Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
Condition: Overactive Bladder; Constipation; Lower Urinary Tract Symptoms
MeSH terms: Urinary Bladder, Overactive; Constipation; Lower Urinary Tract Symptoms
Intervention: Baclofen; Placebo
Intervention description: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). After the 3 week washout period, questionnaires, diary, EMG and uroflowmetry will be repeated. Then patients initially assigned to the baclofen group will be assigned to the placebo group, and those assigned to the placebo group will be assigned to the baclofen group.
Patients would then receive a dose of baclofen 10 mg PO twice daily (or placebo twice daily), and then the dose will be escalated to 80 mg.; Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). After the 3 week washout period, questionnaires, diary, EMG and uroflowmetry will be repeated. Then patients initially assigned to the baclofen group will be assigned to the placebo group, and those assigned to the placebo group will be assigned to the baclofen group.
Patients would then receive a dose of baclofen 10 mg PO twice daily (or placebo twice daily), and then the dose will be escalated to 80 mg.
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: over distention of bladder; Dysfunctional voiding; dysfunctional elimination syndrome

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.
    

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)