FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079037 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Investigating Role of Homoeopathy in treating Urinary incontinence after menopause 
Scientific Title of Study   Role Of Homoeopathy In Urinary Incontinence In Post Menopausal Age 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samiha Suleman Khatri 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice Of Medicine Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  7575084787  
Fax    
Email  samiha91786@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer S Upadhyay 
Designation  HOD of Practice Of Medicine 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice Of Medicine Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Samiha Suleman Khatri 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice Of Medicine Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  7575084787  
Fax    
Email  samiha91786@yahoo.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeopathic Medicine and Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India 
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samiha Suleman Khatri  C D Pachchigar College of Homoeopathic Medicine and Hospital  Department Of Practice Of Medicine Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT 
7575084787

samiha91786@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C D Pachchigar College of Homoeopathic Medicine and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N399||Disorder of urinary system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoeopathic medicine Dose as per requirement of case through Sublingual Mode of Administration within time duration of 9 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women in post-menopausal period.
Women of all socio-economic strata.
Patient with regular follow up.
 
 
ExclusionCriteria 
Details  Women of age below 45 years.
Women who have undergone total hystero-salpingo- oophorectomy.
Patient with urinary incontinence which requires surgical intervention.
Patient with any irreversible pathology.
Patient who left treatment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Role of Homoeopathy in managing Urinary Incontinence in Post Menopausal Age   9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Role of Homoeopathy in Managing Urinary Incontinence In Post Menopausal Age with Healthy lifestyle   9 Months 
 
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 2 
Date of First Enrollment (India)   28/01/2025 
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="0"
Months="9"
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  


6. BRIEF REVIEW OF INTENDED WORK:

6.1

NEED FOR STUDY:

          Menopause is a critical period in the life of every woman. The time of menopausal transition is often marked by metabolic changes that affect the health of a woman. It causes many unpleasant symptoms that worsen the quality of life of many women. These symptoms are very often the result of hormonal and metabolic changes. In post-menopausal age low oestrogen levels is major culprit causing various genito-urinary problems. It has been established that the lower urinary tract is sensitive to the effects of oestrogen.

          Urinary incontinence (UI) is involuntary leakage of urine which is an important social problem that affects more than 50% of postmenopausal women. The number of patients increases from year to year, affected by the rapid social development contributing to a sedentary lifestyle and the lack of time for any physical activity particularly evident in the elderly. These factors weaken the overall performance of the body, leading to weakness of the muscles or bones, respiratory disorders and circulatory problems. One common problem that affects postmenopausal women is incontinence of urine. (1)

          The problem of involuntary leakage of urine significantly affects the quality of life of affected women. It negatively affects many aspects of life, significantly reducing the daily functioning associated with work, physical activity or the intimate sphere. Urinary incontinence is the main symptom of genitourinary syndrome in post-menopause (GSM) and is often associated with sexual dysfunctions.

          Urinary incontinence (UI) is an important social problem that affects more than 50% of postmenopausal women. The number of patients increases from year to year. According to recent data, UI affects women twice as often as men. This condition occurs in about 20-30% of young women, 30-40% in middle age and up to 50% of women in old age which covers post-menopausal period. (1) Prevalence is found increased in female during adulthood to 30%, stabilizing between the age of 50 and 70 yrs old. (2)Approximately 50% of women suffer from stress Urinary Incontinence, 11% of women from Urgency Urinary Incontinence and 36% from Mixed Urinary Incontinence. (2)

          Homoeopathy being an effective system of medicine deals with any diseased condition in holistic way and offers great help in management of the diseases by working on principle of ‘Law of Similar – Similia Similibus Curanture’. Homoeopathy works by individualizing whereby considering one person different from the other and treating accordingly. The holistic science works by considering the person as a whole and not merely considering the disease to be treated.

 

6.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6.3

 

 

 

 

 

 

REVIEW OF LITERATURE:

Definition:

        Urinary Incontinence is defined as objectively demonstrable involuntary loss of urine so as to cause hygienic and/ or social inconvenience for day-to-day activity. (3)

 

Classification: (3)

It is divided into,

Urethral

Extra-urethral

1)    Urethral sphincter incompetence/ Genuine Stress Incontinence (GSI).

