Rectal Sensory Training - A Study of Two Techniques
Primary Purpose
Rectal Hyposensitivity, Constipation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Syringe Conditioning
Barostat Conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Hyposensitivity
Eligibility 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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Syringe Conditioning
Barostat Conditioning
Arm Description
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Outcomes
Primary Outcome Measures
Rectal Sensory Thresholds
Secondary Outcome Measures
Satisfaction with bowel function based on Visual Analog Scale (VAS)
Full Information
NCT ID
NCT00982839
First Posted
September 22, 2009
Last Updated
September 16, 2014
Sponsor
Augusta University
1. Study Identification
Unique Protocol Identification Number
NCT00982839
Brief Title
Rectal Sensory Training - A Study of Two Techniques
Official Title
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Data Monitoring Committee
No
5. 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:
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.
To investigate the impact of sensory conditioning on psychosocial issues and quality of life.
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:
Lower sensory thresholds for rectal perception (first sensation, desire to defecate and urgency)
Greater satisfaction with bowel function (VAS Score), stool frequency,consistency & straining.
Better learning ability and greater ease of administering this training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Hyposensitivity, Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Syringe Conditioning
Arm Type
Active Comparator
Arm Description
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Arm Title
Barostat Conditioning
Arm Type
Experimental
Arm Description
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Intervention Type
Procedure
Intervention Name(s)
Syringe Conditioning
Other Intervention Name(s)
Syringe
Intervention Description
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Intervention Type
Procedure
Intervention Name(s)
Barostat Conditioning
Other Intervention Name(s)
Barostat
Intervention Description
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
Primary Outcome Measure Information:
Title
Rectal Sensory Thresholds
Time Frame
Trial entry and at the end of 3 months
Secondary Outcome Measure Information:
Title
Satisfaction with bowel function based on Visual Analog Scale (VAS)
Time Frame
Trial Entry and at the end of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish Rao, Md, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
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Rectal Sensory Training - A Study of Two Techniques
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