Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

This study has been terminated.
(recruitment was going too slowly)
Sponsor:
Information provided by (Responsible Party):
Gopal Badlani, MD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01003249
First received: October 21, 2009
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Constipation
Lower Urinary Tract Symptoms
Drug: Baclofen
Drug: Placebo Comparator: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Efficacy of baclofen vs. placebo on dysfunctional voiding as measured with uroflometry and EMG; patients' symptoms score questionnaires and diaries. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of baclofen vs. placebo on the external anal sphincter muscle dysfunction via patient symptoms and questionnaire. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory). [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Baclofen
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).
Drug: Baclofen
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).
Placebo Comparator: Placebo
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).
Drug: Placebo Comparator: Placebo
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).

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003249

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Gopal Badlani, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Gopal Badlani, MD, MD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01003249     History of Changes
Other Study ID Numbers: IRB00009516
Study First Received: October 21, 2009
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
over distention of bladder
Dysfunctional voiding
dysfunctional elimination syndrome

Additional relevant MeSH terms:
Constipation
Urinary Bladder, Overactive
Signs and Symptoms, Digestive
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014