2)    Detrusor Overactivity (DO).

3)    Mixed Urinary Incontinence (GSI & DO).

4)    Overflow Incontinence (acute and chronic)

5)    Functional & others

6)    Congenital

1)    Acquired:

                Fistula - Vesical

                              Urethral

                              Ureteral

2)    Congenital:

Ectopic ureter & others.

 

 

(1) Genuine Stress Incontinence/ Anatomic Incontinence/ Urethral Sphincter Incompetence:

 

Definition: (3)

       GSI is defined according to International Continence Society as involuntary urethral loss of urine when intravesical pressure exceeds the maximum urethral pressure in absence of detrusor overactivity.

Urine leaks when abdominal pressure rises e.g., when coughing or laughing.

 

Pathophysiology:

Anatomic incontinence is primarily the result of,

1) Hypermobility of vesico-urethral segment owing to pelvic floor weakness. In this descent of bladder neck and proximal urethra which normally lies above urogenital diaphragm which hinders rise of intravesical pressure during straining. (3)

2) Lowered urethral pressure. (3)

3) Intrinsic sphincter deficiency – in which malfunction of sphincter regardless of its anatomical position. (2)

 

 

 

Factors responsible for these are, (3)

·       Developmental weakness of supporting structures.

·       Childbirth trauma causing damage of pelvic floor and puborectal fascia.

·       Pregnancy due to increase levels of progesterone.

·       Post-menopausal age – in which estrogen insufficiency causing atrophy of supporting structures.

·       Trauma.

·       Following surgery.

·       Increasing age.

·       Obesity.

 

Sign and symptoms: (3)

Escape of urine with coughing, laughing, sneezing.

Lost urine is,

     1) In small amount.

     2) Unassociated with a desire to pass urine.

     3) Patient is fully aware of it.

     4) Rarely in supine position/ during sleep.

     5) Brief & coincides precisely to the period of raised Intra-abdominal Pressure.

 

Investigation: (3) (4)

1)    Stress test.

2)    Pad test.

3)    Frequency volume chart.

4)    Urodynamic study.

5)    Uroflowmetry.

6)    Cytometry.

7)    MRI.

 

Diagnosis: (3) (4)

According to this investigation and on clinical basis,

1)    Grade 1: UI during coughing/ sneezing, jogging.

2)    Grade 2: UI on mild exercise like fast walking, going up and down stairs.

3)    Grade 3: UI even in recumbent position, standing.

   

Treatment: (3) (4)

1)    Pelvic floor muscle exercise.

2)    Lifestyle modification.

3)    High frequency electrical stimulation.

4)    Drugs – oestrogen therapy, alpha – adrenergic drugs.

5)    Surgery – To restore the normal anatomy and to strengthen the support of bladder neck and proximal urethra.

 

(2) Urge Incontinence:

 

A. Motor Urge Incontinence/ Unstable Bladder/ Detrusor Instability:

 

Definition: An unstable bladder is defined by International Continence Society as “one that is shown objectively to contract spontaneously or on provocation during filling phase while the patient attempting to inhibit micturition. (3) (4)

 

Etiology: (3) (4)

A.    Functional and psycho somatic.

B.    Detrusor hyper-reflexia (Neuropathic) i.e., hypertonic detrusor stimulation.

C.    Following surgery.

D.    Idiopathic.

E.    Urinary tract infection. (4)

 

Pathophysiology: (4)

There is increased alpha-adrenergic and cholinergic activity.

 

Symptoms: (3) (4)

·       Involuntary loss of urine without prior urge to urinate.

·       Frequency is >7times/day or at least 1time/night.

·       Bedwetting during sleep.

 

Investigation: (4)

1.     Neurological examination.

2.     Blood sugar levels.

3.     Urine routine and culture.

4.     Cystometry.

5.     USG.

 

Treatment: (3)

·       Behavioral therapy.

·       Bladder training.

·       Drugs.

·       Surgery which includes denervation or cystoplasty.

