Clincosm LogoSign in Get a demo

Rectal Sensory Training - A Study of Two Techniques

Sponsor
Augusta University (Other)
Overall Status
Completed
CT.gov ID
NCT00982839
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
124
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Syringe Conditioning
  • Procedure: Barostat Conditioning
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Barostat

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rectal Sensory Thresholds [Trial entry and at the end of 3 months]

    Secondary Outcome Measures

    1. Satisfaction with bowel function based on Visual Analog Scale (VAS) [Trial Entry and at the end of 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Augusta University

    Investigators

    • Principal Investigator: Satish Rao, Md, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Satish Rao, Professor, Augusta University
    ClinicalTrials.gov Identifier:
    NCT00982839
    Other Study ID Numbers:
    • 5R01DK057100-08
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Sep 17, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Constipation

    Study Results

    No Results Posted as of Sep 17, 2014