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Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation

Primary Purpose

Constipation, Dyssynergia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Biofeedback Therapy
Office Biofeedback Therapy
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • During the previous year, all patients must have experienced or reported at least two of the following symptoms for at least three months and with 25% of bowel movements (when not taking laxatives):
  • stool frequency of less than three/week,
  • passage of hard stools,
  • excessive straining,
  • a feeling of incomplete evacuation,
  • sensation of anorectal obstruction or blockage and
  • use of manual maneuvers to facilitate defecations (e.g., digital evacuation).
  • No evidence of structural disease (excluded by colonoscopy/ b. enema and metabolic problem by lab tests.
  • Patients on stable doses of antidepressants without anticholinergic effects will be included.

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.
  • Ulcerative/Crohns colitis.
  • Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
  • Rectal prolapse or anal fissure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Home Biofeedback Therapy

    Office Biofeedback Therapy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Presence of Dyssynergia
    Dyssynergia pattern
    Balloon Expulsion Time
    Time it takes for a subject to expel a balloon that has been inserted into the rectum.
    Number of Complete Spontaneous Bowel Movements
    Number of how many bowel movements occur without using an aid to have a bowel movement.
    Global Bowel Satisfaction
    visual analog scale of symptoms

    Secondary Outcome Measures

    Colon Transit
    colon transit time

    Full Information

    First Posted
    June 27, 2017
    Last Updated
    November 7, 2017
    Sponsor
    Augusta University
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03202771
    Brief Title
    Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation
    Official Title
    Home Versus Office Biofeedback Training for Dyssynergic Defecation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (Actual)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Augusta University
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Study Protocol: Patients will be randomized to receive either office-based biofeedback therapy or home-based biofeedback training, in addition to the standard treatment described below. Randomization procedures: The permuted blocks method will randomize patients for all study aims; this ensures approximate balance among the two treatment arms, while making it unlikely that investigators will predict the next treatment assignment. The study statistician will prepare sequentially numbered sealed envelopes containing the treatment assignment. Thus the next treatment assignment cannot be read without opening the envelope. If a patient is deemed eligible, and agrees to participate, after signing the informed consent, the investigator will open the next envelope to determine the treatment assigned to that patient. Standard Treatment: The patient will be seen by one of the gastroenterologists and receive instructions regarding their problem and advice on exercises, timed toilet training, laxatives, diet and fluid intake. Written materials will be given to each patient and the study coordinator will reinforce the information. Timed-toilet training: This consists of educating the patient regarding the anatomy and physiology of the pelvic floor and diaphragmatic breathing technique. They will be advised to attempt a bowel movement twice a day, 30 minutes after meals and strain for five minutes and push at a level of 5-7/10. Laxatives: Patients will be asked to use 500 mg magnesium gluconate, 2-3 tablets/day or Milk of Magnesia 1-3 tablespoons daily. If intolerant, they will be advised to use bisacodyl (1-2 daily) or sennokot (1-2 daily), but to titrate the dose. Patients will be asked to refrain from using digital maneuvers and enemas. Rescue medications will include bisacodyl suppositories (no BM for 48 hrs) or enema (no BM for 72 hours). If bowel movement is regular i.e. soft stool >3/week, they will be asked to reduce the laxative dose by 1/3rd. Diet: Based on a three-day prospective food diary, patients will get advice by the GCRC dietician. The recommendations will include the advice to eat 5 servings of fruits and vegetables per day, and 25 g dietary fiber from natural foods, and consume ~30% of calories from fat. Three-day food records, obtained at baseline, and at 4, 8 and 12 weeks, will assess dietary compliance. Subjects will get a diet report to reinforce adherence. Office Biofeedback (Neuromuscular conditioning) Treatment- The aim of biofeedback will be to establish a normal pattern of defecation and improve rectal sensation using visual/verbal biofeedback technique. 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. 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: Recto-Anal Coordination This maneuver's goal is to produce a coordinated movement that simultaneously increases the intra abdominal (intra rectal) pressure and relaxes the anal sphincter. First, the patient is educated about their abnormal tracing: A normal pattern is shown and they are encouraged to reproduce this. The patients' posture and breathing are continuously monitored and corrected and verbal reinforcement provided. If a patient consistently demonstrates normal rectoanal coordination, then they are asked to reproduce this without feedback. Approximately 15 bearing down maneuvers are performed at 1 minute intervals, some with and some without rectal balloon distention. Simulated defecation: This is performed by placing a fecom (artificial stool) into the rectum. The patient is asked to sit on a commode and expel the fecom. Their movements, posture, and breathing techniques are corrected and feedback is provided. The therapist may assist the patient's effort by applying gentle traction to the fecom, while reinforcing their straining technique. The maneuver is repeated twice. Assessment of Improvement: The number of training sessions will be customized for each patient (maximum 6). Training will be discontinued if a patient demonstrates during two consecutive training sessions, without feedback a) normal pattern of defecation in at least 50% of attempts, and b) at least 20% improvement in bowel satisfaction (VAS) (64). If these goals are not achieved, patients will be considered treatment failures. Home Biofeedback Treatment: After getting advice on standard treatment and breathing exercises, patients will be taught how to use the home-trainer in a single lab session. Then the investigators 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 (Anatoner, Protech, Hyderabad, India). 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. After 3-months, they will have a colonic transit, anorectal manometry and fecom expulsion study. Progress will be monitored through bi-weekly phone calls.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation, Dyssynergia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Home Biofeedback Therapy
    Arm Type
    Experimental
    Arm Description
    Patients will use home biofeedback device to practice their maneuvers taught by the nurse.
    Arm Title
    Office Biofeedback Therapy
    Arm Type
    Active Comparator
    Arm Description
    Patients will get regular office biofeedback therapy with an anal probe inserted while a nurse runs through the exercise session together.
    Intervention Type
    Device
    Intervention Name(s)
    Home Biofeedback Therapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Office Biofeedback Therapy
    Intervention Description
    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:
    Primary Outcome Measure Information:
    Title
    Presence of Dyssynergia
    Description
    Dyssynergia pattern
    Time Frame
    3 months
    Title
    Balloon Expulsion Time
    Description
    Time it takes for a subject to expel a balloon that has been inserted into the rectum.
    Time Frame
    3 months
    Title
    Number of Complete Spontaneous Bowel Movements
    Description
    Number of how many bowel movements occur without using an aid to have a bowel movement.
    Time Frame
    3 months
    Title
    Global Bowel Satisfaction
    Description
    visual analog scale of symptoms
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Colon Transit
    Description
    colon transit time
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: During the previous year, all patients must have experienced or reported at least two of the following symptoms for at least three months and with 25% of bowel movements (when not taking laxatives): stool frequency of less than three/week, passage of hard stools, excessive straining, a feeling of incomplete evacuation, sensation of anorectal obstruction or blockage and use of manual maneuvers to facilitate defecations (e.g., digital evacuation). No evidence of structural disease (excluded by colonoscopy/ b. enema and metabolic problem by lab tests. Patients on stable doses of antidepressants without anticholinergic effects will be included. 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. Ulcerative/Crohns colitis. Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery. Rectal prolapse or anal fissure.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31170114
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    30236904
    Citation
    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.
    Results Reference
    derived

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    Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation

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