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临床试验/CTRI/2023/11/060039
CTRI/2023/11/060039尚未招募1 期

Effect of unsupervised pelvic floor muscle training on urodynamic profile among individuals with neurogenic bladder following spinal cord injury: A Pilot Randomized Controlled Trial

Shivani Shrikrishnavilas wattamwar1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月27日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Urodynamics

研究概览

简要总结

This study attempts to examine the effect of unsupervised pelvic floor muscle training among individuals with neurogenic bladder following spinal cord injury. ASIA Scale will be used as screening tool. Primary outcome is Urodynamic study in which pre and post intervention values will be compared among intervention and compatator groups. Secondary outcomes are neurogenic bladder symptom score(NBSS), Overactive bladder symptom score scale(OABSS) and bladder diary. Bladder diary will be maintained to record frequency, urgency. NBSS and OABSS will be assessed pre and post intervention and progression of urinary symptoms will be tracked. Pelvic floor muscle exercises will be taught to the intervention group along with standard care until they understand and able to perform and will be called to OPD if they face any problems. Follow up will be taken twice a week through phone calls. Comparator group will be taught standard care. All the outcomes will be assessed after 3 months of intervention. The data will be statistically analysed and result will be drawn.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Spinal cord injury patients with neurogenic bladder 2) Patients recovered from the spinal shock 3) Both male and female 4) Patients having ASIA score C or D.
  • Patient who are able to understand simple commands.

排除标准

  • Neurogenic bladder associated with other neurological conditions.
  • Individuals having bladder dysfunction prior to spinal cord injury 3) Patients having other complications like urinary tract infection, hydronephrosis, kidney stones, etc.

结局指标

主要结局

Urodynamics

时间窗: 3 months

次要结局

  • ASIA, Neurogenic bladder symptom score (NBSS) scale, overactive bladder symptom score (OABSS), Bladder Diary(3 months)

研究者

发起方
Shivani Shrikrishnavilas wattamwar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shivani Shrikrishnavilas Wattamwar

MGM Institute of Physiotherapy

研究点 (1)

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