| CTRI Number |
CTRI/2025/11/097721 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Physiotherapuetic intervention for Postpartum Women |
|
Scientific Title of Study
|
Effect Of Pelvic Floor Rehabilitation On Muscle Activity,Incontience, Sexual Function And Quality Of Life Among Postpartum Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPTHI RNV |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Dr. M.G.R. Educational and Research Institute |
| Address |
Faculty of physiotherapy,Dr. M.G.R. Educational and research institute ,Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
7016204378 |
| Fax |
|
| Email |
deepthi.physio@drmgrdu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEENAKIRTHIKA S |
| Designation |
VICE PRINCIPAL/JOINT REGISTRAR |
| Affiliation |
FACULTY OF PHYSIOTHERAPY Dr.M.G.R. Educational and Research Institute |
| Address |
Faculty of physiotherapy,Dr. M.G.R. Educational and research institute,Velappanchavdi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09884224990 |
| Fax |
|
| Email |
veena.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrVEENAKIRTHIKA S |
| Designation |
VICE PRINCIPAL/JOINT REGISTRAR |
| Affiliation |
FACULTY OF PHYSIOTHERAPY Dr.M.G.R. Educational and Research Institute |
| Address |
Faculty of physiotherapy,Dr. M.G.R. Educational and research institute,Velappanchavdi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09884224990 |
| Fax |
|
| Email |
veena.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
DEEPTHI RNV |
| Address |
Faculty Of Physiotherapy,Dr. M.G.R. Educational and Research Institute ,Velappanchavadi, Chennai |
| 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 |
| DrDEEPTHI RNV |
Physiotherapy Outpatient Department, A.C.S. Medical College And Hospital |
Faculty of Physiotherapy,Dr.M.G.R.Educational and Research institute, Chennai 600077
Chennai
TAMIL NADU |
7016204378
deepthi.physio@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITEE,Dr.M.G.R .Educational and Research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional training |
Conventional training - 4 session per week for 15 mins for 12 weeks |
| Intervention |
Pelvic Floor Muscle Stimulator |
Pelvic Floor Muscle Stimulator - 4 session per week for 15 mins for 12 weeks |
| Intervention |
Sit on Top Pelvic Floor Stimulator |
Sit on Top Pelvic Floor Stimulator -4 session per week for 15 mins for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primiparous Women: Women who have delivered their first child, either through vaginal delivery.
2.Normal vaginal delivery with episiotomy .
Postpartum Period: Participants should be within 6 weeks to 6 months postpartum, with PFM strength about moderate contraction(17.6-32.0 mmHg) using periniometer readings .
3.Pelvic Floor Dysfunction Symptoms: Women experiencing symptoms of pelvic floor dysfunction, such as urinary incontinence and sexual dysfunction.
4.Age Group: Women aged between 21 and 35 years |
|
| ExclusionCriteria |
| Details |
1.Cesarean section as a mode of delivery
2.Pre-existing Pelvic Floor Disorders: Women with diagnosed pelvic floor dysfunction prior to pregnancy (e.g., chronic incontinence or pelvic organ prolapsed).
3.Complicated Pregnancy or Delivery women who experienced severe obstetric complications, such as third- or fourth-degree perineal tears, severe postpartum hemorrhage, or emergency surgeries.
4.Medical Conditions Affecting Pelvic Floor Rehabilitation: Presence of conditions such as neurological disorders (e.g., multiple sclerosis, spinal cord injuries) or musculoskeletal disorders that impair pelvic floor function or exercise capability |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women.
for 8 weeks
the assessment will be done after 8 weeks . |
To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women.
for 8 weeks
the assessment will be done after 8 weeks . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the anxiety & depression associated with pelvis floor dysfunction.
posttest values will be assessed after 8 weeks .
Measure improvements in body image
Investigate changes in core muscle activity for 8 weeks |
To explore the anxiety & depression associated with pelvis floor dysfunction.
posttest values will be assessed after 8 weeks .
Measure improvements in body image
Investigate changes in core muscle activity for 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="3"
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
|
This experimental study follows a comparative pre- and post-test design, focusing on primiparous women who had normal vaginal deliveries. The study will be conducted at the outpatient physiotherapy department of ACS Medical College and Hospital, Dr. M.G.R. Educational & Research Institute. A total of 80 participants will be included in the study, selected through block randomization using the lottery method. The participants will fall within the age group of 21 to 35 years, and the study duration will span 12 months. Each intervention will be administered for 40 minutes per day, four days a week, with adequate intervals between sessions.The participants will be divided into three groups. Group A will receive pelvic floor muscle rehabilitation using a newly designed vaginal rectal stimulator combined with Kegel’s exercises. The vaginal rectal stimulation sensor, an intracavity probe, will be used to stimulate the pelvic floor muscles with mild electric currents targeting the nerves. This therapy is known to address issues such as urinary incontinence, anal dysfunction, and sexual dysfunction. Group B participants will undergo stimulation using a sit-on-top pelvic floor stimulator, which is a non-intracavity method, along with Kegel’s exercises. Finally, Group C will receive interferential therapy in combination with Kegel’s exercises. |