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Prospective, multi-center, randomized, double-blind sham-controlled trial of the urinary dysfunction treatment device O-NES in patients with refractory overactive bladder with urinary incontinence (pivotal trial)

Double-blind sham-controlled trial of the urinary dysfunction treatment device O-NES in patients with refractory overactive bladder

Mukai Yoichi

Otsuka Techno Corporation

120-1, Aza Itayashima, Akinokami, Seto-cho, Naruto, Tokushima

mukaiy@otsuka.jp

Mukai Yoichi

Otsuka Techno Corporation

120-1, Aza Itayashima, Akinokami, Seto-cho, Naruto, Tokushima

+81-88-683-7111

mukaiy@otsuka.jp

Not Recruiting

Oct. 18, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-They are aged 20 years or older at the time they give their informed consent.
-They have been treated with anticholinergic drugs and beta3 receptor agonists in the past, but the symptoms of overactive bladder are persisting or they cannot use therapeutic drugs of overactive bladder due to certain reasons such as contraindications.
-They have 2 points or higher of urinary urgency score (question 3) and 2 points or higher of urgency urinary incontinence score (question 4) in OABSS.
-Their mean urinary incontinence with urinary urgency per day is 1 time or more and their mean urinary frequency per day is 8 times or more.
-They have will and able to accurately record the urinary diary and complete the questionnaire throughout the trial period.

-They wear any implantable electronic device (e.g. pacemaker).
-They have been treated with neuromodulation therapy (electrical stimulation, magnetic stimulation, etc.) for overactive bladder.
-They have a history of treatment with botulinum toxin for the bladder.
-They started treatment with the following drugs within 4 weeks prior to informed consent (including new, resumption, or drug switching): Alternatively, the dosage and administration were changed or discontinued.
1) Anticholinergic drugs or beta3 receptor agonists used for the purpose of improving the symptoms of overactive bladder
2) alpha1-blockers or PDE-5 inhibitors used to improve the symptoms of benign prostatic hyperplasia.
-They were diagnosed with stress urinary incontinence as the main symptom of urinary incontinence.
-They have urinary dysfunction, nocturnal enuresis, inflammatory diseases of the lower urinary tract (interstitial cystitis, bacterial cystitis, prostatitis, etc.), urinary stone (urethral stone, bladder stone, ureteral stone).
-They have a history of surgery to remove a malignant tumor in the pelvis.
-They have treatment-requiring pelvic organ prolapse or have a history of pelvic organ prolapse surgery within 6 months before informed consent.
-They have residual urine volume of exceeding 100 mL or have mechanical (organic) obstruction in the lower urinary tract or have clinically problematic lower urinary tract obstruction disease (such as benign prostatic hyperplasia).
-They are carrying out indwelling catheterization or intermittent self-catheterization.
-They have symptoms of overactive bladder of neurological cause.

Both

Overactive bladder

Therapeutic intervention is carried out after baseline screening. The safety is confirmed after the end of therapeutic intervention.

The change in the mean frequency of urinary incontinence episodes per day from the baseline in the treatment fourth week.

-The rate of change in the mean frequency of urinary incontinence episodes per day from the baseline.
-The mean daily urinary frequency and its change from the baseline.
-The rate of change in the mean daily urinary frequency from the baseline.
-The mean daily urinary urgency and its change from the baseline.
-The rate of change in the mean daily urinary urgency from the baseline.
-The change in the total Overactive Bladder Symptom Score (OABSS) from the baseline.
-The mean voided volume per micturition and its change from baseline.
-The maximum voided volume per micturition and its change from the baseline.

+81-3-5802-1584

Oct. 06, 2021

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