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Evaluating the effect of biofeedback combined with diet in treatment of patients with constipation due to paradoxical contraction of the pelvic floor muscles

Protocol summary

Summary
Objectives: The purpose of the study is to assess the efficacy of biofeedback and regimen in the treatment of patients with constipation due to paradoxical pelvic floor movement. Design: This is an interventional study. Setting and conduct: Data include physical examinations, the results of manometry as well as tracking the status of clinical symptoms before and after treatment by CCF questionnaire. Inclusion criteria: Include diagnosis of constipation due to pelvic floor muscle disorders and digital rectal examination. Exclusion criteria: Inflammatory bowel disease,HIV infection, neurological disorders, urinary-stress incontinence, Urgency incontinence, Fecal incontinence. Interventions: group 1: Biofeedback + diet includes vegetables, drinking 6 to 8 glasses of water per day, psyllium powder 1 to 2 sachet per day , and walking three days a week, for half an hour every day group 2: Diet includes vegetables, drinking 6 to 8 glasses of water per day, psyllium powder 1 to 2 sachet per day , and walking three days a week, for half an hour every day. Main outcome measures: Constipation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102930545N1
Registration date: 2017-04-29, 1396/02/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-29, 1396/02/09
Registrant information
Name
Tahereh Forooghifar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2365
Email address
tforooghifar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of biofeedback combined with diet in treatment of patients with constipation due to paradoxical contraction of the pelvic floor muscles
Public title
The effect of biofeedback combined with diet in treatment of patients with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Terms of Inclusion: diagnosis of constipation due to pelvic floor muscle disorders, digital rectal examination. Exclusion conditions: inflammatory bowel disease; HIV infection; neurological disorders, stress urinary incontinence, Urge Incontinence, fecal incontinence.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Keashavrz Blvd, Tehran
City
Tehran
Postal code
Approval date
2016-10-15, 1395/07/24
Ethics committee reference number
IR.TUMS.VCR.REC.1395.778

Health conditions studied

1

Description of health condition studied
constipation due to paradoxical contraction of the pelvic floor muscles
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
constipation
Timepoint
before the intervention, 3 months after beginning of the intervention, 6 months after beginning of the intervention, 1 year after beginning of the intervention
Method of measurement
Physical examination, the results of manometry as well as track the status of clinical symptoms before and after treatment by CCF questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Biofeedback + diet includes vegetables, drinking 6 to 8 glasses of water per day, psyllium powder 1 to 2 sachet per day , and walking three days a week, for half an hour every day
Category
Lifestyle

2

Description
diet includes vegetables, drinking 6 to 8 glasses of water per day, psyllium powder 1 to 2 sachet per day , and walking three days a week, for half an hour every day
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Tahereh Forooghifar
Street address
Ayatollah Taleghani Hospital, Yaman Street,A'raabi street,Chamran Highway, Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Tahereh Forooghifar
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz Blvd. and Qods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Tahereh Forooghifar
Position
Gynecologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2365
Fax
Email
forooghifar.f@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Tahereh Forooghifar
Position
Gynecologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2365
Fax
Email
forooghifar.f@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Tahereh Forooghifar
Position
Gynecologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
forooghifar.f@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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