 

B. Sensory Urge Incontinence/ Stable Bladder:

Definition: Involuntary leakage of urine per urethra accompanied by or immediately preceded by urgency. It is unassociated with detrusor contraction until urination is initiated. No anatomical descent of urethra and bladder. (3)

(2) Mixed Urinary Incontinence (GSI + UI): (3)

In this type of urinary incontinence symptoms of both GSI and UI are

present. Its treatment is initiated towards predominant symptoms.

 

(3) Overflow Incontinence: (3)

This occurs because of prolonged and neglected retention. Mechanism is overdistension of bladder which pulls and open internal sphincter of urinary bladder. Hence urine escapes involuntarily.

 

(4) Post-micturition dribble: (2)

      Involuntary loss of urine immediately after the individual has finished passing urine, usually after leaving the toilet in men and after rising from toilet in women.

A recent standardization by the International Uro-gynecology Association and the International Continence Society on female pelvic floor dysfunction recommends new definition including,

·       Continuous Incontinence: The complaint of continuous involuntary loss of urine.

·       Insensible Incontinence: The complaint of UI where the women has been unaware of how it occurred.

·       Coital Incontinence: Complain of involuntary loss of urine with coitus.

 

 

Ø  ASSESSMENT OF URINARY INCONTINENCE: (2)

Assessment of the disease will be done according to International Consultation on Incontinence Modular Questionnaire.

 

MENOPAUSE AND POST-MENOPAUSE:

 

Menopause: Is permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. (3)

Age of Menopause: Ranges between 45-55 yrs average being 50 yrs of 50 years. (3)

Post-Menopausal Period: Is the phase of life that comes after the menopause. (3)

 

Post-menopausal Symptoms  (5)

    Postmenopausal symptoms are primarily attributed to the decreased level of circulating estrogen. Hot flashes, vulvovaginal atrophy, and sexual dysfunction result from the complex changes that occur around menopause.

 

Hot Flushes:

    The aetiology of hot flashes is complex. There is thought to be resetting and narrowing of the thermoregulatory system secondary to the fluctuations or loss of oestrogen production. Hot flashes have also been thought to be due to alteration in both oestrogen and FSH levels.

Vulvo-vaginal Atrophy:

    Urogenital tissues are highly sensitive to oestrogen, and lack of oestrogen causes atrophy and shortening of the vagina, uterine prolapse, and dyspareunia. Decreased oestrogen levels affect the urinary tract, including the bladder and urethra, and many develop urinary incontinence.

 

Sexual Dysfunction:

    Unlike hot flashes and vulvovaginal atrophy, the aetiology of sexual dysfunction does not correlate with hormonal changes. The decreased libido could also be attributed to the vasomotor symptoms, sleep disturbance, and mood changes in postmenopausal women.

 

Pathophysiology: (5)

    There is progressively dwindling of ovarian follicles as a woman ages. The ovarian oestrogen and inhibin production decreases because of the loss of granulosa cells. The FSH and LH level remains high because of the lack of negative feedback from the ovary. Androgen production from the ovary continues beyond the menopausal transition because of the sparing of the stromal compartment. Menopausal women continue to have low levels of circulating oestrogens, principally from peripheral aromatization of ovarian and adrenal androgens.

 

HOMOEOPATHIC MANAGEMENT OF URINARY INCONTINENCE

 

INDIVIDUALIZATION:

     Individualization is cardinal principle of homoeopathy. It is a process of differentiating an object or a person from a group of similar objects or persons.

     Homoeopathy recognizes the individuality of each drug and substance in nature. Its method of testing or ‘proving’ drugs upon the healthy human beings is designed and used for the purpose of bringing out the individuality of each drug so that full power and relations are established.

Ø  In aphorism 118 of Organon of Medicine, Dr. Hahnemann writes:

“Every medicine exhibits peculiar action on the human frame, which are not produced in exactly the same manner by other medicinal substance of a different kind.” (6)

     Homoeopathy recognizes the individuality of each patient. It recognizes the fact that no two cases or patients, even with the same diseases, are exactly alike. Homoeopathy treats the patient as a whole and not a disease. In the other word individualizes.

 

 

 

 

 

HOMOEOPATHIC MEDICINES:

 

There are few Homoeopathic medicines which can be used in cases of urinary incontinence:

 

Causticum: (7)

Involuntary urination when coughing, sneezing. Expelled very slowly, and sometimes retained. Involuntary during first sleep at night, also from slightest excitement. Loss of sensibility on passing urine.

 

Sepia: (8)

Involuntary urination during first sleep; worse coughing, sneezing, laughing; hearing sudden noise, fright or inattention especially in women. Slow urination, with bearing down sensation above pubis. Shuddering when urging for urine is not attended to.

 

Kreosotum: (7)

Enuresis in first part of night. Must hurry when desire comes to micturate. Urine offensive

 

Apis: (7)

Burning and soreness while micturating. Suppressed, loaded with casts; frequent and involuntary; sting and strangury, scanty, high colored. Incontinence. Last few drops burns and smart.

 

Pulsatilla: (7)

Increased desire; worse when lying down. Burning in urethral orifice during and after micturition. Involuntary at night, while coughing or passing flatus. After micturating, spasmodic pain in the bladder.

 

Some other medicines which can be given according to similarity of similarity are,

·       Sulphur, Natrum mur, Thuja, Dulcamara, Arsenicum Album, Phosphorus.

 

 

 

OBJECTIVE OF STUDY:

1)    To study urinary incontinence in post-menopausal age women.

2)    To determine the role of homoeopathy in urinary incontinence in post-menopausal age women.

 

 

 

 

7.

MATERIALS AND METHODS:

7.1

SOURCES OF DATA:

Project site:

1)    O.P.D and I.P.D of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital, Surat.395 001.

2)    O.P.D of fixed peripheral centers arranged by Chandrvatiben Dhansukhlal Pachchigar college Of Homoeopathic Medicine and Hospital.

7.2

MATERIALS:

Materials that will be utilized in study are,

·       Standard case taking formate of O.P.D. of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine And Hospital.

·       Books:

1)    Various clinical and gynecological books related to my study.

2)    All Homoeopathic literature related to my study.

·       Homoeopathic Computerized software – Synthesis repertory by Dr.Fredrerik Schroyens, MD.

·       Websites and articles related to my study.

·       For Assessment: International Consultation on Incontinence Modular Questionnaire will be used.

 

7.3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

METHODS OF COLLECTION OF DATA:

·       Study Design: Experimental study.

·       Study Type: Prospective study.

·       Study Population: Cases having complain of Urinary Incontinence to be treated with Homoeopathic Medicine at Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine & Hospital.

·       Method of sampling: Simple random sampling.

·       Sample size: 30 cases.

 

·       Criteria of selection of cases:

a)    INCLUSION CRITERIA:

o   Women in post-menopausal period.

o   Women of all socio-economic strata.

o   Patient with regular follow up.

 

b)    EXCLUSION CRITERIA:

o   Women of age below 45 years.

o   Women who have undergone total hystero-salpingo-oophorectomy.

o   Patient with urinary incontinence which requires surgical intervention.

o   Patient with any irreversible pathology.

o   Patient who left treatment.

 

Ø  Case taking will be done according to guidelines mentioned in Aphorisms 83-104 by Dr. Hahnemann in Organon of Medicine.

Ø  After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

Ø  Medicine will be selected either from Repertorial or Non-Repertorial approach.

Ø  The remedy will be used in various potencies as per requirement of case.

Ø  The remedies will be administered as per guidelines given by Dr. Hahnemann in Organon of Medicine.

Ø  Route of administration is through oral route.

Ø  The remedies will be repeated as per the requirement of the case.

Ø  Follow up of each case will be taken as per requirement of case.

Ø  Homoeopathic remedies will be dispensed from C.D.Pachchigar College Of Medicine and Hospital Pharmacy.

 

 

Ø  Response will be analyzed into 3 criteria,

1)    Improvement:

General sense of well-being with reduction in intensity and frequency of presenting symptoms.

2)    Not improved:

A complain will continue to progress.

7.4

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENT OR OTHER HUMANS OR ANIMAL?

