Actively Recruiting

Phase Not Applicable
Age: 40Years - 60Years
MALE
NCT07293156

Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

Led by Benha University · Updated on 2026-04-06

60

Participants Needed

2

Research Sites

28 weeks

Total Duration

On this page

Sponsors

B

Benha University

Lead Sponsor

A

Ahram Canadian University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

Who Can Participate

Age: 40Years - 60Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 40-60 years
  • Diagnosed with type 2 diabetes mellitus for at least 1 year
  • Clinical diagnosis of erectile dysfunction for at least 6 months confirmed by IIEF5 score
  • Stable antidiabetic medications for at least 3 months before study start
  • HbA1c level between 6.5% and 10.0%
  • Sexually active or attempting sexual activity at least once monthly and willing to attempt intercourse during study
  • Physically able and willing to participate in the exercise program and provide written informed consent
Not Eligible

You will not qualify if you...

  • Severe cardiovascular disease within the past 6 months contraindicating exercise
  • Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg) despite treatment
  • Severe peripheral vascular disease or conditions preventing safe exercise
  • Pelvic surgery or radiation within the last 12 months affecting erectile function
  • Primary neurogenic causes of erectile dysfunction unrelated to diabetes
  • Major psychiatric illness or severe cognitive impairment interfering with consent or compliance
  • Current substance abuse or heavy alcohol use affecting sexual function or compliance
  • Severe hypogonadism requiring imminent testosterone therapy (total testosterone <8 nmol/L with symptoms)
  • Active genitourinary infection or untreated severe sexual dysfunction disorders other than ED
  • Use of medications causing ED that cannot be discontinued or stabilized
  • Participation in structured pelvic floor or sexual-function exercise programs similar to the intervention
  • Recent or planned changes in PDE5 inhibitor therapy within 4 weeks
  • Any medical condition making participation unsafe or likely to confound outcomes as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, Egypt

Actively Recruiting

2

Outpatient clinic, faculty of Physical Therapy, Ahram Canadian university

Giza, Giza Governorate, Egypt

Withdrawn

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Research Team

M

Mahmoud Hamada Mohamed Associate Professor, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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