Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2010

Study Completion Date

July 31, 2011

Conditions
ConstipationDyssynergia
Interventions
DEVICE

Home Biofeedback Therapy

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.

OTHER

Office 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:

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Augusta University

OTHER

NCT03202771 - Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation | Biotech Hunter | Biotech Hunter