Clinical trial NCT01003249: Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Constipation
Lower Urinary Tract Symptoms
Keywords: over distention of bladder
Dysfunctional voiding
dysfunctional elimination syndrome
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

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. 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Urine Flow Rate, as Measured With Uroflometry
timeFrame: Baseline and 4 weeks
measure: Number of Participants Exhibiting Abnormal EMG Activity During Voiding
timeFrame: Baseline and 4 weeks
measure: Average Scores on International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
timeFrame: Baseline and 4 weeks
measure: Average Scores on Dysfunctional Voiding as Measured With Quality of Life (QOL) Questionnaire
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms.
timeFrame: Baseline and 4 weeks
measure: Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gopal Badlani, MD
role: PRINCIPAL_INVESTIGATOR
References: