Status:
TERMINATED
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
Lead Sponsor:
Wellspect HealthCare
Conditions:
Bladder Dysfunction
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00913510
Start Date
December 1 2009
End Date
May 1 2012
Last Update
November 11 2021
Active Locations (5)
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1
Centre Hospitalier Universitaire de Liège Ourthe Ambléve
Esneux, Belgium, 4130
2
UZ Gasthuisberg
Leuven, Belgium, 3000
3
St. Hedwig Hospital, Department of Urology
Berlin, Germany, 10115
4
UMC ST Radboud Nijmegen, Department of Urology
Nijmegen, Netherlands, 6500 HB