 

 

As per the requirement of case.

7.5

HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION?

 

Yes.

 

 

6. BRIEF REVIEW OF INTENDED WORK:

6.1

NEED FOR STUDY:

          Menopause is a critical period in the life of every woman. The time of menopausal transition is often marked by metabolic changes that affect the health of a woman. It causes many unpleasant symptoms that worsen the quality of life of many women. These symptoms are very often the result of hormonal and metabolic changes. In post-menopausal age low oestrogen levels is major culprit causing various genito-urinary problems. It has been established that the lower urinary tract is sensitive to the effects of oestrogen.

          Urinary incontinence (UI) is involuntary leakage of urine which is an important social problem that affects more than 50% of postmenopausal women. The number of patients increases from year to year, affected by the rapid social development contributing to a sedentary lifestyle and the lack of time for any physical activity particularly evident in the elderly. These factors weaken the overall performance of the body, leading to weakness of the muscles or bones, respiratory disorders and circulatory problems. One common problem that affects postmenopausal women is incontinence of urine. (1)

          The problem of involuntary leakage of urine significantly affects the quality of life of affected women. It negatively affects many aspects of life, significantly reducing the daily functioning associated with work, physical activity or the intimate sphere. Urinary incontinence is the main symptom of genitourinary syndrome in post-menopause (GSM) and is often associated with sexual dysfunctions.

          Urinary incontinence (UI) is an important social problem that affects more than 50% of postmenopausal women. The number of patients increases from year to year. According to recent data, UI affects women twice as often as men. This condition occurs in about 20-30% of young women, 30-40% in middle age and up to 50% of women in old age which covers post-menopausal period. (1) Prevalence is found increased in female during adulthood to 30%, stabilizing between the age of 50 and 70 yrs old. (2)Approximately 50% of women suffer from stress Urinary Incontinence, 11% of women from Urgency Urinary Incontinence and 36% from Mixed Urinary Incontinence. (2)

          Homoeopathy being an effective system of medicine deals with any diseased condition in holistic way and offers great help in management of the diseases by working on principle of ‘Law of Similar – Similia Similibus Curanture’. Homoeopathy works by individualizing whereby considering one person different from the other and treating accordingly. The holistic science works by considering the person as a whole and not merely considering the disease to be treated.

 

6.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6.3

 

 

 

 

 

 

REVIEW OF LITERATURE:

Definition:

        Urinary Incontinence is defined as objectively demonstrable involuntary loss of urine so as to cause hygienic and/ or social inconvenience for day-to-day activity. (3)

 

Classification: (3)

It is divided into,

Urethral

Extra-urethral

7)    Urethral sphincter incompetence/ Genuine Stress Incontinence (GSI).

8)    Detrusor Overactivity (DO).

9)    Mixed Urinary Incontinence (GSI & DO).

10) Overflow Incontinence (acute and chronic)

11) Functional & others

12) Congenital

3)    Acquired:

                Fistula - Vesical

                              Urethral

                              Ureteral

4)    Congenital:

Ectopic ureter & others.

 

 

(1) Genuine Stress Incontinence/ Anatomic Incontinence/ Urethral Sphincter Incompetence:

 

Definition: (3)

       GSI is defined according to International Continence Society as involuntary urethral loss of urine when intravesical pressure exceeds the maximum urethral pressure in absence of detrusor overactivity.

Urine leaks when abdominal pressure rises e.g., when coughing or laughing.

 

Pathophysiology:

Anatomic incontinence is primarily the result of,

1) Hypermobility of vesico-urethral segment owing to pelvic floor weakness. In this descent of bladder neck and proximal urethra which normally lies above urogenital diaphragm which hinders rise of intravesical pressure during straining. (3)

2) Lowered urethral pressure. (3)

3) Intrinsic sphincter deficiency – in which malfunction of sphincter regardless of its anatomical position. (2)

 

 

 

Factors responsible for these are, (3)

·       Developmental weakness of supporting structures.

·       Childbirth trauma causing damage of pelvic floor and puborectal fascia.

·       Pregnancy due to increase levels of progesterone.

