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NCT01003249 · ClinicalTrials.gov registry record · Phase 4
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
A Phase 4 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01003249 is a Phase 4 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants.
The verdict
NCT01003249, a Phase 4 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01003249
The ClinicalTrials.gov registry entry for NCT01003249 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01003249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01003249 about?
NCT01003249 is a clinical study titled "Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen". 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 existen...
What is the current status of trial NCT01003249?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2009-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01003249?
The interventions under investigation include: Placebo (DRUG), Baclofen (DRUG).
Who is sponsoring clinical trial NCT01003249?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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