Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation

NCT03202771 | Completed DMC

• 1 other identifier: 2RO1-DK057-100-06A
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation; Dyssynergia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Colon Transit

  3 months

Study Arms (2)

Home Biofeedback Therapy

EXPERIMENTAL

Patients will use home biofeedback device to practice their maneuvers taught by the nurse.

Device: Home Biofeedback Therapy

Office Biofeedback Therapy

ACTIVE COMPARATOR

Patients will get regular office biofeedback therapy with an anal probe inserted while a nurse runs through the exercise session together.

Other: Office Biofeedback Therapy

Interventions

Home Biofeedback Therapy DEVICE

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.

Home Biofeedback Therapy

Office Biofeedback Therapy OTHER

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:

Office Biofeedback Therapy

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead
• National Institutes of Health (NIH): collaborator

Related Publications (2)

• 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.

  PMID: 31170114 DERIVED

• 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.

  PMID: 30236904 DERIVED

MeSH Terms

Conditions

Constipation; Ataxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: February 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: November 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share