| CTRI Number |
CTRI/2023/07/054699 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Combined Effect of Neuromuscular Electrical Stimulation and Pelvic Floor Exercises in Multiparous Females with Urinary Incontinence |
|
Scientific Title of Study
|
Effect of Neuromuscular Electrical Stimulation & Pelvic Floor Strengthening Exercises in Multiparous females with Stress Incontinence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti Tanwar |
| Designation |
Masters Student |
| Affiliation |
Guru Jambheshwar University of Science & Technology |
| Address |
Department Of Physiotherapy,
Guru Jambheshwar University of Science & Technology, Neurophysiotherapy, Hisar
Hisar
HARYANA
125001
India |
| Phone |
7015090690 |
| Fax |
|
| Email |
bhartitanwar212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science & Technology |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Neurophysiotherapy, Room no. 101, Hisar
Hisar
HARYANA
125001
India |
| Phone |
8708711667 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science & Technology |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
8708711667 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy Guru Jambheshwar University of Science Technology Hisar Haryana |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Hisar |
| Type of Sponsor |
Other [] |
|
|
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 |
| Bharti Tanwar |
OPD, Health Centre, Guru Jambheshwar University of Science & Technology, Hisar |
Department of Physiotherapy, Neurophysiotherapy, Room no. 4,5 Guru Jambheshwar University of Science & Technology, Hisar
Hisar
HARYANA |
7015090690
bhartitanwar212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of neuromuscular electrical stimulation and pelvic floor strengthening exercises |
This group received the combination of neuromuscular electrical stimulation and pelvic floor strengthening exercises |
| Comparator Agent |
Control group |
This group received pelvic floor strengthening exercises which includes Kegel’s exercise, Bridging, Squats, Single leg raise, clamshell, Contraction of the thigh adductors by pressing a ball and then relax. Each participant received 10 repetitions of each exercise with 10 seconds hold. Treatment was given for 4 times/week for 8 weeks. |
| Intervention |
Neuromuscular electrical stimulation group |
A portable NMES (Intelect®NMES) with 2 sets of electrode pads was used. One pair of electrode was placed at the second sacral level, on both sides of the spinal column. On the other hand, the second pair of electrode was positioned at the insertion of
levator ani. Each patient was treated with 50 Hz frequency, 250ðœ‡s pulse duration with
constant mode for 15 minutes/day for 4 days/week for 8 weeks. The current intensity was gradually increased until it reached the tolerable limits for each patient.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Stress incontinence diagnosed by gynaecologist
Patients having symptoms of Stress incontinence patients who do not benefit from any other conservative treatment |
|
| ExclusionCriteria |
| Details |
Malignant condition
Neurological disease
Infection
Pregnancy
Cardiac implants and pacemakers
Urinary retention
Sensory loss
Anxiety disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
International Consultation on Incontinence questionnaire-urinary incontinence short form
King’s Health Questionnaire |
At baseline, 8 weeks and 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/07/2023 |
| 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 Applicable |
| 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
|
Among women, stress urinary incontinence is the most common form. Stress urine incontinence defines as involuntary leakage from the urethra that occurs synchronously with exertion/effort, sneezing, or coughing. Women face stress incontinence which is often go unsupported due to lack of awareness and societal shame. Neuromuscular electrical stimulation is applied in an effort to re-establish urinary continence mechanisms by strengthening the pelvic floor muscles, which are used when stimulation of the pudendal nerve results in a direct contraction of the pelvic floor muscles. Exercises for the pelvic floor muscles are used to treat stress urine incontinence because these muscles maintain the pelvic organs and aid in the urethral sphincter’s closure mechanism. This study includes the combined treatment of neuromuscular electrical stimulation and pelvic floor strengthening exercises. |