| CTRI Number |
CTRI/2025/12/099384 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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
|
Effect of KNACK Maneuver in Women with Stress Urinary Incontinence. |
|
Scientific Title of Study
|
Effect of KNACK Maneuver on strength and coordination of Pelvic Floor Muscles and Quality of Life in women with Stress Urinary Incontinence : A 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 Lakshika Singhi |
| Designation |
Post Graduate student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Community Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9819965911 |
| Fax |
|
| Email |
lakshikssinghi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Parle |
| Designation |
HOD & Professor Department of Community Physiotherapy |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Community Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9321280391 |
| Fax |
|
| Email |
jyolvm2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Parle |
| Designation |
HOD & Professor Department of Community Physiotherapy |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third floor Department of Community Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9321280391 |
| Fax |
|
| Email |
jyolvm2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of Community Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai 410210 India |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Third floor, Department of Community Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar Kharghar Navi Mumbai |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Third floor, Department of Community Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar Kharghar Navi Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshika Singhi |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Third floor, Department of Community Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
9819965911
lakshikssinghi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee (Academics) |
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 |
| Comparator Agent |
Conventional Exercises |
Conventional (Kegels) exercises, 20-30mins/ sessions, 6 sessions/day for 4 weeks. |
| Intervention |
KNACK Maneuver |
KNACK Maneuver exercises, 20-30 minutes/ session, 6 sessions/ week for 4 weeks, progression from supine to functional activities in 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18 to 40 years.
2. Women with mild, moderate and severe stress urinary incontinence.
3. Primigravida and Multiparous female.
4. FTND and C-section females post 20 weeks of childbirth.
5. BMI: 18-30kg/m2
6. Women willing to participate and give written consent. |
|
| ExclusionCriteria |
| Details |
1. Perimenopausal and postmenopausal women.
2. Women with grade 2 & 3 pelvic floor organs prolapse or other pelvic floor disorders.
3. Pregnant women.
4. Nulliparous women.
5. Women with urge & mixed urinary incontinence.
5. Women diagnosed with fibroids.
6. Women who have undergone recent pelvic surgery.
7. Women diagnosed with any neurological, musculoskeletal and cardiorespiratory condition. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Oxford Scale by Laycock, Perineometer, Pelvic Floor Muscle Coordination Scale (PFMCS), International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms (ICIQ-LUTSQOL), Incontinence Severity Index (ISI). |
4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/01/2026 |
| 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="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
|
This Randomized Controlled Trial aims to evaluate the effect of the KNACK Maneuver on Pelvic Floor Muscle Strength and Coordination and Quality of Life in women aged 18 to 40 years with Stress Urinary Incontinence Thirty participants will be randomly allocated into a control group receiving Conventional Kegel’s exercises pelvic Floor Muscle training and an Intervention Group receing Kegels combined with KNACK Maneuver for 20 to 30 mins/session for 6sessions/week for 4 weeks Outcomes will be assessed using Objective and Subjective measures including Perineometer readings Modified Oxford Scale by Laycock Pelvic floor muscle coordination scale PFMCS Quality of life questionnaire and Incontinence Severity Index The study seeks to determine whether incorporating the KNACK Maneuver which emphasizes timely pelvic floor muscle activation during activities that increase the Intra abdominal pressure provides additional benefits over conventional training in improving continence control and overall quality of life |