MedPath

Homeopathic medicines for involuntary urination in old aged people

Phase 2/3
Completed
Conditions
Unspecified urinary incontinence,
Registration Number
CTRI/2022/04/041931
Lead Sponsor
D N De Homoeopathic Medical College and Hospital
Brief Summary

Urinary incontinence (UI) is an inability to regulate the physical, physiological, or functional factors involved in the process of urination that leads to an involuntary loss of urine. According to the International Association of Urinary Incontinence, any involuntary leakage of urine is called UI. The highest prevalence of UI in older adult women was reported in Asia as 45.1%. Though homeopathy is one of the popular therapies in UI, research evidence is infrequent and inconclusive. A six-month, double-blind, randomized, placebo-controlled trial on 60 geriatric people with UI was conducted at D. N. De Homoeopathic Medical College and Hospital to identify the differences between individualized homeopathic medicines (IHMs; n = 30) and identical-looking placebos (n = 30) in the mutual context of concomitant care, e.g., lifestyle modifications including dietary habits, restriction in drinking, weight loss for obese persons, and pelvic floor muscle exercises. The primary outcome measure was the International Consultation on Incontinence Questionnaire – Urinary Incontinence – Short Form (ICIQ-UI-SF); the secondary outcome measure was the Quality-of-Life Scale (QOLS) – all measured at monthly intervals, up to 6 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences and effect sizes. Two groups were comparable at baseline. After 6 months of intervention, group differences were statistically significant in ICIQ-UI-SF (P = 0.002). The secondary outcome could not demonstrate any statistical significance, either in the total score (P = 0.086) or in other subscales, except recreation (P = 0.002). Twenty-nine different remedies were prescribed – Sulphur, Thuja occidentalis, and Causticum were the most frequently indicated ones. Thus, IHMs produced promising results in comparison with placebos in managing UI in geriatric people. Independent replication is required to confirm the findings.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

a) Patients suffering from urinary incontinence (ICD-10 code R32 in geriatric people) since last 3 months b) Leakage of urine with or without control c) Age 60 – 75 years d) Patients of either sex e) Literate patients; ability to read English and/or Bengali f) Providing written informed consent.

Exclusion Criteria
  • a) Patients having neurological conditions, such as known multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury. b) Patient who has been dealing with urinary symptoms with several modern medication in the past one month or any plan to have surgical treatment during the study. c) Participants will be excluded if they had uterine prolapsed grade 3 or 4, vesicovaginal fistula; and any severe cardio-vascular diseases, uncontrolled diabetics. d) Patient will be excluded if they had urinary tract infections (UTI), in urine microscopy.
  • the presence above of 10 leukocytes/mm3 of uncentrifuged urine or 10 leukocytes/hpf of the centrifuged sample, in a clinically suspected UTI.Patient with serum prostate specific antigen (PSA) > 10 nmol/ml. e) Vulnerable population – unconscious, too sick for consultation or ambulatory, differently abled, terminally ill patients, mentally incompetent people etc. f) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. g) Self-reported immune-compromised state, and already undergoing homoeopathic treatment for chronic disease within last 4 weeks. h) Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
International Consultation on Incontinence Questionnaire-UrinaryAt baseline, every month, up to 6 months
Incontinence Short Form (ICIQ-UI-SF) for incontinence of geriatric people.At baseline, every month, up to 6 months
Secondary Outcome Measures
NameTimeMethod
Quality of Life Scale (QOLS)At baseline, every month, up to 6 months

Trial Locations

Locations (1)

D N De Homoeopathic Medical College & Hospital

🇮🇳

Kolkata, WEST BENGAL, India

D N De Homoeopathic Medical College & Hospital
🇮🇳Kolkata, WEST BENGAL, India
Amit Gunin
Principal investigator
7044094135
amitgunin31@gmail.com

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