Rectal Sensory Training - A Study of Two Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00982839
First received: September 22, 2009
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention Phase
Rectal Hyposensitivity
Constipation
Procedure: Syringe Conditioning
Procedure: Barostat Conditioning
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rectal Sensory Training - A Randomized Controlled Study of Two Techniques

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Rectal Sensory Thresholds [ Time Frame: Trial entry and at the end of 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with bowel function based on Visual Analog Scale (VAS) [ Time Frame: Trial Entry and at the end of 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2004
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Syringe Conditioning
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Procedure: Syringe Conditioning
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Other Name: Syringe
Experimental: Barostat Conditioning
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Procedure: Barostat Conditioning
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Other Name: Barostat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients categorized as having dyssynergic defecation or slow transit constipation or normal transit constipation will be eligible.
  • All patients must demonstrate rectal hyposensitivity during a manometry with values that are outside 2 S.D. of normal range and demonstrate any two of the following: a) Threshold for 1st sensation > 40 cc. b) Threshold for desire to defecate > 130 cc. c) Threshold for urgency to defecate >180 cc.

Exclusion Criteria:

  • Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued).
  • Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
  • Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
  • Impaired cognizance (mini mental score of < 15) and/or legally blind.
  • Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
  • Hirschsprung's disease.
  • Alternating constipation and diarrhea (22).
  • Ulcerative/Crohns colitis.
  • Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
  • Rectal prolapse or anal fissure. 11) Patients with severe rectal hyposensitivity, first sensation or desire to defecate > 320 cc
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00982839

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Satish Rao, Md, PhD University of Iowa
  More Information

No publications provided

Responsible Party: Satish Rao, Professor, Georgia Regents University
ClinicalTrials.gov Identifier: NCT00982839     History of Changes
Other Study ID Numbers: 5R01DK057100-08
Study First Received: September 22, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014