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Fesoterodine fumarate for the treatment of neurogenic bladder

Efficacy and safety of fesoterodine fumarate in neurogenic detrusor overactivity due to spinal cord lesion (SCL) or multiple sclerosis (MS)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22433402
Enrollment
85
Registered
2016-06-02
Start date
2015-12-10
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Neurogenic detrusor overactivity (NDO) Nervous System Diseases Neurogenic detrusor overactivity (NDO)

Interventions

There will be a 2 week wash-out period prior to enrollment for patients under drug medication for the treatment of NDO. All patients will undergo a first confirmatory baseline UDS, completing simultan

Sponsors

National Rehabilitation Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18-80 years old 2. Suffering from neurogenic detrusor overactivity, confirmed by urodynamics testing, secondary to MS or SCI of at least 6 months prior to enrollment 3. Patients suffering from MS should be clinically stable for at least 3 months prior to enrollment

Exclusion criteria

Exclusion criteria: 1. UTI 2. History of urothelial cancer 3. Urolithiasis 4. Stress incontinence 5. Interstitial cystitis 6. Pelvic organ prolapsed (= III grade) 7. Prior pelvic surgery or pelvic radiation treatment 8. Uncontrolled narrow angle glaucoma 9. Pregnancy 10. Dementia

Design outcomes

Primary

MeasureTime frame
Bladder function will be evaluated using Urodynamics Testing (UDS), a three day bladder diary and the SF-Qualiveen questionnaire at baseline and three months.

Secondary

MeasureTime frame
No secondary outcome measures.

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026