Health Condition 1: null- Mixed urinary Incontinence Health Condition 2: N394- Other specified urinary incontinence
Conditions
Interventions
Intervention1: bisbasah plus pelvic floor muscle therapy (PFMT): Orally, Bisbasah powder (in capsules) 1.5 g twice daily for 12 weeks along with
PFMT for 12 weeks
Control Intervention1: placebo plus
Sponsors
National Institute of Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Parous women aged >=21 years with symptoms of MUI as evidenced by stress and urge symptoms reported on MESA (Medical, Epidemiologic and Social Aspects of Aging) questionnaire
Exclusion criteria
Exclusion criteria: 1. Women with known systemic and endocrine diseases such as uncontrolled hypertension, diabetes mellitus, bronchial asthma, known malignancies, 2. pregnant and lactating women were excluded. 3. Further incontinence of urine due to neurological defect, urinary tract infection, peripheral nerve disturbances, continuous leakage, post void residual urine volume >200ml, medication for urinary incontinence, and advanced uterine prolapse (grade >=3 by half way system).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was subjective improvement in symptoms of MUI measured with Patient Global Impression Index of Improvement (PGI-I) instrument and the Patient Global Impression Index of Severity (PGI-S).The safety assessment of the test drug included clinical examination and biochemical parameters (laboratory investigations) at baseline and follow-up (visit 6).Timepoint: third month and fourth month | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include change in symptom bother (Urogenital Distress Inventory Questionnaire-6 (UDI-6), and impact on womenâ??s QoL assessed by short form of IIQ-7, PISQ-12, and ICIQ-SF questionnairesTimepoint: third month and fourth month | — |
Countries
India
Contacts
Public ContactDr A G F Najeeya
National Institute of Unani Medicine
Outcome results
None listed