Fesoterodine fumarate for the treatment of neurogenic bladder

ISRCTN ISRCTN22433402
DOI https://doi.org/10.1186/ISRCTN22433402
Secondary identifying numbers 2287/23-3-2015
Submission date
24/05/2016
Registration date
02/06/2016
Last edited
18/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
An overactive bladder is a common condition in which the bladder muscle contracts too often or without warning. This causes the sufferer to feel the need to urinate more frequently and/or urgently, the need to get up in the night to urinate and in some cases, incontinence. Neurogenic detrusor overactivity (NDO) is where the overactive bladder has an underlying neurological (nervous system) cause. NDO is most commonly seen in people with multiple sclerosis (MS) or a spinal cord injury (SCI). This happens because changes and damage to the nerves involved in bladder activity can lead to involuntary contractions of the bladder muscle leading to urinary leaking. Fesoterodine is a medication which is used to treat overactive bladder. It works by blocking a chemical in the body which triggers the contractions of the bladder, causing the bladder muscle to relax. The aim of this study is to test the safety and efficiency of using Fesoterodine to treat patients with NDO.

Who can participate?
Adults with an overactive bladder as a result of MS or SCI.

What does the study involve?
After a period of two weeks in which no medication is taken (washout period), all participants receive 8mg Fesoterodine to take every day for three months. At the start of the study and again after the three months of treatment, participants undergo a test in order to find out how well their bladder is working. The test begins with the patient emptying their bladder into a special toilet to measure the amount of urine passed and the flow. Two very thin tubes (catheters) are then placed inside the bladder in order to monitor how it fills up (one tube fills up the bladder with liquid and the other measures the pressure). Once the bladder is full, x rays are taken, before the patient is asked to empty the bladder into the special toilet again with the tubes in place.

What are the possible benefits and risks of participating?
Participants benefit from receiving an in depth evaluation of how well their bladder is working, as well as receiving a treatment likely to help improve their bladder function and quality of life. There are no notable risks involved for participants in this study.

Where is the study run from?
National Rehabilitation Center, Athens (Greece)

When is the study starting and how long is it expected to run for?
March 2015 to March 2018

Who is funding the study?
National Rehabilitation Center, Athens (Greece)

Who is the main contact?
Dr Charalampos Konstantinidis

Contact information

Dr Charalampos Konstantinidis
Scientific

National Rehabilitation Center
Chasias Av. 8th bus stop & Spirou Theologou 1.
Ilion
Athens
13122
Greece

ORCiD logoORCID ID 0000-0002-4689-6899

Study information

Study designOpen label prospective non-randomised trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleEfficacy and safety of fesoterodine fumarate in neurogenic detrusor overactivity due to spinal cord lesion (SCL) or multiple sclerosis (MS)
Study objectivesThe aim of this study is to determine the safety and the efficacy of the use of Fesoterodine fumarate for the treatment of patients suffering from neurogenic detrusor overactivity (NDO).
Ethics approval(s)Scientific Committee of National Rehabilitation Center, 30/11/2015, ref: 9/9-12-2015
Health condition(s) or problem(s) studiedNeurogenic detrusor overactivity (NDO)
InterventionThere 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 simultaneously a 3 days bladder diary, and the SF-Qualiveen as a QoL questionnaire. Afterwards, all subjects will receive 8 mg Fesoterodine daily for 3 months. At the completion of this period they will undergo a second UDS completing also a second bladder diary and the SF-Qualiveen. Each UDS will be performed with the same equipment at the same environment from the same clinician, unaware of the study hypothesis, according to ICS’ standard good urodynamics practices and terms.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Fesoterodine fumarate
Primary outcome measureBladder 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 measuresNo secondary outcome measures.
Overall study start date27/03/2015
Completion date27/03/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants85
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/12/2015
Date of final enrolment10/12/2017

Locations

Countries of recruitment

  • Greece

Study participating centre

National Rehabilitation Center
Chasias Avenue
8th bus stop & Spirou Theologou 1
Ilion
Athens
13122
Greece

Sponsor information

National Rehabilitation Center
Hospital/treatment centre

Chasias Avenue, 8th bus stop & Spirou Theologou 1
13122, Ilion
Athens
13122
Greece

Website http://www.eka-hosp.gr

Funders

Funder type

Hospital/treatment centre

National Rehabilitation Center, Greece

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer reviewed journal
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 09/09/2021 02/03/2022 Yes No
Protocol file 18/08/2022 No No

Additional files

ISRCTN22433402_PROTOCOL.pdf

Editorial Notes

18/08/2022: Protocol file uploaded.
02/03/2022: Publication reference added.