Randomized Controlled Trial of Home Versus Office Biofeedback for Constipation
Condition: Constipation; Dyssynergia
MeSH terms: Ataxia; Constipation
Study type: Interventional

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.
    

Intervention name(s): Home Biofeedback Therapy; Office Biofeedback Therapy
Intervention type(s): Device; Other
Intervention description(s): 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.; 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:
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment