Constipation Clinical Trial
Official title:
Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial
Dysfunctional voiding is often associated with constipation. The association of constipation
with urologic pathologic processes has previously been described since the 1950's, but it was
only over the past decade that clinicians have paid more attention to this relationship and
recognized it existence with the term dysfunctional elimination syndrome (DES). This term is
used to reflect the broad spectrum of functional disturbances that may affect the urinary
tract including that of functional bowl disturbances and can be classified as follows:
- Functional disorder of filling: overactive bladder, over distention of bladder or
insensate bladder, which may be associated with fecal impaction or rectal distention
with infrequent bowel movements
- Functional disorder of emptying: over-recruitment of pelvic floor activity during
voiding causing interrupted and/or incomplete emptying also associated with defecation
difficulties due to non- relaxation of the puborectalis muscle, dyssynergic defecation
or pain with defecation Several different therapeutic options have been used for
patients with dysfunctional voiding mainly to decrease bladder outlet obstruction. These
treatments including, alpha adrenergic antagonists, and botulinum toxin are less than
optimum. One possible explanation for these drug failures includes the inability of
these medications to relax the striated muscles of the pelvic floor necessary for
voiding.
To date there has been no data to evaluate the role of baclofen on the striated muscle of the
external anal sphincter, essential in the defecation process.
Outcome Measure(s)
1. Efficacy of baclofen vs. placebo on dysfunctional voiding as measured with uroflometry
and EMG; patients' symptoms score questionnaires and diaries.
2. Efficacy of baclofen vs. placebo on the external anal sphincter muscle dysfunction via
patient symptoms and questionnaire.
3. The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory).
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