Clinical trial NCT00913510: Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
Official title: Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Dysfunction
Multiple Sclerosis
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Male and female patients aged 18 years and over
* MS patients that are already currently treated or eligible for treatment with anticholinergic drugs
* Patient with previously confirmed multiple sclerosis according to McDonald Criteria and level of disability less than 6.5 on the Kutzke scale and have been stable for 6 months
* The patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, PVR
* The patient has Frequency symptoms \> 8 voiding per 24 h
* The patient has PVR \> 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
* Adequate mobility to lower limbs, sufficient hand function and ability to practice CIC at least three times daily

Exclusion Criteria:

* Pregnancy
* Ongoing symptomatic Urinary Tract Infection (UTI) as judged by investigator
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* The patient practices CIC prior the study
* The patient has undergone a sphincterectomy
* Progressive "Relapsing- remitting MS" as judged by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* The patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
* PVR \> 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if Bladder Voiding Efficiency (BVE) at visit 2 (randomization) is 50% or less than visit 1 (screening)

Primary outcomes:
measure: Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
timeFrame: Baseline and 8 weeks after randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Esneux
country: Belgium
facility: Centre Hospitalier Universitaire de Liège Ourthe Ambléve
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Berlin
country: Germany
facility: St. Hedwig Hospital, Department of Urology
city: Nijmegen
country: Netherlands
facility: UMC ST Radboud Nijmegen, Department of Urology
city: London
country: United Kingdom
facility: University College of London, Institute of Neurology
Study officials:
affiliation: University College, London
name: Clare Fowler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: