The purpose of this trial is to demonstrate the superior efficacy of pudendal neuromodulation in treating patients with neurogenic overactive bladder, who have failed conservative treatment, in a randomized cross-over trial.Symptoms of urinary…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean difference in functional bladder capacity, as measured by the average
voiding volume per episode, between stimulation ON for 4 weeks and OFF for 4
weeks.
Secondary outcome
The effect of pudendal neuromodulation (PNM) stimulation ON or OFF on:
• Urgency urinary incontinence as measured by the average number of
incontinence episodes per day.
• The maximum voided volume per episode
• Average number of voiding episodes per day
• Average number of urgency episodes per day
Assess therapy effects after 6 and 12 months of treatment:
• On functional bladder capacity as assessed by the average voiding volume per
episode
• On urgency urinary urine incontinence measured by the average number of
incontinence episodes per day.
• On the maximum voided volume per episode.
• On the average number of voiding episodes per day
• On the average number of urgency episodes per day
• On patient*s quality of life (Qualiveen)
• On bladder capacity as measured by urodynamics
• Collection of safety data
Explorative outcome measures:
• To assess the effect of therapy on patient*s general health using the EQ-5D
questionnaire
• To assess the effect of PNM on fecal constipation and fecal incontinence
• To assess the effect of PNM on sexual function
• To collect information on the direct medical resource use and cost impact of
the therapy on patients.
Background summary
Pelvic floor dysfunctions such as overactive bladder, urinary retention and
fecal incontinence affect millions of people worldwide. These conditions
seriously impair their quality of life and well-being. Neurogenic overactive
bladder with incontinence is secondary to confirmed pathology of the nervous
system. This is very difficult to treat and conservative methods often fail.
The 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.
Treatment of neurogenic overactive bladder by stimulation of the sacral nerve
is tested in small scale studies and reported with inconsistent degrees of
success.
The pudendal nerve is closer to the bladder, but has historically been
difficult to access, so limited clinical data is available. But with new
developments, the nerve is now accessible and treatment is minimally invasive.
Clinical data is promising, but is limited to a very small number of centers
and to case series.
Study objective
The purpose of this trial is to demonstrate the superior efficacy of pudendal
neuromodulation in treating patients with neurogenic overactive bladder, who
have failed conservative treatment, in a randomized cross-over trial.
Symptoms of urinary incontinence are compared per patient when stimulation is
switched on for 4 weeks to stimulation switched off for 4 weeks.
Study design
This is a prospective, interventional, randomized, crossover, post market
approval, multi-center study. The study will be conducted in 4 to 10 medical
centers in Europe. A minimum of 4 and a maximum of 12 patients will receive a
permanent implant at each site.
Up to 72 patients suffering from neurogenic overactive bladder, who have failed
conservative pharmacotherapy, will be screened and checked eligibility during
visit 1 and 2. Selected patients will will have implanted a tined lead at
visit 3 and undergo test stimulation period.
Patient who have successfully undergone test stimulation will receive an
implant at visit 5 and randomized in a 1:1 ratio to one of the two groups:
• Group ON/OFF: stimulation ON for 4 weeks, followed by stimulation OFF for 4
weeks;
• Group OFF/ON: stimulation OFF for 4 weeks, followed by stimulation ON for 4
weeks.
Patient will be recruited until a total of 36 patients have received the
implantable neurostimulator.
After this cross-over period, in which patients have to visit the hospital
twice, patients will have stimulation ON for the remainder of the study to 12
months post implant. During this period patients will be asked to visit the
hospital for 2 follow up visits. After the month 12 follow up visit, patients
will return to standard medical care.
Patient with unsuccessful test stimulation may undergo a second test
stimulation. All patients who do not have successful test stimulation will be
exited from the study and return to standard medical care. If the investigator
decides to continue with the neurostimulator implant, the patient will be
exited from the study without explanting the lead
Intervention
Patients who are, after screening, eligible for participation in the trial will
receive a lead implant at visit 3 to assess patient*s initial response to
pudendal neuromodulation. The position of the lead will be tested during acute
stimulation. Hereafter, a sub-chronic stimulation period (approximately 2 to 3
weeks) with home evaluation using a test stimulation will follow. The patient
has to complete a 5-day voiding diary.
Patients with successful test stimulation (defined as a minimum of 100 mL
increase from baseline in the functional bladder capacity calculated from the
voiding diary) will be implanted with the neurostimulator and randomized.
Study burden and risks
The burden for the patient consist of being implanted with a neurostimulator
during two surgeries. The main risks associated with these surgeries are
standard risks for surgical intervention (like wound infection and use of local
or general anesthesia).
There are also specific risks associated with the InterStim therapy on pudendal
neuromodulation. Possible risks are allergic reactions on the implanted
materials and incorrect functioning of the system after implantation. This
might affect the urinary, fecal or sexual function.
The InterStim therapy is CE marked which certifies that the therapy fulfills
all preclinical testing and safety requirements , and is justified for use in
human subjects.
Most important risks of the treatment are mentioned in the Information for
Prescribers InterStim Therapy manual and the Patient manual.
Additional burden for the patients are frequent study visits (maximum of 9
visits), including blood sampling, physical examination, collections of urine
during 5-days period, kidney ultrasounds and completion of patient*s
questionnaires
Route du Molliau, Case Postale
CH-1131,Tolochenaz
Zwitserland
Route du Molliau, Case Postale
CH-1131,Tolochenaz
Zwitserland
Listed location countries
Age
Inclusion criteria
• Eighteen years of age or older;
• Incomplete upper motor neuron lesion due to trauma or disease of the spinal cord (1 year post-lesion);
• Urodynamically proven overactive detrusor function;
• Minimum of 2 leaks or 2 notices of leaks per day (demonstrated on a 5-day voiding diary);
• Mean functional bladder capacity (volume voided per episode) of > 100mL;
• Normal upper urinary tract function as assessed by ultrasound imaging;
• Failed, intolerance or incomplete response to conservative pharmacotherapy;
• Failed or insufficient improvement of symptoms with conservative non pharmacotherapy treatment.
Exclusion criteria
• Complete spinal lesion or complete bilateral lesion of sacral/pudendal nerves;
• Primary stress incontinence or mixed incontinence where stress component overrides the urge component;
• Degenerative disease of the central nervous system;
• Urinary tract mechanical obstruction such as benign prostatic hyperthropy, cancer or urethral stricture.
• Symptomatic urinary tract infection
• Morphological abnormalities of the bladder
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30701.068.09 |
| Other | NTC01023269 |