Diabete MellitusPilatesDED2025NCT07293156
Impact of Pilates Exercises on Diabetic Erectile Dysfunction.
A study testing Pilate Exercises, Home based pelvic floor muscle training and Sildenafil therapy in people with Diabete Mellitus and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Benha University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Diabete Mellitus, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Pilates Exercise
- What is being tested?
- Pilate Exercises, Home based pelvic floor muscle training and Sildenafil therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 23 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, faculty of Physical Therapy, Benha university
Banhā, Benha
About this study
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
Read the 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.
- Conditions
- Diabete Mellitus, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Pilates Exercise, Pelvic Floor Muscle Exercise
- Being tested
- Pilate Exercises, Home based pelvic floor muscle training, Sildenafil therapy
- Keywords
- Diabete Mellitus, Erectile dysfunction, Pilates exercises, Pelvic floor exercises
- Medical subject headings
- Diabetes Mellitus, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilate ExercisesOther
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 trainingOther
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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Pilate Exercises; Other: Home based pelvic floor muscle training; Drug: Sildenafil therapy |
| Active comparator | Active comparator | Not described Receives: Other: Home based pelvic floor muscle training; Drug: Sildenafil therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Base line and after 12 weeks
Secondary outcomes (1)
International Index of Erectile Function-5 (IIEF-5) scale.
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
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Dec 2025
- Primary completion22 Jun 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamada Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293156
- Sponsor's protocol ID
- Pilate Exercises for DED2025
- Acronym
- PilatesDED2025
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pilates Exercises on Diabetic Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT07293156
- Acronym / sponsor ID
- PilatesDED2025 / Pilate Exercises for DED2025
- Conditions
- Diabete Mellitus, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Pilates Exercise, Pelvic Floor Muscle Exercise
- Keywords
- Diabete Mellitus, Erectile dysfunction, Pilates exercises, Pelvic floor exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilate ExercisesPilates 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. | Other | Experimental |
| Home based pelvic floor muscle trainingParticipants 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. | Other | Active comparator, Experimental |
| Sildenafil therapyParticipants 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. | Drug | Active comparator, Experimental |
Primary outcome
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)
1 secondary outcome
International Index of Erectile Function-5 (IIEF-5) scale.
Time frame: Baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilate Exercises, Home based pelvic floor muscle training and Sildenafil therapy in people with Diabete Mellitus and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
penile perfusion (time frame: Base line and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.