Rajiv Gandhi University of Health Sciences s39

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / REJISHA T.R
HARIPRIYA, MUNDAYAD (P.O)
KANNUR, KERALA.
2. / NAME OF THE INSTITUTION / THE OXFORD COLLEGE OF PHYSIOTHERAPY, NO.6/9,1STCROSS, BEGUR ROAD,
HONGASANDRA, BANGALORE: 560068
3. / COURSE OF THE STUDY AND SUBJECT / MASTER OF PHYSIOTHERAPY (MPT)
CARDIO-RESPIRATORY DISORDERS AND INTENSIVE CARE.
4. / DATE OF THE ADMISSION TO THE COURSE / 28-5-2010
5. / TITLE OF THE STUDY
“EFFECT OF ANTENATAL PELVIC FLOOR MUSCLE EXERCISES ON POSTNATAL INCIDENCE OF STRESS URINARY INCONTINENCE
IN PRIMIGRAVIDA- AN EXPERIMENTAL STUDY”.
6.
7.
8. / BRIEF RESUME OF THE INTENDED WORK :
6.1. NEED OF THE STUDY :
Women health and physiotherapy in gynecology have been a matter of concern since 1950's, but due to social and cultural limitations the problems of womanhood have been under reported.
Postpartum Stress Urinary Incontinence is one such socially and emotionally challenging problem faced by women with major economical and psychological effects on society.1
The ICS defines urinary incontinence (UI) as the involuntary loss of urine, which is objectively demonstrable, with such severity that it is a social or hygienic problem.2
Stress Incontinence, also known as effort incontinence, is due to insufficient strength of the pelvic floor muscle. It can be defined as the involuntary loss of urine during an increase in intra-abdominal pressure produced from activities such as coughing, sneezing, laughing or exercise2. The risk factors of SUI are found to be inherited weak connective tissue, vaginal delivery, obesity strenuous work or old age.3.
Prevalence of stress incontinence in pregnancy is 20-67% and in postpartum it is 29-
31% 4Its incidence is estimated to be 40-82 %.5
Most often Stress incontinence is a transient condition attributed to the enlarged uterus, fluctuating hormone levels, increases glomerular filtration rates, temporary changes in the urethrovesical angle, or other normal changes of pregnancy. Incontinence usually resolves in the first three months of delivery but in some women, the problem persists after delivery. Postpartum incontinence is typically attributed to the pathophysiological changes that occur as a result of delivery, such as bladder trauma or weakness of the pelvic floor muscles. 5,6,7,8,9
The pelvic floor muscles can be strengthened by the Kegels Exercises, named after Dr.Arnold Kegel, consists of contraction and relaxation of these muscles. The aim of Kegels Exercise is to improve the muscle tone by strengthening the pubococcygeus muscle of the pelvic floor. It is a properly prescribed exercise for pregnant women to prepare the pelvic floor for physiological stresses of the later stage of the pregnancy and vaginal delivery.10
But the effect of antenatal pelvic floor muscle exercise or antenatal Kegels exercise in postnatal incidence of Stress urinary incontinence have to be studied in detail.
I strongly believe that if antenatal pelvic floor muscle training is found to be effective in decreasing postnatal Stress urinary incontinence, then one of the most challenging problems of womanhood is being addressed to, thus giving her a better opportunity to serve the community.
6.2. REVIEW OF LITERATURE :
1) Kari.B (1999)11 stated in a study comparing the effect of pelvic floor muscle training vs electrical stimulation and vaginal cones in treatment of genuine stress incontinence that pelvic floor muscle exercise is superior to electrical stimulation and vaginal cones in the treatment of stress incontinence.
2) Th. Dimpfl (1992) 5 in his study Incidence and cause of postpartum urinary stress incontinence estimated the incidence of postpartum urinary stress incontinence to be between 40-82%.
3) L. Mouritsen (2008)12 carried out a study to assess the permanent effect of pelvis floor muscle exercises on female stress incontinence and concluded that PFMT have a long standing effect and can be an alternative to surgical procedures as 47% of subjects avoided the surgeries.
4) I.Hahn (2008)13 stated that continued guidance from a physiotherapist could improve the long-term efficacy of PFE training.
5) Markved S (2003) 14stated that intensive pelvic floor muscle training during pregnancy urinary incontinence during pregnancy and after delivery. Pelvic floor muscle strength improved significantly after intensive pelvic floor muscle training. The results also showed that a specially designed postpartum pelvic floor muscle exercise course is effective in increasing pelvic floor muscle strength and reducing urinary incontinence in the immediate postpartum.
6) Hay Smith J (2009)15 suggested that there is evidence that PFMT in women having their first baby can prevent urinary incontinence in late pregnancy and postpartum. It is possible that the effects of PFMT might be greater with targeted rather than population-based approaches and in certain groups of women.
7) Berghmans LCM (2003)16analysed that pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. Side effects of pelvic floor muscle training were uncommon and reversible.
8) K.Bo (1994)17 found that Leakage index is reliable and valid in measuring stress urinary incontinence in patients.
9) Dumoulin C (2006)18support for the widespread recommendation for PFMT to be included in the first line conservative management for women with stress ,mixed or urge incontinence
6.3. OBJECTIVES OF THE STUDY:
·  To analyze the efficacy of antenatal pelvic floor muscle training in postnatal incidence of SUI in primigravidas. .
·  To find the level of involvement of postnatal SUI in primigravidas with or without Pelvis floor muscle training undergoing a normal vaginal delivery.
6.4. HYPOTHESES :
a). Research hypothesis :
·  Antenatal pelvic floor muscle exercise may have its effect on the incidence of postnatal SUI in primigravidas
b). Null hypothesis :
