FindTrial
Sign In

A clinical trial to study the comparative effects of two drugs solifenacin & duloxetine for the patients with spinal cord injury & its effects on neurogenic overactive bladder.

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. - IRB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077322
Enrollment
52
Registered
2024-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G952- Other and unspecified cord compression

Interventions

Intervention1: SOLIFENACIN MONOTHERAPY VERSUS SOLIFENACIN WITH DULOXETINE AS COMBINATION THERAPY: Intervention: To give Solifenacin 5 mg once daily after breakfast as monotherapy to control group or g

Sponsors

DR REJUWAN HUSSAIN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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. 5.Supra-sacral SCI patients with self-voiding bladder. 6.Supra-sacral SCI Patients on CIC. 7.Patients not taking any other medications for neurogenic bladder.

Exclusion criteria

Exclusion criteria: 1.PATIENTS WITH IMPAIRED HEPATIC OR RENAL FUNCTIONS 2.PATIENTS WITH UNCONTROLLED HYPERTENSION & NARROW ANGLE GALUCOMA 3.PATIENTS WITH COGNITIVE IMPAIRMENTS 4. PREGNANT & LACTATING FEMALES 5. PATIENTS WITH NEUROPSYCHIATRIC DISORDER 6.PATIENTS WITH BLADDER STONE,UTI,HYDROURETERONEPHROSIS 7.PATIENTS TAKING OTHER MEDICINES FOR NEUROGENIC BLADDER

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline visit at week 1st 2nd visit at week 4th & 3rd visit at week 8th—

Secondary

MeasureTime frame
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.Timepoint: Baseline visit at 1st week 2nd visit at 4th weeks & 3rd visit at 8th weeks—

Countries

India

Contacts

Public ContactDr Ravi Gaur

AIIMS JODHPUR

ravisms80@gmail.com8299711753

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026