| CTRI Number |
CTRI/2020/07/026729 [Registered on: 22/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| 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
|
Muscle Training for improving Quality of Life of Women with Urine problem |
|
Scientific Title of Study
|
Effectiveness of Pelvic Floor Muscle Training on Quality of Life of Women with Urinary Incontinence: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARVIN AKTER |
| Designation |
Clinical Physiotherapist |
| Affiliation |
CRP |
| Address |
Musculoskeletal Unit, Department of physiotherapy
CRP, Savar, Dhaka, 1343
1343
Other |
| Phone |
01681722303 |
| Fax |
|
| Email |
parvin22303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parvin Akter |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Masters in Physiotherapy Student |
| Address |
Department of physiotherapy
CRP, Savar, Dhaka, 1343
1343
Other |
| Phone |
01681722303 |
| Fax |
|
| Email |
parvin22303@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Anwar Hossain |
| Designation |
Senior Consultant & Associate Professor |
| Affiliation |
CRP |
| Address |
Department of physiotherapy
CRP, Savar, Dhaka, 1343
1343
Other |
| Phone |
01753559949 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP) |
|
|
Primary Sponsor
|
| Name |
Parvin Akter |
| Address |
CRP, Savar |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammad Anwar Hossain |
Musculoskeletal Unit |
Department of physiotherapy
CRP, Savar, Dhaka, 1343
|
01753559949
anwar_physiobd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie Method & Pelvic Floor Strengthening |
McKenzie method
Soft tissue mobilization
Pelvic floor muscle training (Sustained contraction, quick contraction, Pelvic floor contraction with coughing).
Treatment session- 2 sessions per week, up to 6 weeks. |
| Comparator Agent |
McKenzie Protocol |
McKenzie method
Soft tissue mobilization
Abdominal muscle training
Treatment session- 2 sessions per week, upto 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients with LBP with urinary incontinence.
Age range: 40 to 60 years.
LBP ≥ 3 months.
|
|
| ExclusionCriteria |
| Details |
Patients with any neurological involvement.
Patients with hearing impairments.
Patients who received treatment for pelvic organ dysfunction.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Episodes of Incontinence |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="0"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/08/2020 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Urinary incontinence (UI) is an
important public health & social problem predominantly in women (Milsom et
al., 2013). According to the International Incontinence Society (ICS), UI is
defined as an involuntary loss of urine which affects in all ages especially in
fifth decade of life (Chang et al., 2017).The prevalence of this problem is of
25-45% all over the world. Daily incontinence affects between 5% and 15% of
middle aged and older women. Prevalence estimates of urinary incontinence
during pregnancy & postpartum period are even higher, as it is reported in
42% of pregnant women & 38 % of women post-partum (Morkved & Bo, 2014).
There are three main types of UI:
Stress urinary incontinence (SUI), urge urinary incontinence (UUI) and mixed
urinary incontinence (MUI). Among these the most common is Stress Urinary
incontinence (SUI) and its prevalence varies at 10-39%, mixed urinary incidence
(MUI) has a prevalence of 7.5-25% (Botlero, Davis, Urquhart, Shortreed, &
Bell, 2009). Thus, SUI and MUI constitute nearly two-thirds of the women with
urinary incontinence. |