·       Post-menopausal age – in which estrogen insufficiency causing atrophy of supporting structures.

·       Trauma.

·       Following surgery.

·       Increasing age.

·       Obesity.

 

Sign and symptoms: (3)

Escape of urine with coughing, laughing, sneezing.

Lost urine is,

     1) In small amount.

     2) Unassociated with a desire to pass urine.

     3) Patient is fully aware of it.

     4) Rarely in supine position/ during sleep.

     5) Brief & coincides precisely to the period of raised Intra-abdominal Pressure.

 

Investigation: (3) (4)

8)    Stress test.

9)    Pad test.

10) Frequency volume chart.

11) Urodynamic study.

12) Uroflowmetry.

13) Cytometry.

14) MRI.

 

Diagnosis: (3) (4)

According to this investigation and on clinical basis,

4)    Grade 1: UI during coughing/ sneezing, jogging.

5)    Grade 2: UI on mild exercise like fast walking, going up and down stairs.

6)    Grade 3: UI even in recumbent position, standing.

   

Treatment: (3) (4)

6)    Pelvic floor muscle exercise.

7)    Lifestyle modification.

8)    High frequency electrical stimulation.

9)    Drugs – oestrogen therapy, alpha – adrenergic drugs.

10) Surgery – To restore the normal anatomy and to strengthen the support of bladder neck and proximal urethra.

 

(2) Urge Incontinence:

 

A. Motor Urge Incontinence/ Unstable Bladder/ Detrusor Instability:

 

Definition: An unstable bladder is defined by International Continence Society as “one that is shown objectively to contract spontaneously or on provocation during filling phase while the patient attempting to inhibit micturition. (3) (4)

 

Etiology: (3) (4)

F.    Functional and psycho somatic.

G.   Detrusor hyper-reflexia (Neuropathic) i.e., hypertonic detrusor stimulation.

H.    Following surgery.

I.      Idiopathic.

J.     Urinary tract infection. (4)

 

Pathophysiology: (4)

There is increased alpha-adrenergic and cholinergic activity.

 

Symptoms: (3) (4)

·       Involuntary loss of urine without prior urge to urinate.

·       Frequency is >7times/day or at least 1time/night.

·       Bedwetting during sleep.

 

Investigation: (4)

6.     Neurological examination.

7.     Blood sugar levels.

8.     Urine routine and culture.

9.     Cystometry.

10. USG.

 

Treatment: (3)

·       Behavioral therapy.

·       Bladder training.

·       Drugs.

·       Surgery which includes denervation or cystoplasty.

 

B. Sensory Urge Incontinence/ Stable Bladder:

Definition: Involuntary leakage of urine per urethra accompanied by or immediately preceded by urgency. It is unassociated with detrusor contraction until urination is initiated. No anatomical descent of urethra and bladder. (3)

(2) Mixed Urinary Incontinence (GSI + UI): (3)

In this type of urinary incontinence symptoms of both GSI and UI are

present. Its treatment is initiated towards predominant symptoms.

 

(3) Overflow Incontinence: (3)

This occurs because of prolonged and neglected retention. Mechanism is overdistension of bladder which pulls and open internal sphincter of urinary bladder. Hence urine escapes involuntarily.

 

(4) Post-micturition dribble: (2)

      Involuntary loss of urine immediately after the individual has finished passing urine, usually after leaving the toilet in men and after rising from toilet in women.

A recent standardization by the International Uro-gynecology Association and the International Continence Society on female pelvic floor dysfunction recommends new definition including,

·       Continuous Incontinence: The complaint of continuous involuntary loss of urine.

·       Insensible Incontinence: The complaint of UI where the women has been unaware of how it occurred.

·       Coital Incontinence: Complain of involuntary loss of urine with coitus.

 

 

Ø  ASSESSMENT OF URINARY INCONTINENCE: (2)

Assessment of the disease will be done according to International Consultation on Incontinence Modular Questionnaire.

