Fesoterodine fumarate for the treatment of neurogenic bladder

Phase 4

Completed

• Conditions: eurogenic detrusor overactivity (NDO); Nervous System Diseases; Neurogenic detrusor overactivity (NDO)

• Registration Number: ISRCTN22433402
• Lead Sponsor: ational Rehabilitation Center

Brief Summary

2021 Results article in https://doi.org/10.1002/nau.24790 (added 02/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-02
• Study Completion: 2018-03-27
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
o secondary outcome measures.