Health Condition 1: N394- Other specified urinary incontinence
Conditions
Interventions
Intervention1: Leakless Capsules: One capsule in the morning and evening after a meal with water for 12 weeks.
Control Intervention1: NIL: NIL
Sponsors
Transformative Learning Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Female participants complaining of involuntary loss of urine incontinence persisting for at least 1 month as determined by a score greater than or equal to 5 on the ICIQ-SF questionnaire at the screening visit. 2. Participants complaining of involuntary loss of urine incontinence for 3 or more times during Day and night 3. Female participant not having child-bearing potential (defined as females who have undergone a sterilization procedure like hysterectomy, bilateral oophorectomy, bilateral tubal ligation etc. or have been post-menopausal (natural or surgically) for at least 1 year prior to screening. 5. Participants are willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Female undergoing any hospitalized treatment. 2. Participants with BMI less than 18.5 or greater than 35.0 kg per meter square. 3. Participants currently participating or having participated in any other investigational clinical trial within the last 30 days prior to screening. 4. Participants with history of or current severe medical conditions, such as uncontrolled hypertension, diabetes mellitus, thyroid, chronic kidney disease, heart disease, or severe hepatic impairment 5. Participants with neurological conditions like multiple sclerosis, Parkinson disease, spinal cord injuries, or stroke. 6. Females who are pregnant, lactating, or planning to become pregnant during the study period. 7. Participants with active or recurrent urinary tract infections within 30 days prior of screening 8. Participants who have undergone previous surgical interventions for urinary incontinence within the past 12 months. 9. History of interstitial cystitis, bladder cancer, bladder stones, or any major urological condition requiring intervention within the past 6 months. 10. Known hypersensitivity or allergy to the ingredients of the study product 11. Participants on medications like diuretics, anticholinergics, or alpha-blockers, unless they have been on a stable dose for at least 3 months prior to screening. 12. Participants with current or past 12 month history of drug abuse or alcohol dependency, as well as the use of recreational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of bladder muscle tone and elasticity by evaluating change in severity of urinary incontinence symptoms on ICIQ-SF and participant diaryTimepoint: Screening visit, week 1, week 2, week 4, weeks 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes or difference in stress-induced urinary incontinence as per subject diary 2. Assessment of change or difference in frequency of nocturia as per subject diary. 3. Assessment of change or difference in frequency of daytime urination as per subject diary. 4. Assessment of change in urinary incontinence- related quality of life 5. Assessment of change in urinary symptoms related to female lower urinary tract symptoms and impact on quality of life 6. Assessment of change in sleep quality or efficiency as per subject diary. 7. Assessment of requirement of rescue medications as per subject diary 8. Change in Global evaluation for overall change by subject and investigator 9. Assessment of tolerability of the study product by assessing adverse events 10. Safety of study products through clinical and laboratory assessment 11. Safety Evaluation through assessments of adverse events. Timepoint: Screening visit, week 1, week 2, week 4, weeks 8, week 12 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Transformative Learning Solutions Pvt Ltd
Outcome results
None listed