 

MENOPAUSE AND POST-MENOPAUSE:

 

Menopause: Is permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. (3)

Age of Menopause: Ranges between 45-55 yrs average being 50 yrs of 50 years. (3)

Post-Menopausal Period: Is the phase of life that comes after the menopause. (3)

 

Post-menopausal Symptoms  (5)

    Postmenopausal symptoms are primarily attributed to the decreased level of circulating estrogen. Hot flashes, vulvovaginal atrophy, and sexual dysfunction result from the complex changes that occur around menopause.

 

Hot Flushes:

    The aetiology of hot flashes is complex. There is thought to be resetting and narrowing of the thermoregulatory system secondary to the fluctuations or loss of oestrogen production. Hot flashes have also been thought to be due to alteration in both oestrogen and FSH levels.

Vulvo-vaginal Atrophy:

    Urogenital tissues are highly sensitive to oestrogen, and lack of oestrogen causes atrophy and shortening of the vagina, uterine prolapse, and dyspareunia. Decreased oestrogen levels affect the urinary tract, including the bladder and urethra, and many develop urinary incontinence.

 

Sexual Dysfunction:

    Unlike hot flashes and vulvovaginal atrophy, the aetiology of sexual dysfunction does not correlate with hormonal changes. The decreased libido could also be attributed to the vasomotor symptoms, sleep disturbance, and mood changes in postmenopausal women.

 

Pathophysiology: (5)

    There is progressively dwindling of ovarian follicles as a woman ages. The ovarian oestrogen and inhibin production decreases because of the loss of granulosa cells. The FSH and LH level remains high because of the lack of negative feedback from the ovary. Androgen production from the ovary continues beyond the menopausal transition because of the sparing of the stromal compartment. Menopausal women continue to have low levels of circulating oestrogens, principally from peripheral aromatization of ovarian and adrenal androgens.

 

HOMOEOPATHIC MANAGEMENT OF URINARY INCONTINENCE

 

INDIVIDUALIZATION:

     Individualization is cardinal principle of homoeopathy. It is a process of differentiating an object or a person from a group of similar objects or persons.

     Homoeopathy recognizes the individuality of each drug and substance in nature. Its method of testing or ‘proving’ drugs upon the healthy human beings is designed and used for the purpose of bringing out the individuality of each drug so that full power and relations are established.

Ø  In aphorism 118 of Organon of Medicine, Dr. Hahnemann writes:

“Every medicine exhibits peculiar action on the human frame, which are not produced in exactly the same manner by other medicinal substance of a different kind.” (6)

     Homoeopathy recognizes the individuality of each patient. It recognizes the fact that no two cases or patients, even with the same diseases, are exactly alike. Homoeopathy treats the patient as a whole and not a disease. In the other word individualizes.

 

 

 

 

 

HOMOEOPATHIC MEDICINES:

 

There are few Homoeopathic medicines which can be used in cases of urinary incontinence:

 

Causticum: (7)

Involuntary urination when coughing, sneezing. Expelled very slowly, and sometimes retained. Involuntary during first sleep at night, also from slightest excitement. Loss of sensibility on passing urine.

 

Sepia: (8)

Involuntary urination during first sleep; worse coughing, sneezing, laughing; hearing sudden noise, fright or inattention especially in women. Slow urination, with bearing down sensation above pubis. Shuddering when urging for urine is not attended to.

 

Kreosotum: (7)

Enuresis in first part of night. Must hurry when desire comes to micturate. Urine offensive

 

Apis: (7)

Burning and soreness while micturating. Suppressed, loaded with casts; frequent and involuntary; sting and strangury, scanty, high colored. Incontinence. Last few drops burns and smart.

 

Pulsatilla: (7)

Increased desire; worse when lying down. Burning in urethral orifice during and after micturition. Involuntary at night, while coughing or passing flatus. After micturating, spasmodic pain in the bladder.

 

Some other medicines which can be given according to similarity of similarity are,

·       Sulphur, Natrum mur, Thuja, Dulcamara, Arsenicum Album, Phosphorus.

 

 

 

OBJECTIVE OF STUDY:

3)    To study urinary incontinence in post-menopausal age women.

4)    To determine the role of homoeopathy in urinary incontinence in post-menopausal age women.

