| CTRI Number |
CTRI/2024/01/061962 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In our study we include a patient who is suffering from erectile dysfunction of penis. we will be giving pelvic floor exercises and stimulation to see its effect on erection. |
|
Scientific Title of Study
|
Effectiveness of electrical stimulation with and without pelvic floor
muscle training in improving quality of life and erectile dysfunction among
sedentary middle-aged population – A Pilot Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuj Unhale |
| Designation |
MPT resident |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of
Physiotherapy, N-6,Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9834668076 |
| Fax |
|
| Email |
anujunhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor, Department of Musculoskeletal Physiotherapy |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of
Physiotherapy, N-6,Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Unhale |
| Designation |
MPT resident |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of
Physiotherapy, N-6,Cidco, Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9834668076 |
| Fax |
|
| Email |
anujunhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuj Unhale |
MGM Physiotherapy and Rehabilitation Centre |
Department of musculoskeletal physiotherpy ,C Building, MGM
Physiotherapy and
Rehabilitation Centre,
N-6,Cidco, Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
09834668076
anujunhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
pelvic floor muscle training is given for strengthening in five different position with 3 maximal contraction at each time |
| Intervention |
electrical stimulation |
we apply functional electrical stimulation for soft tissue regeneration with (50Hz/500microsec) for 3 times a week for 15 minutes for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Men age 30-65 year
2. Men who suffering from ED more than 6 months or more.
3. ED due Veno-occlusive and due arterial insufficiency
referred by Andrologist |
|
| ExclusionCriteria |
| Details |
1.Uro-congenital conditions.
2. Neurological deficit
3. Previous urological surgery like prostatectomy.
4. Cardiac pathologies |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| International Index Of erectile function-5 |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Erectile dysfunction – effect on quality of life |
baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recruitment of the participants will be started after the 1st Jan 2024. Total 30 participants will be recruited in the study. This divided into 2 groups - Interventional and Control group. Interventional group has 15 participants and control has 15 participants. We will be giving a electrical stimulation to Interventional group and pelvic floor training to the control group. This study duration for 4 weeks after that reassessment will be taken. Primary outcome was IIEF-5 scale and ED-QOL scale for erectile function and quality of life. Unpaired t test will be calculated and p value is of <0.05 is significant.
|