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
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
Scientific
National Rehabilitation Center
Chasias Av. 8th bus stop & Spirou Theologou 1.
Ilion
Athens
13122
Greece
 ORCID ID |
0000-0002-4689-6899 |
|---|
Study information
| Study design | Open label prospective non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Efficacy and safety of fesoterodine fumarate in neurogenic detrusor overactivity due to spinal cord lesion (SCL) or multiple sclerosis (MS) |
| Study objectives | The 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) studied | Neurogenic detrusor overactivity (NDO) |
| Intervention | 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 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Fesoterodine fumarate |
| Primary outcome measure | 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 | No secondary outcome measures. |
| Overall study start date | 27/03/2015 |
| Completion date | 27/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 85 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/12/2015 |
| Date of final enrolment | 10/12/2017 |
Locations
Countries of recruitment
- Greece
Study participating centre
8th bus stop & Spirou Theologou 1
Ilion
Athens
13122
Greece
Sponsor information
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
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | Not 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
Editorial Notes
18/08/2022: Protocol file uploaded.
02/03/2022: Publication reference added.
