Overactive BladderPhase 4NCT01003249
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
A Phase 4 study testing Baclofen in people with Overactive Bladder and Constipation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Overactive Bladder, Constipation, Lower Urinary Tract Symptoms
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial
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.
Read the 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.
- The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory).
- Being tested
- Baclofen, Placebo
- Keywords
- over distention of bladder, Dysfunctional voiding, dysfunctional elimination syndrome
- Medical subject headings
- Urinary Bladder, Overactive, Constipation, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Baclofen; Drug: Placebo |
| 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 Receives: Drug: Baclofen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
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
Measured: Baseline and 4 weeks
Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day
The number of voiding per day before and after treatment.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: recruitment was going too slowly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gopal Badlani, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003249
- Sponsor's protocol ID
- IRB00009516
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2009
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen: a Randomized Double-blind Placebo-controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT01003249
- Acronym / sponsor ID
- IRB00009516
- Keywords
- over distention of bladder, Dysfunctional voiding, dysfunctional elimination syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment was going too slowly
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The safety of baclofen in patients with dysfunctional voiding (urinary and defecatory).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen, Then Placebo | Active comparator | Drug: Baclofen, Drug: PlaceboSubjects 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 | Drug: Baclofen, Drug: PlaceboSubjects 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- Overt neurogenic disease
- Significant bladder outlet obstruction
- Detrusor instability on Urodynamic study
- Detrusor hypo contractility due to neurogenic causes
- Previous pelvic radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenSubjects 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. | Drug | Baclofen, Then Placebo, Placebo, Then Baclofen |
| PlaceboSubjects 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. | Drug | Baclofen, Then Placebo, Placebo, Then Baclofen |
Primary outcome
Urine Flow Rate, as Measured With Uroflometry
Time frame: Baseline and 4 weeks
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
Time frame: Baseline and 4 weeks
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)
Time frame: Baseline and 4 weeks
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
Time frame: Baseline and 4 weeks
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.
2 secondary outcomes
Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms.
Time frame: Baseline and 4 weeks
Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopal Badlani, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen in people with Overactive Bladder and Constipation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Flow Rate, as Measured With Uroflometry (time frame: Baseline and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018; AzTrials last refreshed its copy on 30 Oct 2026.