| CTRI Number |
CTRI/2024/06/068798 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is PFMT effective for patients with overactive bladder post radical prostatectomy. |
|
Scientific Title of Study
|
"The Effect Of Pelvic Floor Muscle Training On Overactive Bladder Among Individuals with Post Radical Prostatectomy : 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 Onkar Bhagwat Raut |
| Designation |
Undergraduate |
| Affiliation |
MGM Institute of Physiotherapy , N-6,Cidco ,Aurangabad |
| Address |
Department of Neuro Physiotherapy OPD No-03,
MGM Institute of Physiotherapy,
N-6 Cidco, Aurangabad, Maharashtra ,India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9579734143 |
| Fax |
|
| Email |
onkar.b.raut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kale |
| Designation |
Professor and HOD |
| Affiliation |
MGM Institute of Physiotherapy , N-6,Cidco ,Aurangabad |
| Address |
Department of Neuro Physiotherapy OPD No-03,
MGM Institute of Physiotherapy,
N-6, Cidco , Aurangabad,Maharashtra ,India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7263891882 |
| Fax |
|
| Email |
ashwinikalept@yahooco.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Onkar Bhagwat Raut |
| Designation |
Undergraduate |
| Affiliation |
MGM Institute of Physiotherapy , N-6,Cidco ,Aurangabad |
| Address |
Department of Neuro Physiotherapy OPD No-03,
MGM Institute of Physiotherapy,
N-6, Cidco , Aurangabad,Maharashtra ,India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9579734143 |
| Fax |
|
| Email |
onkar.b.raut@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM INSTITUTE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
Department of neuro physiotherapy , MGM Institute of Physiotherapy , N-6,Cidco ,Aurangabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Onkar Bhagwat Raut |
MGM Medical College and Hospital |
Urology Surgery Ward, 5th floor, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
9579734143
onkar.b.raut@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: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Behavioral Therapy |
Behavioral Therapy is given along with standard care to this group which includes , General exercise , Counselling , Education , Dietary modification , self care, medication |
| Intervention |
Pelvic Floor Muscle Training |
Pelvic Floor exercises will be taught to the individuals and will be continued for 6 weeks along with standard care. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Individuals having bladder dysfunction post radical prostatectomy were included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals having communication difficulties 2. Individuals having cardiovascular complications ( unstable angina, uncontrolled hypertension ) 3.Individuals having bladder dysfunction prior to radical prostatectomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| overactive bladder symptom score |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2024 |
| 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="1"
Months="0"
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
|
AIMS & OBJECTIVES: AIMS OF STUDY 1. To evaluate effect of PFMT on overactive bladder among individual Radical Prostatectomy. OBJECTIVES 1. To evaluate overactive bladder among individual with post radical prostatectomy. 2. To study effect of PFMT on overactive bladder among individual post radical prostatectomy. METHODOLOGY STUDY DESIGN: Pilot Randomized Controlled Trial. SAMPLE METHOD: Convenient Method SAMPLE SIZE: 20 ( 10 in each group) STUDY DURATION: 6 weeks STUDY SETTING: Tertiary Care Hospitals all over the city of Aurangabad. INCLUSION CRITERIA: 1. Individuals having overactive bladder post Radical Prostatectomy as identified on the OABSS were included in the study EXCLUSION CRITERIA 1. Individuals having communication difficulties. 2. Individuals having other Cardio-vascular complications ( unstable angina, uncontrolled hypertension) 3. Individuals having overactive bladder prior to Radical Prostatectomy. MATERIALS USED 1. Informed consent form-A written, informed and signed consent form. 2. Data collection sheet 3. OABSS PROCEDURE 1. Study will be initiated after the approval of Institutional Ethical Committee. 2. After the approval, therapist gains training from a certified pelvic floor rehabilitation specialist for 6 weeks along with behavioral therapy . 3. Individuals who will be willing to participate in the study will be screened to meet the inclusive and exclusive criteria 4. Consent will be taken in written form before commencement of the protocol . 5. Each individual selected for the study will be explained about the purpose of the study 6. Subject will be assessed for overactive bladder after post radical prostatectomy 7. The subject will be divided into two group 8. Group A (experimental group) will be given Pelvic Floor Muscle Training with Behavioral therapy 9. Group B(controlled group) will be given Behavioural therapy. 10. The result will be analyse after the 6 weeks of treatment period.
|