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recruitment was going too slowly
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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:
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.
Outcome Measure(s)
3. The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen, Then Placebo | Active Comparator | 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. There will be a washout period after three week. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). 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 |
|
| Placebo, Then Baclofen | Placebo Comparator | 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. There will be a washout period after three week. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gopal Badlani, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baclofen, Then Placebo | Participants first received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks). This was followed by a 3 week washout period and then 4 weeks of Placebo. |
| FG001 | Placebo, Then Baclofen | Participants received Placebo for 4 weeks, followed by a 3 week washout period. Participants then received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Washout (3 Weeks) |
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| Second Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Includes all participants in the study. Participants were randomized to either study drug or placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ml/s | Baseline and 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychosis | Psychiatric disorders | Systematic Assessment | flare up in psychosis history of subject |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Symptoms | Gastrointestinal disorders | Systematic Assessment | Common GI symptoms: bloating, upset stomach, nausea, etc..All GI Symptoms were collected/recorded under a single adverse event term |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gopal Badlani | Wake Forest University Health Sciences | 3367165928 | gbadlani@wakehealth.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D003248 | Constipation |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Placebo | Drug | 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. |
|
The number of voiding per day before and after treatment. |
| Baseline and 4 weeks |
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| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| 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). 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). |
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|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | number of voids | Baseline and 4 weeks |
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|
| 0 |
| 12 |
| 1 |
| 12 |
| 1 |
| 12 |
| EG001 | 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). 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). | 0 | 12 | 0 | 12 | 2 | 12 |
|
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| Excessive Sleepiness | General disorders | Systematic Assessment |
|
| Feeling too loose | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |