Constipation Clinical Trial
Official title:
Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine Flow Rate, as Measured With Uroflometry | Uroflometry with patch electrodes will also be completed at the end of this four week period. Higher flow rate denotes better outcome. | Baseline and 4 weeks | |
Primary | Number of Participants Exhibiting Abnormal EMG Activity During Voiding | EMG with patch electrodes was completed at the end of this four week period. The number of participants with EMG activity during voiding was collected. EMG activity during the voiding is considered abnormal and is a criteria for voiding dysfunction.Lower numbers denotes better outcomes. | Baseline and 4 weeks | |
Primary | Average Scores on International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | Diagnosis of dysfunctional bladder is based on symptoms demonstrating no relaxation or over stimulation of external urinary sphincter during voiding. Symptoms will be scored by International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). The ICIQ-LUTSqol is a patient-completed questionnaire for evaluating quality of life (QoL) in urinary incontinent patients There are 20 items and the score range is 10-200. Higher scores denotes better outcomes. | Baseline and 4 weeks | |
Primary | Average Scores on Dysfunctional Voiding as Measured With Quality of Life (QOL) Questionnaire | This was measured using the Urogenital Distress Inventory (UDI-6). The UDI-6 is a symptom inventory specific to lower urinary tract dysfunction and genital prolapse. There are 6 items scored. The score range is from 0-100 Lower scores denotes better outcomes. | Baseline and 4 weeks | |
Secondary | Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms. | The percent of patient in each group who had defecation problem | Baseline and 4 weeks | |
Secondary | Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day | The number of voiding per day before and after treatment. | Baseline and 4 weeks |
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