·  Antenatal pelvic floor muscle exercise may not have any effect on the incidence of postnatal SUI in primigravidas.
MATERIALS AND METHODS :
7.1. STUDY DESIGN AND SETTING:
7.1.1. STUDY DESIGN :
·  Experimental study
7.1.2. SOURCE OF DATA :
·  Gynecology and Physiotherapy centers in and around Bangalore.
7.2. METHODOLOGY :
7.2.1. POPULATION :
·  Primigravidas in their 6th month, aged 24-30.
7.2.2. SELECTION CRITERIA :
1. INCLUSION CRITERIA :
·  Primigravidas
·  Age 24-30
·  6th month of pregnancy20
·  Single foetus
2. EXCLUSION CRITERIA :
·  Multigravidas
·  High risk pregnancies
·  Known case of SUI.
7.2.3. SAMPLING METHOD AND SAMPLE SIZE :
a) Sampling method: Convenient sampling.
b) Sample size: 70 subjects.
7.2.4. PROCEDURE :
Subjects, who satisfied the selection criteria, will be allocated at convenience to the experimental and control group.
Subjects will be given handouts explaining the antenatal period, the postnatal period, the effect of pregnancy on their pelvic floor muscles and its consequences, and the effect of PFM (Kegels) exercise on their pelvic floor muscle.
The experimental group (group A) will be given pelvic floor muscle from their 6th month of pregnancy as follows:
·  Correct muscle identification: Identify the pelvic floor muscles involved by purposely stopping the flow of urine in midstream and then allowing the urine to flow again ,These are the muscles that squeeze the urethra (levator ani and pubococcygeus)
·  Remembering what it felt like to control these muscles during urination, try to contract them without urinating. If your stomach muscles tighten, your pelvic muscles are not being exercised correctly.
·  For Slow contracting fibers of pelvic floor muscles: Slow Kegels exercise19
·  Contract your pelvic muscles for 10 seconds and then relax them for 10 seconds.
·  Breathe in during relaxation period and breathe out during contraction.
·  Repeat the Kegel exercises 8 to 12 times each session, and do at least 3 sessions a day.
·  For fast contracting fibers of pelvic floor muscles :Fast Kegels exercise.19
·  Rapid contraction of PFMs, 5-10 contraction at a stretch and repeated 3 times daily.
·  Monitoring: self monitoring can be done using a mirror- when performed correctly the PFME pulls the perineum inward. This method can be used as a biofeedback and help the subject to perform the exercise correctly.19
·  These exercises can be done in lying, sitting or in standing position in a progession19.
·  The subjects are seen twice a week for supervised exercise sessions, but will be instructed to do the exercise 3-4 times a week for 15 to 20 weeks( till term)20
The control group, group (B) are given standard information about the antenatal and postnatal changes and breathing exercise, but not the Kegels exercise from the 6th month of pregnancy. Those subjects among the experimental and the control group who underwent a normal vaginal delivery not a c-section or other assisted deliveries will be interviewed at the end of their 1st postnatal month in regard to the SUI experienced by them using leakage index 11 as the outcome measure.
MATERIALS REQUIRED :
·  Mat
·  Mirror
·  Chair
OUTCOME MEASURES :
·  Leakage index
7.3. STATISTICAL ANALYSIS :
The researcher will use paired t- test for data analysis
7.4 a) Does the study require any investigation to be conducted on patients or other humans or animals?
Yes, the study will be conducted among population in primigravida females from their 6th month of pregnancy. Prior permission from the college principal is taken for the study.
b) Has the ethical consent for the study has been obtained from the institution is case?
·  Yes, it has been obtained from the Institution.
·  Ethical clearance form is attached as appendix (I)
·  The informed consent will be obtained prior to study from each subject in their native language is attached as appendix (II)
REFERENCES :
1.  Jose Mary Sangeetha.X. A comparative study between comprehensive pelvic floor muscle training and conservative pelvic floor muscle training in prevention of stress urinary incontinence. The Indian Journal of Occupational Therapy 2010;XLII(1):78-83.
2.  (1)Abrams P. The standardization of terminology of lower urinary tract function. Scand Journal Urology and Nephrology 1988;114:5–19.
3.  Fantl.J. Urinary incontinence in adults: acute and chronic management. Scand Journal Urology Nephrology1996;117:681-682.
4.  Leanza V. Pregancy and stress urinary incontinence (SUI): a literature review. Obstetrics & Gynecology 2008;78:276-280.
5.  Th. Dimpfl. Incidence and cause of postpartum urinary stress incontinence. European Journal of Obstetrics & Gynecology and Reproductive Biology 1992;43:29-33.
6.  Meyer S, Schreyer A, Hohlfeld P. The effects of birth on urinary continence mechanisms and other pelvic –floor characteristics. Obstetrics Gynecology 1998;92:613-8.
7.  Chaliha C, Kalia V, Stanton SL et al. Antenatal prediction of postpartum urinary and fecal incontinence. Obstetrics & Gynecology 1999;94:689–94.
8.  Wilson PD, Herbison RM, Herbison GP. Obstetric practice and the prevalence of urinary incontinence three months after delivery. Britan Journal Obstetrics & Gynecology 1996; 103:154–61.
9. Farrell SA, Allen VM, Baskett TF. Parturition and urinary incontinence in primiparas.
Obstetrics & Gynecology 2001;97:350-356.
10.  Kegel exercise. Medline plus.www.medlineplus.com.
11. Keri.Bo. Effect of pelvic floor muscle training v/s electrical stimulation and vaginal cones in
treatment of genuine stress incontinence. BMJ 1999;318:487.
12. L. Mouritsen. Long-term Results of Pelvic Floor Training in Female Stress Urinary
Incontinence. British Journal of Urology 1991;68:32-37.
13. I.Hahn.Results of Pelvic Floor Training in Female Stress Urinary Incontinence.
British Journal of Urology 1993;72:421-427.
14. Markved S. Pelvic Floor Muscle Training During Pregnancy to Prevent Urinary Incontinence:
A Single-Blind Randomized Controlled Trial. Obstetrics & Gynecology 2003;101:313-319.

15. Hay Smith. Pelvic floor muscle training for prevention and treatment of urinary and faecal

Incontinence in antenatal and postnatal women. Evidence based medicine 2009;14(2):53.

16. Brahmans LCM. Pelvic floor muscle training for urinary incontinence in women. Obstetrics
& Gynecology 2003;97:172-176.
17. K. Bo. Reproducibility or instruments designed to measure subjective evaluation of female
Stress urinary incontinence. Scand J Urology and Nephrology. 1994;28:97-100.
18.  Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments for urinary incontinence. British Journal of Urology 2006;68:276-278.
19.  Judith Florendo. Kegels De-Mystified for Women British Journal of Obstetrics& Gynecology 2008; 26:3.
20. K.Bo. Pelvic floor muscle exercise for treatment of stress urinary incontinence: An exercise
physiology perspective. Journal International Urogynecology 2007;6(5):282-291
9. / Signature of the Candidate
10. / Remarks of the guide
11. / NAME AND DESIGNATION OF THE GUIDE
11.1 Guide / Mr. k. g. kirubakaran mpt
Principal
11.2 Signature
11.3 Head of the Department / Mr. C. DINESH
11.4 Signature
12. / 12.1 Remarks of chairman &
Principal
12.2 Signature

APPENDIX- I

THE OXFORD COLLEGE OF PHYSIOTHERAPY

NO.6/9&6/11,1ST CROSS, BEGUR ROAD, HONGASANDRA,

BANGALORE-560068.

Review Board on Ethics for Research

We hereby declare that the project titled, “EFFECT OF ANTENATAL PELVIC FLOOR MUSCLE TRAINING ON POSTNATAL INCIDENCE OF STRESS URINARY INCONTINENCE IN PRIMIGRAVIDA- AN EXPERIMENTAL STUDY ”, carried out by Mrs. REJISHA T.R of 1st Year M.P.T. has been brought forward for scrutiny to the board members. After analyzing the objectives, subjects involved and the methodology of the study, the following conclusions were drawn.

The study does not cause any mental or physical harm to the subjects involved and there are no risks involved in the study. The performance of the study procedure will not cause any injury to the subjects. The board has evaluated and confirmed that the experimenter is trained and qualified in measuring outcome. The informed consent form ensures that the experimenter explains the procedure of the study to the subjects, their voluntary participations is confirmed and the identification of subjects is maintained confidential.

More over the finding of the study will benefit similar subjects, the profession and the society.

Hence the review board has no objections on the conduct of the study.

Chairman of Departmental Review Board:

Project guide Principal

APPENDIX II

ETHICAL CONSENT FORM

I, the undersigned, have fully understood that

Mrs.………………………………………………………………………………………………………………… is being used as a subject for undertaking the scientific study titled “EFFECT OF ANTENATAL PELVIC FLOOR MUSCLE TRAINING ON POSTNATAL INCIDENCE OF STRESS URINARY INCONTINENCE IN PRIMIGRAVIDA- AN EXPERIMENTAL STUDY.”