Rectal Sensory Training - A Study of Two Techniques
Public ClinicalTrials.gov record NCT00982839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00982839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2004
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Sep 16, 2014
2004 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00982839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2014 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00982839 live on ClinicalTrials.gov.