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Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis?

Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? - Alpha blockers and Multiple Sclerosis (MS)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47090
Enrollment
30
Registered
2016-01-21
Start date
2016-02-11
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Bladder dysfunction in MS bladder dysfunction in Multiple Sclerosis

Interventions

One group receives the alpha blocker Silodosin during 6 weeks while the second group is treated with placebo during the same period.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female - Age >= 18 years - Any form of MS - Residual urine 60 ml - 250 ml - Adequate understanding of the Dutch language

Exclusion criteria

Exclusion criteria: - Dependency of wheel chair - Being bedridden - Indwelling catheter - Clean intermittent catheterization - Acute attack of MS - Current treatment with an alpha-blocker - Pregnancy/breastfeeding - Severe kidney dysfunction - Orthostatic hypotension

Design outcomes

Primary

MeasureTime frame
Residual urine, measured within 10 minutes after a voluntary void at t=0 and t=6 weeks.

Secondary

MeasureTime frame
- Quality of life (questionnaire: Qualiveen) at t=0 and t=6 weeks. - Symptom scores of voiding complaints (questionnaires: UDI-6 and IIQ-7) at t=0 and t=6 weeks.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)