Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006883953546 Date of Registration: 22/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF LOW INTENISITY EXTRA COPOREAL SHOCK WAVES THERAPY ON ERECTILE DYSFUNCTION IN PATIENTS WITH DIABETIC POLYNEUROPATHY
Official scientific title EFFECT OF LOW INTENISITY EXTRA COPOREAL SHOCK WAVES THERAPY ON ERECTILE DYSFUNCTION IN PATIENTS WITH DIABETIC POLYNEUROPATHY
Brief summary describing the background and objectives of the trial The purposes of this study will be: - To investigate the effectiveness of low intensity extracorporeal shock wave therapy on erectile function and penile rigidity in diabetic polyneuropathy patients with ED.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial low intensity extracorporeal shock wave therapy will affect erectile function in diabetic polyneuropathy patients
Anticipated trial start date 10/06/2018
Actual trial start date 10/07/2018
Anticipated date of last follow up 10/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group both low intensity extracorporeal shock wave therapy and pelvic floor muscle exercises. 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 - The protocol consists of 6 treatment sessions, once per week - Pelvic floor exercises. - The shock waves delivered through the applicator covering the corpora cavernosa of the penis along the penile shaft and the crura 6 treatment sessions, once per week - Receive 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 (Vardi et al., 2010). - The protocol consists of 6 treatment sessions, once per week - Pelvic floor exercises. - The shock waves delivered through the applicator covering the corpora cavernosa of the penis along the penile shaft and the crura 20
Control Group pelvic floor muscle exercises. 15 minute 6 weeks - Each patient was attend an individual physical therapy session in faculty of physical therapy at south valley university 1 times per week over a period of 1.5 months. - Because the physical therapist intervention might have an impact on the psychological and interpersonal relationship of the patient and his partner, the partner was asked to attend at least one treatment session. - During the first session, the physical therapist explained the anatomy of the pelvic floor, the erection process, and the function of the ischiocavernous and the bulbocavernous muscles during an erection. - The training program consists of active exercises. Each patient taught how to contract the pelvic-floor muscles. He asked to mimic holding in the flow of urine and to contract the target muscles as hard as possible. The exercises done in a supine position with the knees flexed because it is easier to feel the pelvic-floor muscles in this position. The therapist performed a digital intra-anal examination to verify if the muscle contraction was correct and selective. The therapist taught the patient how to contract the pelvic-floor muscles by squeezing the therapist’s finger. - The patient was asked to perform short (1 second) and long-lasting (6–10 seconds) contractions of the target muscles. Later, the exercises will do with the patient sitting or standing. - Patient asked to repeat the contractions daily. Each patient performed 40 short and 50 long-lasting contractions in a prone, 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Erectile dysfunction due to diabetic polyneuropathy for at least six months (Reisman et al., 2014). 2. Age between 35-60 years. 3. Body mass index not more than 32 4. Type 2 diabetes 5. Heterosexual men in stable heterosexual relationship for at least 3 months (Reisman et al., 2014). 6. IIEF-EF between 7 to 24 (mild to moderate ED) (Ruffo et al., 2015). 7. Responders and non-responders to phosphodiesterase type 5 inhibitors (PDE5-i) (Reisman et al., 2014). 1. Past radical prostatectomy or extensive pelvic surgery (Ruffo et al., 2015). 2. Recovering from cancer in the past 5 years (Reisman et al., 2014). 3. Any unstable medical, psychiatric disorder. 4. Spinal cord injury and another neurological disease (Amado et al., 2015). 5. Penile anatomical abnormalities (Ruffo et al., 2015). 6. Clinically significant chronic hematological disease (Reisman et al., 2014). 7. Anti-androgens or radiotherapy treatment of pelvic region (Ruffo et al., 2015). 8. Patients with untreated hypogonadism (Amado et al., 2015). 9. Psychogenic ED (normal NPT parameters) (Yoram et al., 2010). 10. Cardiovascular conditions that prevent sexual activity (heart attack, stroke or life-threatening arrhythmia within the previous 6 months (Vasan et al., 2015). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 60 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2018 cairo univerisity faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
eltahrir street cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement of erectile dysfunction in these patients 6 weeks
Secondary Outcome improve ability of erection 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
south valley univerisity south valley univerisity qena 83523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
abdelrazak abdelnaeim ahmed mahmoud 54 sharaf eldeen street banha Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor south valley university south valley univerisity quena 83523 Egypt University
COLLABORATORS
Name Street address City Postal code Country
assistant professor dr wael salah tawfik shendy 7 ahmed elzayat street dokii 12611 Egypt
dr omar mohamed elsoghier Qena-safaga road Qena 83523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator wael shendy dr_shendy@hot.mail 00201001006711 eltagamaa street
City Postal code Country Position/Affiliation
cairo Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries moataz elsemary wmohammed605@yahoo.com 00966554062074 saudia
City Postal code Country Position/Affiliation
cairo Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries omar alsoghier omarelsoqier1983@yahoo.com 00201095421734 qena
City Postal code Country Position/Affiliation
qena Egypt lecturer in urology departement
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographical data, and measurement data Study Protocol 1 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information