Effectiveness of aletris farinosa in stress urinary incontinence in females of age group 40 to 60 years: a prospective case series study

INTRODUCTION

The term urinary incontinence is described as any involuntary leakage of urine. The types of urinary incontinence are stress incontinence, urge incontinence, continual incontinence, overflow incontinence.

Stress urinary incontinence

Stress urinary incontinence is termed as sudden, involuntary leakage of urine due to increased intraabdominal pressure. The activities that leads to leakage of urine are coughing, laughing, sneezing, straining or exercising. The risk factors for Stress urinary incontinence include age, obesity, pregnancy, multiple vaginal deliveries.

Grades of Stress Incontinence

Grade I  Incontinence on cough or sneeze

Grade II  With mild exercise

Grade III  with change of posture.

This study aims to investigate the effectiveness of Aletris Farinosa in managing stress urinary incontinence in females aged 40 to 60 years using a case series approach.

Aletris farinosa is indicated in uterine atony, prolapsus of uterus with endometritis, leucorrhoea tendency to abortion. It has been termed as the China of Uterine system.

Aletris Farinosa in Homoeopathic Practice Aletris Farinosa, commonly known as True Unicorn Root or Colic Root is a homoeopathic remedy made from the root of the Aletris plant. It has traditionally been used to treat various female reproductive and urinary system disorders, particularly those related to weakness and dysfunction of the pelvic organs. In homoeopathy, Aletris Farinosa is believed to strengthen the pelvic muscles and tissues, which may be beneficial in conditions like stress urinary incontinence. The remedy is also thought to promote the overall health of the bladder and urinary tract, making it a potentially effective treatment option for Stress Urinary Incontinence.

AIM AND OBJECTIVE

To evaluate the utility of Aletris farinosa in stress urinary incontinence in females of age group 40 to 60 years.

OTHER OBJECTIVES 1

To evaluate the utility of Aletris farinosa in any other associated complaint along with stress urinary incontinence.

1. STUDY DESIGN

A Prospective case series study.

2. STUDY SETTING

Cases are collected from

a. OPD and IPD of homoeopathic medical college.

b. Peripheral OPDs run by the homoeopathic medical college.

3. STUDY POPULATION

Females from various socio economic status.

Age between 40 to 60 years will be considered for study.

4. DURATION OF STUDY

18 months during the course after the approval of title.

Follow up

As per the requirement depending upon the severity of symptoms.

5 METHOD OF SELECTION OF STUDY SUBJECT

a. Inclusion criteria

1.Patients with involuntary leakage of urine since last 3 months.

2.Females of age group 40 to 60 years.

3.Patients who provide positive responses to question 1,2 and 3 of QUID scale.

4.Patients with signed written informed consent.

b. Exclusion criteria

1.Patients with history of surgery to correct incontinence.

2.Pregnant and Lactating females.

3.Immunocompromised patients.

4.Patients with addiction of alcohol and smoking.

5.Patients with modifiable factors such as heavy lifting.

6.Women with a history of pelvic organ prolapse Grade 2 or higher or severe pelvic floor disorders requiring surgical correction.

7.Women currently participating in another clinical trial for urinary incontinence.

c. Subject withdrawal criteria

1.Cases with irregular follow ups.

2.Patients who are on Parallel treatment for the same or other disease.

3.Patients who are not following protocol.

4.Disease progressing even after receiving treatment for 6 months, will be withdrawn.

6. OPERATIONAL DEFINITION

Stress is Increased intraabdominal pressure which increases the pressure on urinary bladder.

Incontinence is Inability of the body to control evacuative function of urination.

Prospective is future oriented

Aletris farinosa is a Homeopathic medicine.

7. SPECIFICATION OF INSTRUMENTS & RELATED MEASUREMENTS

Questionnaire for female urinary incontinence diagnosis

The system for scoring the severity of incontinence.

Improved Relief of signs and symptoms and general well being of the patient.

Not improved No relief of complaints after sufficient period of treatment.

Sample size 30 cases

Sampling technique Simple random sampling.

Data management and analysis procedure

After filling case record format symptoms of the case will be repertorised using Radar 10 software. Pre and post symptom severity score will be recorded and maintained using excel sheets. The analysis of the collected data will be done as per appropriate statistical test to assess effectiveness of homeopathic intervention.