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
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.
Outcome Measure(s)
1. Efficacy of baclofen vs. placebo on dysfunctional voiding as measured with uroflometry
and EMG; patients' symptoms score questionnaires and diaries.
2. 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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
| Recruiting |
NCT06292949 -
Clinical Study of Resistant Starch in Improving Constipation
|
N/A | |
| Recruiting |
NCT04132661 -
MRI Assessment of Mode of Action of Bisacodyl, Single Dose
|
Phase 4 | |
| Terminated |
NCT02839889 -
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)
|
Phase 4 | |
| Completed |
NCT02726295 -
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
|
Phase 4 | |
| Recruiting |
NCT02255747 -
Anal Dilatation for Infants and Children With Constipation
|
N/A | |
| Completed |
NCT02246647 -
Biomarkers for Intestinal Permeability in Patients With Constipation
|
||
| Completed |
NCT01566409 -
Maintenance Treatment for Children With Constipation
|
N/A | |
| Completed |
NCT02863848 -
Effect of Inulin-type Fructans on Constipated Children.
|
N/A | |
| Completed |
NCT02658201 -
Ultrafast MRI Imaging to Exclude Constipation
|
N/A | |
| Completed |
NCT01695915 -
Diurnal Variation in Rectal Diameter
|
N/A | |
| Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
| Completed |
NCT01411501 -
Efficacy and Safety of Acupuncture for Functional Constipation
|
Phase 3 | |
| Completed |
NCT01474499 -
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
|
Phase 3 | |
| Completed |
NCT01438567 -
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
Phase 3 | |
| Completed |
NCT01170039 -
The Effectiveness of Lubiprostone in Constipated Diabetics
|
Phase 4 | |
| Completed |
NCT00931853 -
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
|
Phase 3 | |
| Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
| Completed |
NCT00994851 -
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
|
Phase 3 | |
| Completed |
NCT01607060 -
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
|
Phase 3 |