Comparative study of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in neurogenic overactive bladder among supra-sacral spinal cord injury patients: An open label randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To compare effects of Solifenacin monotherapy in neurogenic overactive bladder in terms of clinical improvement of OAB symptoms after treatment at 4th & 8th weeks using OAB-V8 questionnaire.
研究概览
简要总结
Summary:
After fullfillment of inclusion & exclusion criterias , patients with supra-sacral spinal cord injury with neurogenic bladder reporting to the department of PM&R, AIIMS Jodhpur during the study period will be enrolled to give Solifenacin as monotherapy to control group versus Solifenacin with Duloxetine as combination therapy to the test group to compare the effectiveness & safety of solifenacin versus solifenacin with duloxetine. Comparatively solifenacin with duloxetine as combination therapy will be more effective over solifenacin as monotherapy in neurogenic overactive bladder among suprasacral spinal cord injury patients in terms of clinical improvement in OAB symptoms, improvement of urodynamic study parameters & overall quality of life.
Primary****Objective:
To compare effects of Solifenacin monotherapy in neurogenic overactive bladder in terms of clinical improvement of OAB symptoms after treatment at 4th & 8th weeks using OAB-V8 questionnaire.
Secondary****Objectives:
1. To compare effects of Solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy on urodynamic study parameters- MDP, LPP, PVR, TBC, DC at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients.
2. To compare the treatment impact on quality of life using OAB-qSF symptom bother & PHQ-9 questionnaires at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients.
3. To assess the safety profile by listing adverse effects of Solifenacin versus Solifenacin with Duloxetine in neurogenic overactive bladder among suprasacral SCI patients at 4th weeks & 8th weeks of treatment.
Purpose of the study :****Since there is no study available for neurogenic overactive bladder among suprasacral spinal cord injury patients comparing effectiveness & safety of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in terms of clinical improvement of OAB symptoms, urodynamic study (UDS) assessment , quality of life (QOL) assessment & overall drug safety in SCI patients.This study interpretation will be helpful in improving the management of neurogenic overactive bladder among suprasacral spinal cord injury patients & will impact the overall quality of life in such paraplegic disabled patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age- above 18 years of age till 65 years of age, of either sex.
- •2.Patients with neurogenic overactive bladder in last more than 3 months.
- •3.Diagnosed cases of supra-sacral SCI with or without paraplegia.
- •4.Supra-sacral SCI patients with indwelling catheter.
- •6.Supra-sacral SCI Patients on CIC.
- •7.Patients not taking any other medications for neurogenic bladder.
排除标准
- •1.PATIENTS WITH IMPAIRED HEPATIC OR RENAL FUNCTIONS 2.PATIENTS WITH UNCONTROLLED HYPERTENSION & NARROW ANGLE GALUCOMA 3.PATIENTS WITH COGNITIVE IMPAIRMENTS
- •PREGNANT & LACTATING FEMALES
- •PATIENTS WITH NEUROPSYCHIATRIC DISORDER 6.PATIENTS WITH BLADDER STONE,UTI,HYDROURETERONEPHROSIS 7.PATIENTS TAKING OTHER MEDICINES FOR NEUROGENIC BLADDER.
结局指标
主要结局
To compare effects of Solifenacin monotherapy in neurogenic overactive bladder in terms of clinical improvement of OAB symptoms after treatment at 4th & 8th weeks using OAB-V8 questionnaire.
时间窗: Baseline visit at week 1st | 2nd visit at week 4th & | 3rd visit at week 8th
次要结局
- 1.To compare effects of Solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy on urodynamic study parameters- MDP, LPP, PVR, TBC, DC at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients.
研究者
Dr Rejuwan Hussain
AIIMS JODHPUR