NCT00913510

Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction

Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aims of this prospective, randomized study are: * To assess the effect of clean intermittent catheterization (CIC) * To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs * To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL * To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients

Conditions

• Bladder Dysfunction
• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	CIC using LoFric Primo	Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
DRUG	Anticholinergic medication	Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-06-04
• Last updated: 2021-11-11
• Results posted: 2014-01-06

Locations

5 sites across 4 countries: Belgium, Germany, Netherlands, United Kingdom