Bladder Cancer Clinical Trial
Official title:
Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study
A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.
In appropriately selected patients an orthotopic neobladder (ONB) permits the elimination of
an external stoma and preservation of body image without compromising cancer control after
radical cystectomy. Voiding dysfunction (VD) following ONB can be divided into failure to
empty bladder or failure to store urine. Failure to empty bladder by angulation of urethra is
the most common cause. Failure to store urine can occur during daytime, night-time or both.
VD that persists beyond 6 to 12 months warrants urodynamics evaluation to determine the cause
and suggest plane of therapy. Voiding dysfunction has a detrimental impact on quality of
life.
Among the various bowel segments studied, the ileum is ideal for ONB creation. A spherical
reservoir, reconfigured from a de-tubularized ileal segment, offers the most desirable
attributes like, adequate capacity, low intraluminal pressure, and good compliance. The
patient of ONB reported 4-25% rate of clean intermittent self-catheterisation (CISC) for
incomplete emptying. Daytime incontinence was present in 13% of patients. The rate of
nocturnal incontinence is usually higher in the range of 15-40% in recent metanalysis. The
success of ONB rely on detubularization of intestinal segment, sufficient capacity and proper
configuration and position in the pelvis. Adequate capacity is achieved by using sufficient
length, folding, and creation an ellipsoid or spherical configuration. The ONB should hold
approximately 500 cc of urine at low pressure (at < 15 cm H2O), empty completely (< 100 cc
urine), four to five times daily and allow the patient to sleep without awakening, while
maintain normal body image
loss of the vesico-urethral reflex 'guarding reflex' in which increased urethral sphincter
tone parallel to bladder distension, decreased patient vigilance during sleep resulting in
reduced muscle tone and urethral closing pressure, decreased sensitivity of the membranous
urethra after radical cystectomy, involuntary high-amplitude contractions of the reservoir
secondary to bowel peristalsis and shifting of free water from the reservoir wall into the
hyperosmolar urine are the main factor causing global and nocturnal polyuria in patient with
ONB. Final, there is also evidence suggesting an increase in bowel activity during sleep.
Maximum urethral closing pressure (MUCP) is the primary component responsible for daytime
continence in patients with an ONB. However, Koraitim et al. suggest that nocturnal
incontinence depends on three reservoir parameters: maximal contraction amplitude, baseline
reservoir pressure at mid capacity, and MUCP.
Mebeverine is a derivative of reserpine, which has relatively specific effects on smooth
muscle cells without atropine-like side effects in humans. It directly blocks
voltage-operated sodium channels and inhibits intracellular calcium accumulation. It is three
times more potent than papaverine in inhibiting the peristaltic reflex of the ileum.
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