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临床试验/NCT06689813
NCT06689813已完成不适用

Effect of Vitamin D Supplementation on Severity of Stress Urinary Incontinence in Premenopausal Women With Vitamin D Insufficiency

Shalamar Institute of Health Sciences2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
to see the effect of vitamin supplementation on severity of urinary incontinence

研究概览

简要总结

The rationale for conducting the study is based on the fact that stress urinary incontinenc is a prevalent condition among middle age or older women and Vitamin D deficiency may have clinical effects on the pelvic floor muscles and bladder function. Therefore, the study aims to explore the potential link between vitamin D levels and SUI in women in our local population.

详细描述

The aging process is often associated with a gradual decline in muscle strength, including the weakening of pelvic floor muscles which are largely responsible for pelvic organ support and urinary retention. Weakness of these muscles is linked with urinary incontinence, the most frequently reported symptom of pelvic floor disorders. The most common type of urinary incontinence is stress urinary incontinence (SUI), which affects about 50% of women with increase in incidence with advancing age. The prevalence of stress urinary incontinence is approximately 23.58% in Pakistani middle aged women aged 40-50.

SUI occurs during times of elevated intraabdominal pressure (e.g., sneezing, coughing, and exercise). The levator muscles are responsible for supporting pelvic organs and maintaining the closure of the urethra. Strengthening the pelvic floor muscles through exercise and training is recommended as an effective treatment for SUI. The smooth and skeletal muscles throughout the body have vitamin D receptors. The pelvic floor muscles also express Vitamin D receptors, therefore Vitamin D insufficiency has shown asignificant association with pelvic floor dysfunction. Pelvic floor dysfunction includes symptoms of fecal incontinence, urinary incontinence and pelvic organ prolapse.

This study was conducted to see the association of vitamin D supplementation with improvement in stress incontinence symptoms.

Participants will be explained that their blood will be drawn twice in the study and they need to fill questionnaires with the help of principal investigator. They will be requested to sign a consent form and they will be assured that they can withdraw from the study at any time. SUI will be assessed by completing the standard ICIQ-SF (Incontinence Questionnaire - Urinary Incontinence Short) questionnaire at baseline and Serum concentrations of 25-hydroxy vitamin D will be tested by the ELISA immunoassay as per the protocol of the manufacturer.

The pateints will be divided into two groups by randomization. Group A ( intervention group) and group B (placebo group).All the patients in both groups will be advised pelvic floor exercises which is the standard first line management for stress urinary incontinence. Each study participant will be requested for 3ml of venous blood to determine their vitamin D3 levels. The treatment group will be asked to take vitamin D3 (cholecalciferol)(50,000IU) tablets, once a week, for 8 weeks and control group will be taking placebo ( isphagol husk capsules) weekly for 8 weeks. The research participants will be unaware of the type of preparation being given to them. The principal investigator will be aware of the preparation being given (single blind study).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria
  • Women age between 40-49 years
  • Women with SUI

排除标准

  • Using hormonal medications (estrogen supplementation)
  • Undergoing urogenital-related surgery (incontinence and prolapse surgery)
  • Diabetes Mellitus
  • Participants with any disorder that interferes with vitamin D absorption, such as inflammatory bowel disease, intestinal bypass surgery, or chronic liver or kidney disease
  • Neurological disease affecting the urinary system such as multiple sclerosis, degenerative muscle disease, spinal cord injury
  • Women with urinary tract infections
  • Women taking supplements ( multivitamins or already taking vitamin D supplementation)

结局指标

主要结局

to see the effect of vitamin supplementation on severity of urinary incontinence

时间窗: 0,4,8 and 12 weeks of treatment

Scoring of the stress urinary incontinence was done based on the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form Questionnaire. Severity of SUI was based on these scores, 1-5 (mild), 6-12 (moderate), 13-18 (severe), 19-21 (very severe).

次要结局

  • Impact on qulaity of life(0,4,8 and 12 weeks of treatment)

研究者

发起方
Shalamar Institute of Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheema Yousuf

second fellowship trainee in urogynaecology

Shalamar Institute of Health Sciences

研究点 (2)

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