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NCT00127257 · ClinicalTrials.gov registry record · NA

Biofeedback for Dyssynergic Constipation

A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
NA
Development phase
117
Enrollment target

NCT00127257 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 117 participants.

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The verdict

NCT00127257, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
NA
Development phase
117 participants
Enrollment target

Study Summary

Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking. The aims of this study are: * to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; * to identify which patients are most likely to benefit; and * to assess the impact of treatment on quality of life.

Interventions

  • BEHAVIORAL Biofeedback
  • DRUG Diazepam
  • BEHAVIORAL Pelvic floor retraining

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 1999-09
Est. Completion 2006-06
Phase NA

What the Registry Record Tells You About NCT00127257

The ClinicalTrials.gov registry entry for NCT00127257 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Biofeedback is the first listed.

NCT00127257 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00127257 about?

NCT00127257 is a clinical study titled "Biofeedback for Dyssynergic Constipation". Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation becaus...

What is the current status of trial NCT00127257?

This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 1999-09. Estimated completion is 2006-06.

What interventions are being tested in trial NCT00127257?

The interventions under investigation include: Biofeedback (BEHAVIORAL), Diazepam (DRUG), Pelvic floor retraining (BEHAVIORAL).

Who is sponsoring clinical trial NCT00127257?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.