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IRCT20191030045274N1 IRCT 2020-01-11 Shahid Beheshti University of Medical Sciences Effect of biofeedback, psyllium and polyethylene glycol in treating constipation due to dyssynergia Comparison of biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative for treatment of constipation in patients with pelvic floor dyssynergia 2018-02-20 anticipated 105 Complete https://irct.ir/trial/43367 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study we used simple randomized allocation with random number table. All patients had equal chance of being placed in each group.The randomization unit was individualized and the random sequence was based on a random number table.Color, odor, drug form and biofeedback exercise were similar in all groups, Blinding description: n this single blinded study, all participants completed a written informed consent in one of the study groups and in order to avoid prejudice, the subjects were attempted to be as similar in shape, color and smell as possible. N/A Constipation due to pelvic floor dyssynergia. Intervention 1: Intervention group: First group: Patients who are assigned to do biofeedback exercises and also receive 15 grams of psyllium powder twice daily for three weeks. Intervention 2: Intervention group: Second group:Patients who are assigned to do biofeedback exercises and also receive 10 grams of polethylene glycol twice daily for three weeks. Intervention 3: Control group:Patients who are assigned to do biofeedback exercises. Each patient receives one session of education which takes 1.5 hours. They will be taught relaxation of anal sphincter, better sensation of defecation and rectoanal coordination by rectal probe. Yes - There is a plan to make this available What will be shared: All potential data could be shared after the patients are unidentified. When: Accessing the information will be 6 months after publishing the data. To whom: The data will be available to all researchers working in scientific and academic institutes. Conditions: The data will only be accessible by academic researchers for use in accredited scientific centers. Where to obtain: Dr. Mohammad Sadegh Jamashidi: sadegh.jamshidi@yahoo.com mobile number: 00989123447508 How to obtain: The applicant must provide complete information about the field of work, specialty, academic record, email, address and phone number. Comments:
public Habib Malekpour
Shahid Madani St., Imam Hossein hospital
Tehran Iran (Islamic Republic of) 1985711151 +98 21 7343 3000 habib.malekpour@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Sadegh Jamshidi
No.45, Allame Shomali, 18th St., Saadatabad
Tehran Iran (Islamic Republic of) 1997988435 +98 21 2206 0674 sadegh.jamshidi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who had history or signs of constipation due to dyssynergia which were confirmed by anorectal maometery 15 years 85 years Both Patients who had constipation due to secondary causes such as using opioids, endocrine diseases, neurologic diseases, history of surgery, etc. Treatment - Drugs Treatment - Drugs Rehabilitation Intervention group: First group: Patients who are assigned to do biofeedback exercises and also receive 15 grams of psyllium powder twice daily for three weeks. Intervention group: Second group:Patients who are assigned to do biofeedback exercises and also receive 10 grams of polethylene glycol twice daily for three weeks. Control group:Patients who are assigned to do biofeedback exercises. Each patient receives one session of education which takes 1.5 hours. They will be taught relaxation of anal sphincter, better sensation of defecation and rectoanal coordination by rectal probe. Wellbeing by patient. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Medication use to evacuation. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Digitation to evacuate. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Difficulties to evacuate. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Return to toilet to evacuate. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Feeling of incomplete evacuation. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Straining to evacuate. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Time needed to evacuate. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Life style alteration. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Rectal bleeding. Timepoint: in the beginning of study and three weeks after treatment. Method of measurement: asking the patient. Shahid Beheshti University of Medical Sciences Approved 2018-05-05 Ethics committee of Shahid Beheshti university of medical sciences No. 45, West 18th Ave., Allame Shomali Blvd., Saadatabad Tehran Tehran Iran (Islamic Republic of)