| CTRI Number |
CTRI/2024/12/077558 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Development And Evaluation Of Non – Invasive Biofeedback Device For The Pelvic Floor Muscle Training |
|
Scientific Title of Study
|
Development And Evaluation Of Non – Invasive Biofeedback Device For The Pelvic Floor Muscle Training: An Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hitiksha Rasik Dedania |
| Designation |
Assistant Professor , PhD Scholar |
| Affiliation |
Parul University, (PhD - Marwadi University) |
| Address |
Room No: 312,Physiotherapy department, Parul Institute of Physiotherapy, Parul University, Limbda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
6351047107 |
| Fax |
|
| Email |
hitiksha.dedania122039@marwadiuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Khant |
| Designation |
Associate Professor |
| Affiliation |
Marwadi University |
| Address |
5th Floor MB 512, Physiotherapy Department, College of Physiotherapy, Marwadi University
Rajkot-Morbi Road, Rajkot Gujarat, India
Rajkot
GUJARAT
360003
India |
| Phone |
7405117897 |
| Fax |
|
| Email |
ankurkumar.khant@marwadiuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Hitiksha Rasik Dedania |
| Designation |
Assistant Professor , PhD Scholar |
| Affiliation |
Parul University, (PhD - Marwadi University) |
| Address |
Room No: 312,Physiotherapy department, Parul Institute of Physiotherapy, Parul University, Limbda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
6351047107 |
| Fax |
|
| Email |
hitiksha.dedania122039@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Marwadi University
Marwadi University
Rajkot-Morbi Road, Rajkot 360 003 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Hitiksha Dedania |
| Address |
Marwadi University
Rajkot-Morbi Road, Rajkot 360 003 Gujarat, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Hitiksha Dedania |
Parul Institute of Phyysiotherapy |
Room No: 312,Physiotherapy department, Parul Institute of Physiotherapy, Parul University, Limbda, Vadodara
Vadodara
GUJARAT |
6351047107
hitiksha.dedania122039@marwadiuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Doctoral Research Committee, Marwadi University, Rajkot, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biofeedback |
Pelvic floor Biofeedback
Pelvic floor Muscle Strenght
Quality of Life |
| Intervention |
Pelvic Floor Training |
Pelvic Floor Exercise
Pelvic floor Biofeedback
8 weeks of Protocol
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Stress urinary incontinence symptoms
Moderate symptom distress by the urogenital distress inventory (UDI 6).
Mild or moderately severe urinary incontinence as indicated by the (ICIQ-UI SF)
|
|
| ExclusionCriteria |
| Details |
previous therapy or surgery for urinary incontinence
urge incontinence,
neurogenic urinary incontinence
uncontrolled diabetes
neurological abnormalities
urinary tract infection
previous therapy or surgery for urinary incontinence
urge incontinence,
neurogenic urinary incontinence
uncontrolled diabetes
neurological abnormalities
urinary tract infection
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| External observation method |
0 day 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pelvic floor impact questionnaire (PFIQ – 7) |
0 day 30th day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hitiksha.dedania122039@marwadiuniversity.ac.in].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The pelvic floor muscles play a critical role in maintaining urinary continence, supporting pelvic viscera, and facilitating sexual function. Dysfunction or weakness in these muscles can lead to a wide range of health issues, including urinary incontinence, pelvic organ prolapse, and sexual dysfunction. One promising approach to enhance the performance of the pelvic floor muscles is through the use of biofeedback devices. The electromyography (EMG) biofeedback device applied in clinical practice is not preferred by women with urinary incontinence because it is invasive, and involves the insertion of a probe into the vagina, causing pain. This research proposal aims at development of a non-invasive device that can provide feedback regarding the strength of pelvic floor muscles (PFM) contraction of the superficial layer of pelvic floor muscles. |