| CTRI Number |
CTRI/2024/01/061708 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment Of Pelvic Floor Muscle Strength in Women and Its Associated Factors. |
|
Scientific Title of Study
|
Assessment Of Pelvic Floor Muscle Strength in Women and Its Associated Factors - A Cross Sectional Study in a Tertiary Care Centre. |
| 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 Sahana M B |
| Designation |
MS Obstetrics and Gynecology |
| Affiliation |
KAHERS Jawaharlal Nehru Medical College And Research Centre , Belagavi - 590010 |
| Address |
Department of Obstetrics and Gynecology
KAHERS Jawaharlal Nehru Medical College and Research Centre
Belgaum
KARNATAKA
590010
India |
| Phone |
9481776598 |
| Fax |
|
| Email |
sahanamalagi1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema Patil |
| Designation |
Associate Professor |
| Affiliation |
KAHERS Jawaharlal Nehru Medical College and Research Centre |
| Address |
Department of Obstetrics and Gynaecology
KAHERS Jawaharlal Nehru Medical College and Research Centre
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9164342888 |
| Fax |
|
| Email |
hemabanad@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sahana M B |
| Designation |
MS Department of Obstetrics and Gynaecology |
| Affiliation |
KAHERS Jawaharlal Nehru Medical College And Research Centre |
| Address |
KAHERS Jawaharlal Nehru Medical College and Research Centre
Belgaum
KARNATAKA
590010
India |
| Phone |
9481776598 |
| Fax |
|
| Email |
sahanamalagi1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS Jawaharlal Medical College and Research Centre, Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHERS Jawaharlal Nehru Medical College and Research Centre |
| Address |
KAHERS Jawaharlal Nehru Medical College and Research Centre
Belagavi- 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sahana M B |
KAHERS Jawaharlal Nehru Medical College and Research Centre, Belagavi |
KAHERS Jawaharlal Nehru Medical College and Research Centre, Belagavi 590010
Belgaum
KARNATAKA |
9481776598
sahanamalagi1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Perineometer |
Pelvic Floor Muscle Strength will be assessed using Perineometer . The insert will be covered with latex sleeve for each patient and will be inserted into the vaginal canal, women are asked to squeeze with maximum perceived effort as long as possible. The baseline pressure reading will be recorded. Maximum peak of each contraction is noted and average of three readings will be taken to avoid biased results. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Nulliparous (>18yrs up to attainment of menopause)
2. Premenopausal multiparous (6months after delivery up to attainment of menopause)
3. Postmenopausal women visiting Gynecology and Urogynecology OPD at KLEs
Prabhakar Kore Charitable Hospital and Medical Research Centre, Belagavi. |
|
| ExclusionCriteria |
| Details |
• Pregnancy
Women in postpartum period (upto 6months after delivery)
• Cognitive / Physical disability
• Women who are not consenting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess Pelvic Floor Muscle Strength in Women & Its Associated Factors By Using Vaginal Digital Palpation & Perineometer |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life affecting in a Woman with Pelvic Floor Muscle Weakness. |
One year |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
30/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2024 |
| 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 - NO
|
|
Brief Summary
|
1.The incidence of pelvic floor muscles weakness in women is around 12 to 60% . Though Pelvic floor weakness is very common, many women don’t disclose about their problems and hence early detection is delayed and the benefits from interventions like physical, sexual and professional life are not obtained. PFMS can be associated with factors like age, parity, mode of delivery, prolonged labor and menopausal status. 2.Very few studies have examined the effect of age on pelvic floor muscle strength with the aim to standardize reference value of pelvic floor muscle strength in women and difference in nulliparous, premenopausal parous and postmenopausal women. This study aims to give further insight into this topic. |