Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
Information source: Wake Forest University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder; Constipation; Lower Urinary Tract Symptoms
Intervention: Baclofen (Drug); Placebo Comparator: Placebo (Drug)
Phase: Phase 4
Sponsored by: Wake Forest University
Official(s) and/or principal investigator(s):
Gopal Badlani, MD, Principal Investigator, Affiliation: Wake Forest University
Rachel Shertzer-Skinner, Phone: 336-716-4131
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
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.
Official title: Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Efficacy of baclofen vs. placebo on dysfunctional voiding as measured with uroflometry and EMG; patients' symptoms score questionnaires and diaries.
Efficacy of baclofen vs. placebo on the external anal sphincter muscle dysfunction via patient symptoms and questionnaire.
The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory).
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).
Minimum age: 18 Years.
Maximum age: 64 Years.
- Adult men and women (>18 years old, <65 years old)
- Patients with lower urinary tract symptoms (hesitancy, intermittency decreased force
and caliber of urinary stream, urgency, incontinence) and urodynamic finding
compatible with diagnosis of DV in multichannel videourodynamics. (Non relaxation or
over stimulation of EMG activity, and stress pattern of voiding)
- Established symptoms for at least six months
- Patients with defecatory symptom should have symptoms of constipation (must include 2
or more of the following: straining during 25% of defecations, hard or lumpy stools
during 25% of defecation, sensation of incomplete evacuation upon defecations,
sensation of anorectal blockage or obstruction during 25% of defecations, manual
maneuvers to facilitate 25% of defecations; loose stools that are rarely present
without the use of laxatives; insufficient criteria to meet the definition of IBS-C.
- Overt neurogenic disease
- Significant bladder outlet obstruction
- Detrusor instability on Urodynamic study
- Detrusor hypo contractility due to neurogenic causes
- Previous pelvic radiation
- Present (and past) malignancy of bladder or prostate
- Present or recurrent UTI (3 or more documented UTI in the past year )
- Interstitial Cystitis
- Diabetic neuropathy
- Patients on anticholinergic medications
- Bladder stones
- Urinary retention
- Underlying dementia or significant cognitive impairment.
- Patients unwilling to undergo videourodynamic , EMG or anorectal manometry testing
- Sample size: 62 patients in total (calculation basis described on Statistical Plan
for Data Analysis)
Locations and Contacts
Rachel Shertzer-Skinner, Phone: 336-716-4131
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Gopal Badlani, MD, Principal Investigator
Starting date: September 2009
Last updated: October 26, 2009