Status:
TERMINATED
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Overactive Bladder
Constipation
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01003249
Start Date
September 1 2009
End Date
March 1 2013
Last Update
August 14 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157