 

 

 

 

7.

MATERIALS AND METHODS:

7.1

SOURCES OF DATA:

Project site:

3)    O.P.D and I.P.D of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital, Surat.395 001.

4)    O.P.D of fixed peripheral centers arranged by Chandrvatiben Dhansukhlal Pachchigar college Of Homoeopathic Medicine and Hospital.

7.2

MATERIALS:

Materials that will be utilized in study are,

·       Standard case taking formate of O.P.D. of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine And Hospital.

·       Books:

3)    Various clinical and gynecological books related to my study.

4)    All Homoeopathic literature related to my study.

·       Homoeopathic Computerized software – Synthesis repertory by Dr.Fredrerik Schroyens, MD.

·       Websites and articles related to my study.

·       For Assessment: International Consultation on Incontinence Modular Questionnaire will be used.

 

7.3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

METHODS OF COLLECTION OF DATA:

·       Study Design: Experimental study.

·       Study Type: Prospective study.

·       Study Population: Cases having complain of Urinary Incontinence to be treated with Homoeopathic Medicine at Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine & Hospital.

·       Method of sampling: Simple random sampling.

·       Sample size: 30 cases.

 

·       Criteria of selection of cases:

c)     INCLUSION CRITERIA:

o   Women in post-menopausal period.

o   Women of all socio-economic strata.

o   Patient with regular follow up.

 

d)    EXCLUSION CRITERIA:

o   Women of age below 45 years.

o   Women who have undergone total hystero-salpingo-oophorectomy.

o   Patient with urinary incontinence which requires surgical intervention.

o   Patient with any irreversible pathology.

o   Patient who left treatment.

 

Ø  Case taking will be done according to guidelines mentioned in Aphorisms 83-104 by Dr. Hahnemann in Organon of Medicine.

Ø  After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

Ø  Medicine will be selected either from Repertorial or Non-Repertorial approach.

Ø  The remedy will be used in various potencies as per requirement of case.

Ø  The remedies will be administered as per guidelines given by Dr. Hahnemann in Organon of Medicine.

Ø  Route of administration is through oral route.

Ø  The remedies will be repeated as per the requirement of the case.

Ø  Follow up of each case will be taken as per requirement of case.

Ø  Homoeopathic remedies will be dispensed from C.D.Pachchigar College Of Medicine and Hospital Pharmacy.

 

 

Ø  Response will be analyzed into 3 criteria,

3)    Improvement:

General sense of well-being with reduction in intensity and frequency of presenting symptoms.

4)    Not improved:

A complain will continue to progress.

7.4

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENT OR OTHER HUMANS OR ANIMAL?

 

 

As per the requirement of case.

7.5

HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION?

 

Yes.

 

8.

BIBILOGRAPHY:

1.

Gabriela Kołodyńska MZaKRP. National Institue of Health. [Online].; 2019 [cited 2024 Jan 29. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528037/.

2.

John Reynard SBSB. Oxford Handbook of Urology. 3rd ed. Great Clarendon Street, United Kingdom: Oxford University Press; 2013.

3.

D.C.Dutta. D.C.Dutta’s Textbook of Gynecology including Contraception. 7th ed. Konar H, editor. New Delhi: Jaypee; 2016.

4.

Bourne H&. Shaw’s Textbook of Gynaecology. 16th ed. VG Padubiri SND, editor.: Reed Reed Elsevier India Private Limited; 2015.

5.

Rupa Koothirezhi SR. National Institue of Health. [Online].; 2023 [cited 2024 Jan 29. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560840/.

6.

Hahnemann S. Organon Of Medicine. 6th ed. New Delhi: Indian Books & Periodicals Publishers; Jan 2013.

7.

Boericke W. Boerickes’s New Manual of Homoeopathic Materia Medica with Repertory. 3rd ed. New Delhi: B.Jain Publishers; 1 April 2010.

8.

S.R.Phatak. Materia Medica of Homeopathic Medicine. Reprint ed. New Delhi: Indian Books & Periodicals Publishers; Oct, 2011.

 

 

 

 

        

 

                                            

 
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