Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Baclofen

Placebo

About this trial

This is an interventional basic science trial for Overactive Bladder focused on measuring over distention of bladder, Dysfunctional voiding, dysfunctional elimination syndrome

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Baclofen, Then Placebo

Placebo, Then Baclofen

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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

Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day

The number of voiding per day before and after treatment.

Full Information

NCT ID

NCT01003249

First Posted

October 21, 2009

Last Updated

July 16, 2018

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01003249

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

recruitment was going too slowly

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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) Efficacy of baclofen vs. placebo on dysfunctional voiding as measured with uroflometry and EMG; patients' symptoms score questionnaires and diaries. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Constipation, Lower Urinary Tract Symptoms

Keywords

over distention of bladder, Dysfunctional voiding, dysfunctional elimination syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baclofen, Then Placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo, Then Baclofen

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Baclofen

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urine Flow Rate, as Measured With Uroflometry

Description

Uroflometry with patch electrodes will also be completed at the end of this four week period. Higher flow rate denotes better outcome.

Time Frame

Baseline and 4 weeks

Title

Number of Participants Exhibiting Abnormal EMG Activity During Voiding

Description

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.

Time Frame

Baseline and 4 weeks

Title

Average Scores on International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

Description

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.

Time Frame

Baseline and 4 weeks

Title

Average Scores on Dysfunctional Voiding as Measured With Quality of Life (QOL) Questionnaire

Description

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.

Time Frame

Baseline and 4 weeks

Secondary Outcome Measure Information:

Title

Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms.

Description

The percent of patient in each group who had defecation problem

Time Frame

Baseline and 4 weeks

Title

Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day

Description

The number of voiding per day before and after treatment.

Time Frame

Baseline and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gopal Badlani, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Overactive Bladder, Constipation, Lower Urinary Tract Symptoms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial