Detrusor Overactivity, Neurogenic Overactive Bladder, Urinary Incontinence
Conditions
Keywords
Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity
Brief summary
The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.
Detailed description
The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems. This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.
Interventions
DEVICEInterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Incomplete upper motor neuron lesion * Detrusor overactivity * Two leaks or two notices of leaks per day * Mean functional bladder capacity (volume voided per episode) of ≥100 ml
Exclusion criteria
* Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves. * Degenerative disease of the central nervous system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Bladder Capacity | Baseline, 4 weeks after implant, 8 weeks after implant | Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups. |
Countries
Belgium, France, Germany, Italy, Netherlands, United Kingdom
Participant flow
Pre-assignment details
17 patients were included in the study: 9 patients did not pass the test stimulation period, 1 patient dropped out due to exclusion criteria, 1 patient dropped out due to protocol deviation during screening visit, 1 patient dropped out before test stimulation due to early termination of the study, leaving 5 patients who were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Total Patient The patient demographic were analysed without splitting by study intervention since all randomized subjects were to receive both stimulation options (ie, ON and OFF). | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | early termination of the study | 2 | 0 |
Baseline characteristics
| Characteristic | Total Patient |
|---|---|
| Age, Continuous | 41.60 year STANDARD_DEVIATION 14.81 |
| Region of Enrollment Belgium | 2 participants |
| Region of Enrollment France | 1 participants |
| Region of Enrollment Italy | 1 participants |
| Region of Enrollment United Kingdom | 1 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 7 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Functional Bladder Capacity
Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
Time frame: Baseline, 4 weeks after implant, 8 weeks after implant
Population: Due the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Randomized Patients | Functional Bladder Capacity | Baseline | 186.02 ml | Standard Deviation 38.15 |
| All Randomized Patients | Functional Bladder Capacity | 4 weeks after impalnt | 367.16 ml | Standard Deviation 201.17 |
| All Randomized Patients | Functional Bladder Capacity | 8 weeks after implant | 346.07 ml | Standard Deviation 177.98 |