An Open Labeled, Prospective, Multi-center, Clinical Study to Evaluate Efficacy and Safety of Leakless capsules in healthy Female participants with urinary incontinence.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assessment of bladder muscle tone and elasticity by evaluating change in severity of urinary incontinence symptoms on ICIQ-SF and participant diary
研究概览
简要总结
Itis an open labeled, prospective, multi-center, clinical study to evaluate efficacyand safety of Leakless capsules in healthy female participants with urinaryincontinence. The study will be carried out at 3 to 4 centers in India. Participantswill be given one capsule in the morning and evening after a meal with waterfor 12 weeks. The primary objective of the study will be to assess bladder muscle tone and elasticity byevaluating change in severity of urinary incontinence symptoms on ICIQ-SF andparticipant diary. The secondary objectives of the study will be to assess changesor difference in stress-induced urinary incontinence as per subject diary, changeor difference in frequency of nocturia as per subject diary, change or differencein frequency of daytime urination as per subject diary, change in urinaryincontinence- related quality of life, change in urinary symptoms related to femalelower urinary tract symptoms and impact on quality of life, change in sleepquality or efficiency as per subject diary, requirement of rescue medicationsas per subject diary, change in Global evaluation for overall change by subjectand investigator, tolerability of the study product by assessing adverse events,safety of study products through clinical and laboratory assessment and safetyEvaluation through assessments of adverse events on screening visit, week 1, week 2, week 4, weeks 8, week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
- •Participants complaining of involuntary loss of urine incontinence for 3 or more times during Day and night
- •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.
- •Participants are willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •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.
结局指标
主要结局
Assessment of bladder muscle tone and elasticity by evaluating change in severity of urinary incontinence symptoms on ICIQ-SF and participant diary
时间窗: Screening visit, week 1, week 2, week 4, weeks 8, week 12
次要结局
- 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.)