Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00982839 · ClinicalTrials.gov registry record · Phase 2
Rectal Sensory Training - A Study of Two Techniques
A Phase 2 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT00982839 is a Phase 2 study that has completed, run by Augusta University. The registered enrollment target is 70 participants.
The verdict
NCT00982839, a Phase 2 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
At least 60% of patients with constipation and dyssynergic defecation (anismus) and between 30-50% of patients with fecal incontinence exhibit impaired rectal sensation. The problem may be improved by biofeedback therapy. Traditionally, biofeedback therapy was performed by using a syringe-assisted technique. Although some respond to this method, many, particularly those with severe rectal hyposensitivity have proved to be refractory. Also, repeated inflation and deflation of a large volume of air, using a hand-held syringe is cumbersome and time consuming. Recently, in pilot observations, the investigators have seen that a barostat-assisted technique of biofeedback therapy was simpler and easier to perform and could possibly be more effective. The investigators' aims are: 1. To perform a randomized controlled study that compares the syringe-assisted sensory conditioning (biofeedback therapy) technique with the barostat assisted sensory conditioning for improving the rectal sensation in patients with rectal hyposensitivity and bowel dysfunction. 2. To investigate the impact of sensory conditioning on psychosocial issues and quality of life. 3. To compare the cost-effectiveness of each therapeutic modality The specific hypotheses that will be tested are; When compared to those who receive syringe-assisted training, patients receiving barostat training will demonstrate: 1. Lower sensory thresholds for rectal perception (first sensation, desire to defecate and urgency) 2. Greater satisfaction with bowel function (VAS Score), stool frequency,consistency \& straining. 3. Better learning ability and greater ease of administering this training.
Interventions
- PROCEDURE Syringe Conditioning
- PROCEDURE Barostat Conditioning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2004-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00982839
The ClinicalTrials.gov registry entry for NCT00982839 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Syringe Conditioning is the first listed.
NCT00982839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00982839 about?
NCT00982839 is a clinical study titled "Rectal Sensory Training - A Study of Two Techniques". At least 60% of patients with constipation and dyssynergic defecation (anismus) and between 30-50% of patients with fecal incontinence exhibit impaired rectal sensation. The problem may be improved by biofeedback therapy. Traditionally, biofeedback therapy was performed by using a syringe-assisted t...
What is the current status of trial NCT00982839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2004-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00982839?
The interventions under investigation include: Syringe Conditioning (PROCEDURE), Barostat Conditioning (PROCEDURE).
Who is sponsoring clinical trial NCT00982839?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.