Status:
COMPLETED
Rectal Sensory Training - A Study of Two Techniques
Lead Sponsor:
Augusta University
Conditions:
Rectal Hyposensitivity
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00982839
Start Date
March 1 2004
End Date
July 1 2014
Last Update
September 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242