NCT03202771|CompletedDMC
Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation
Home Versus Office Biofeedback Training for Dyssynergic Defecation
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Home Versus Office Biofeedback Training for Dyssynergic Defecation
Sponsor study identifier
interventional
100
0 countries
N/A
Study Start
February 2007
Actual (reported)Primary Completion
December 2010
Actual (reported)Study Completion
July 2011
Actual (reported)Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled therapist and sophisticated equipment and is not widely available. The investigators designed and tested a novel home biofeedback device and predict that home training will be as effective as office biofeedback therapy. Our specific aims are to perform a randomized controlled trial of 100 subjects with dyssynergic defecation to investigate: (A) Whether a self-administered, home-biofeedback training program with a new portable device is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia (defecation index), and ability to expel simulated stool, and ii) symptomatology- satisfaction with bowel function, number of complete spontaneous bowel movements, stool consistency, straining and quality of life. (B) Whether home-training is more cost-effective than office-based biofeedback training.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2007
Actual (reported)December 2010
Actual (reported)July 2011
Actual (reported)June 27, 2017
Actual (reported)June 29, 2017
Actual (reported)Presence of Dyssynergia
Dyssynergia pattern
3 months
Balloon Expulsion Time
Time it takes for a subject to expel a balloon that has been inserted into the rectum.
3 months
Number of Complete Spontaneous Bowel Movements
Number of how many bowel movements occur without using an aid to have a bowel movement.
3 months
Global Bowel Satisfaction
visual analog scale of symptoms
3 months
Colon Transit
3 months
Patients will use home biofeedback device to practice their maneuvers taught by the nurse.
Patients will get regular office biofeedback therapy with an anal probe inserted while a nurse runs through the exercise session together.
Patients will be taught how to use the home-trainer in a single lab session. Then we will place a reusable, dual sensor, probe into their rectum. The probe is connected to a hand- held pressure monitor displaying the patient's response. Next, the clothed patient will be asked to sit on a commode, and attempt 15 bearing down maneuvers. When the anal sphincter pressure decreases more lights go on. If the patient cannot relax then fewer lights go on. Thus, the number of lighted lights gives instant feedback about their performance. Patients will get a 20-minute tape recording for home use. Patients will be asked to insert the probe at least twice daily and each time practice at least 15 bearing down maneuvers; a daily log will be kept. At 4 and 8 weeks, they will return for follow up. Based on their progress, new targets will be set by adjusting the device's sensitivity.
Rao SSC, Go JT, Valestin J, Schneider J. Home Biofeedback for the Treatment of Dyssynergic Defecation: Does It Improve Quality of Life and Is It Cost-Effective? Am J Gastroenterol. 2019 Jun;114(6):938-944. doi: 10.14309/ajg.0000000000000278.
Rao SSC, Valestin JA, Xiang X, Hamdy S, Bradley CS, Zimmerman MB. Home-based versus office-based biofeedback therapy for constipation with dyssynergic defecation: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2018 Nov;3(11):768-777. doi: 10.1016/S2468-1253(18)30266-8. Epub 2018 Sep 18.
100 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2017
First Posted
June 29, 2017
Study Start
February 2007
Actual (reported)Mechanism of Action of Biofeedback Therapy
A monitor screen will provide visual feedback by showing changes in pressure activity. First patients will be taught abdominal muscle coordination exercise to improve the pushing effort during defecation. Here, patients are taught how to distend the abdomen by inhaling slowly and then holding their breath for at least 15 seconds and to practice this for 20 minutes, twice a day. Thereafter, patients will be asked to attend the motility laboratory, biweekly for up to 6 training sessions. Biofeedback Therapy (BT) will be performed by a 3-sensor manometry probe. The clothed patient will be seated on a commode in front of a monitor. The physician/nurse therapist will give verbal feedback by either complimenting the patient for performing a correct maneuver or rectifying any errors. Each 60 minute treatment session will comprise of the following maneuvers:
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Primary Completion
December 2010
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
November 9, 2017
Record last verified: 2017-06
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