Comparison of biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative for treatment of constipation in patients with pelvic floor dyssynergia
Evaluating the effect of biofeedback in combination with laxatives in patients with constipation due to pelvic floor dyssynergia.
Design
In this single-blinded clinical trial, 88 patients with dyssynergic constipation were randomly divided into 3 groups. After obtaining and confirming their consent, the treatment with "exclusively biofeedback" , or "Biofeedback + psyllium" or biofeedback + polyethylene glycol "were administered for 2 to 3 weeks. All treatments for patients in all three groups were eligible and no intervention beyond treatment protocols. Also, all the research costs came from research project resources, and no additional costs for the clinical evaluations and expert visits were charged.
Settings and conduct
This study was performed on patients with dyssynergic constipation who referred to gastrointestinal ward of Taleghani hospital during the years 2018 to 2019.
Participants/Inclusion and exclusion criteria
Patients who had history or signs of constipation due to dyssynergia confirmed by anorectal manometery, were included.
Patients who had constipation due to secondary causes such as using opioids, endocrine diseases, neurologic diseases, history of surgery, etc, were excluded.
Intervention groups
1.The first group were treated with the routine biofeedback method
2. The second group were treated with biofeedback plus fiber laxative (psyllium)
3. The third group were treated with biofeedback plus osmotic laxative (polyethylene glycol)
Main outcome variables
Medication use for evacuation; difficulty to evacuate; digitation to evacuate; return to toilet to evacuate; feeling of incomplete evacuation; straining to evacuate; time needed for evacuation; life style change; rectal bleeding; well being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045274N1
Registration date:2020-01-11, 1398/10/21
Registration timing:retrospective
Last update:2020-01-11, 1398/10/21
Update count:0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
Mohammad Sadegh Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 0674
Email address
sadegh.jamshidi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Comparison of biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative for treatment of constipation in patients with pelvic floor dyssynergia
Public title
Effect of biofeedback, psyllium and polyethylene glycol in treating constipation due to dyssynergia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had history or signs of constipation due to dyssynergia which were confirmed by anorectal maometery
Exclusion criteria:
Patients who had constipation due to secondary causes such as using opioids, endocrine diseases, neurologic diseases, history of surgery, etc.
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
105
Actual sample size reached:
88
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
No. 45, West 18th Ave., Allame Shomali Blvd., Saadatabad
City
Tehran
Province
Tehran
Postal code
1997988435
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.SBMU.MSP.REC.1398.063
Health conditions studied
1
Description of health condition studied
Constipation due to pelvic floor dyssynergia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wellbeing by patient
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
2
Description
medication use to evacuation
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
3
Description
Digitation to evacuate
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
4
Description
difficulties to evacuate
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
5
Description
return to toilet to evacuate
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
6
Description
feeling of incomplete evacuation
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
7
Description
straining to evacuate
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
8
Description
time needed to evacuate
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
9
Description
life style alteration
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
10
Description
rectal bleeding
Timepoint
in the beginning of study and three weeks after treatment
Method of measurement
asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Research institute for gastroenterology and liver disease, Taleghani hospital
Full name of responsible person
Hamaid asadzadeh
Street address
Evin, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2539
Email
sadegh.jamshidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Abdi
Street address
Evin, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2539
Email
sadegh.jamshidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Habib Malekpour
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
gastroenterology
Street address
Shahid Madani St., Imam Hossein hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 7343 3000
Email
habib.malekpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Jamshidi
Position
Medical specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.45, Allame Shomali, 18th St., Saadatabad
City
Tehran
Province
Tehran
Postal code
1997988435
Phone
+98 21 2206 0674
Email
sadegh.jamshidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Jamshidi
Position
Medical specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.45, Allame Shomali, West 18th St., Saadatabad
City
Tehran
Province
Tehran
Postal code
1997988435
Phone
+98 21 2206 0674
Email
sadegh.jamshidi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data could be shared after the patients are unidentified.
When the data will become available and for how long
Accessing the information will be 6 months after publishing the data.
To whom data/document is available
The data will be available to all researchers working in scientific and academic institutes.
Under which criteria data/document could be used
The data will only be accessible by academic researchers for use in accredited scientific centers.
From where data/document is obtainable
Dr. Mohammad Sadegh Jamashidi: sadegh.jamshidi@yahoo.com
mobile number: 00989123447508
What processes are involved for a request to access data/document
The applicant must provide complete information about the field of work, specialty, academic record, email, address and phone number.