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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Timeframe: Baseline and 8 weeks after randomization.