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Mahmoud Hamada Mohamed
Associate Professor of Physical Therapy
Locations
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Outpatient clinic, faculty of Physical Therapy, Benha university
Banhā, Benha, Egypt
Outpatient clinic, faculty of Physical Therapy, Ahram Canadian university
Giza, Giza Governorate, Egypt
Countries
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Central Contacts
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Mahmoud Hamada Mohamed Associate Professor, Ph.D
Role: CONTACT
Phone: 01096968910
Email: [email protected]
Facility Contacts
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Mahmoud Hamada Mohamed Associate Professor, Ph.D
Role: primary
Ahmed Mounir Salama Associate Professor, Ph.D
Role: backup
Mohamed Mahmoud Dogha, Assistant Professor of Urology
Role: primary
Other Identifiers
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Pilate Exercises for DED2025
Identifier Type: -
Identifier Source: org_study_id