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Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients

Primary Purpose

Sexual Dysfunction, Shock Wave

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-intensity Shockwave Therapy
Kegel Exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction

Eligibility Criteria

35 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Erectile dysfunction due to Type 2 diabetes for at least six months . Age between 35-55 years. Exclusion Criteria: - 1. Venogenic ED 2. Poly neuropathy 3. Past radical prostatectomy or extensive pelvic surgery 4. Recovering from cancer in the past 5 years 5. Any unstable medical and psychiatric disorder. 6. Spinal cord injury and another neurological disease 7. Penile anatomical abnormalities. 8. Clinically significant chronic hematological disease. 9. Anti-androgens or radiotherapy treatment of pelvic region. 10. Patients with untreated hypogonadism. 11. Psychogenic ED (normal nocturnal penile tumescence parameters) 12. Cardiovascular conditions that prevent sexual activity (heart attack, stroke, or life-threatening arrhythmia within the previous 6 months. 13. Patient with penile prosthesis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Low-intensity Shockwave Therapy

    Kegel Exercises

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Penile color-coded Duplex scanning
    for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.
    International Index of Erectile Function (IIEF-EF) questionnaire
    At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058832
    Brief Title
    Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
    Official Title
    Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients. To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients. To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
    Detailed Description
    Erectile dysfunction (ED) is defined as the persistent inability to attain and maintain an erection enough to permit satisfactory sexual performance. Although ED is a benign disorder, it may affect physical and psychosocial health and may have a significant impact on the quality of life (QoL) of sufferers and their partners (Ruffo et al., 2015). According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction (ED) is defined as an inability to get or keep an erection firm enough for sexual intercourse due to diseases such as diabetes mellitus and atherosclerotic vascular occlusive disease (Stief et al., 2010). ED has been reported to occur in ≥50% of men with DM worldwide. It is usually present within 10 years of diagnosis of DM. The incidence of ED was reported to be higher in men with DM than for men without DM and up to 12% of men who present with ED were found to have previously undiagnosed DM (Johannes et al., 2000). Low-intensity extracorporeal shock wave therapy (Li-ESWT) was used in both in vitro and in vivo studies and the results showed that this energy can stimulate angiogenesis. The idea of applying Li-ESWT to the penis came from animal studies in which Li-ESWT was applied to the myocardium of pigs, where it has been reported that there was an improvement in ischemia-induced myocardial dysfunction (Nishida et al., 2004). Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora (Gruenwald et al., 2013). Oral phosphodiesterase-5 inhibitors (PDE-5 inhibitors), such as sildenafil and tadalafil, are usually the first-line treatment of erectile dysfunction. They are effective in a wide range of etiologies including cardiovascular disease, diabetes, and hypogonadism (Muneer et al., 2014) Contraction of the ischiocavernosus participates in the process of enhancing erectile rigidity by compressing the roots of the corpora cavernosa and inducing short-term suprasystolic intracavernosal pressures ((Cohen et al., 2016). Further, bulbospongiosus contraction leads to temporary engorgement of the glans penis and corpus spongiosum and results in similar short-term increases in intra spongiosal pressures (Siegel et al., 2014).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexual Dysfunction, Shock Wave

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-intensity Shockwave Therapy
    Arm Type
    Experimental
    Arm Title
    Kegel Exercises
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Low-intensity Shockwave Therapy
    Intervention Description
    patients will receive 6 sessions, once per week - of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level (Shendy et al, 2021) plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Kegel Exercises
    Intervention Description
    The training program consists of active exercises. Each patient will be taught how to contract the pelvic-floor muscles. He will be asked to mimic holding in the flow of urine and to contract the target muscles as hard as possible. The exercises will be done in a supine position with the knees flexed because it is easier to feel the pelvic-floor muscles in this position. The patient will be asked to perform short (1 second) and long-lasting (6-10 seconds) contractions of the target muscles. Later, the exercises will be done with the patient sitting or standing. Patient will be asked to repeat the contractions daily. Each patient will be performed 40 short and 50 long-lasting contractions in a prone, sitting, or standing position. Patients will be asked to do 30 contractions in the morning, 30 contractions in the afternoon, and 30 contractions in the evening.
    Primary Outcome Measure Information:
    Title
    Penile color-coded Duplex scanning
    Description
    for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.
    Time Frame
    baseline
    Title
    International Index of Erectile Function (IIEF-EF) questionnaire
    Description
    At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)
    Time Frame
    baseline

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Erectile dysfunction due to Type 2 diabetes for at least six months . Age between 35-55 years. Exclusion Criteria: - 1. Venogenic ED 2. Poly neuropathy 3. Past radical prostatectomy or extensive pelvic surgery 4. Recovering from cancer in the past 5 years 5. Any unstable medical and psychiatric disorder. 6. Spinal cord injury and another neurological disease 7. Penile anatomical abnormalities. 8. Clinically significant chronic hematological disease. 9. Anti-androgens or radiotherapy treatment of pelvic region. 10. Patients with untreated hypogonadism. 11. Psychogenic ED (normal nocturnal penile tumescence parameters) 12. Cardiovascular conditions that prevent sexual activity (heart attack, stroke, or life-threatening arrhythmia within the previous 6 months. 13. Patient with penile prosthesis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27872005
    Citation
    Cohen D, Gonzalez J, Goldstein I. The Role of Pelvic Floor Muscles in Male Sexual Dysfunction and Pelvic Pain. Sex Med Rev. 2016 Jan;4(1):53-62. doi: 10.1016/j.sxmr.2015.10.001. Epub 2016 Jan 8.
    Results Reference
    background
    PubMed Identifier
    15527607
    Citation
    Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25.
    Results Reference
    background
    PubMed Identifier
    27784587
    Citation
    Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
    Results Reference
    background

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    Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients

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