1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [email provided].
   


6. For how long will this data be available start date provided 25-04-2028 and end date provided 30-08-2025?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Post Menopausal Females with Stress Urinary Incontinence , aged between 44-55 Years will be randomized by computer-based randomization into 3 groups and will be treated with Pelvic Floor Muscle Training PFMT  ( Group A: Transvaginal PFMT , Group B: Supervised PFMT, Group C: Unsupervised PFMT, Home Program)

The objectives of the present study will be:

1.     To find the effect of Transvaginal Pelvic Floor Muscle Training on  Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence

2.     To find the effect of Supervised Pelvic Floor Muscle Training on  Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence

3.     To find the effect of Unsupervised Pelvic Floor Muscle Training on  Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence

4.     To compare the Effect of Transvaginal PFMT, Supervised PFMT & Non-supervised PFMT on Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence

Materials & Methods

•        All patients will be screened, will be informed about the study

•        Patients’ initial evaluation will include medical, gynaecological and incontinence-specific history,

•        Trans vaginal assessment of the pelvic floor muscles according to the Oxford scale, PERFECT Scale will be done & Incontinence Quality of Life Questionnaire.

•        Study will be conducted in Department of Physiotherapy, ABVIMS & Dr. Ram Manohar Lohia Hospital, New Delhi

•        Study Design: Randomised Controlled Study

•        Sampling: Convenience Sampling; Randomisation will be done by Computerised Generated Process.

•        Informed consent from patients & Approval from hospital research ethics committee will be taken

Methodology 

 Peri / Post Menopausal Females, Age 44 – 55, N = 123, will be Assessed for Eligibility as Per Inclusion & Exclusion Criteria

Group A , INTERVENTION GROUP ; TRANSVAGINAL PFM (N=41)  , Group B interventional GROUP, SUPERVISED GROUP SESSIONS PFM (N=41),  GROUP C, UNSUPERVISED, HOME PROG PFM (N=41)

ASSESSEMENT WILL BE DONE WITH OXFORD & PERFECT SCALE, which are transvaginal digital palpation methods where with the help of distal pad of index finger Pelvic Floor Muscles are assessed to detect any changes in resting tone, identify areas of atrophy & differentiate between state of contraction & relaxation.  Following parameters will be recorded:

1.      POWER (P) = STRENGTHOF PFM (OXFORD SCALE)

2.      ENDURANCE (E) sec

3.      NO OF REPETETIONS ( R ) WITH ENDURANCE E

4.      NO OF FAST TWITCH CONTRACTIONS (F)

5.      QUALITY OF LIFE 

TREATMENT WILL BE GIVEN TO ALL 3 GROUPS AS PER THE PROTOCOL, 2 SESSIONS /WEEK FOR 3 CONSECUTIVE MONTHS–> 1^ST MONTH PFM IN SUPINE LYING, 2^ND MONTH PFM IN SITTING, 3^RD MONTH PFM IN LYING

 Patient would be instructed to practice (R) Repetitions of her strongest contractions with Power (P) lasting Endurance of (E) seconds (with 4 seconds rest between) at each exercise session, and fast (F) strong contractions at other times. X 3 sets ; Patient will aim to increase the number of repetitions of the long MVC over subsequent weeks up to 10 repetitions. X 3 sets

In view of weak PFM, assessing the number of Fast Contractions would be confusing; & should be done at a later date when endurance improved to 4 seconds. Treatment should progress in the first instance by aiming to hold the contractions for 3 (then4) seconds. Once this is achieved, strength should be addressed & patient encouraged to contract harder. Once a grade 3 is achieved, endurance is once again addressed and subject encouraged to increase the length of contraction.

After this, over the succeeding weeks, treatment will aim to increase the hold time to 10 seconds. In addition, the number of fast contractions should be progressively increased to the maximum number possible (many patients can do up to 50 fast contractions). The aim is to be able to perform 10 repetitions of a 10-second MVC at regular intervals during the day, and 10+ fast contractions at other times during the day. Equal numbers of sessions of slow and fast contractions are encouraged, up to six per day

 REASSESSMENT WILL BE DONE AFTER EACH 1 MONTH FOR 3 CONSECUTIVE MONTHS (IN ALL 3 GROUPS)

APPROPRIATE STATISTICAL ANALYSIS & COMPARISON OF RESULTS WILL BE DONE.