The aim of this study is to search for the effect of biofeedback therapy in operated patients with rectal cancer due to fecal incontinency. Some posters posted in surgery unit to announce these patients for attending in this study, in physiatry ward. People eligible for the study will be randomized into two groups. The total number of patients are 30, with 15 in each group. In the first group, exercises of pelvic floor muscles will be trained for 6 weeks with recommendations to improve the lifestyle, and in the second group all of these instructions will be concomitant with biofeedback therapy. 6 weeks after the end of biofeedback and exercise therapy, patients will be re-evaluated. The final results of the evaluation, is assessment of Wexner scoring system and SF36 and parameters of pelvic floor contraction. Comparison of the patients who have participated in biofeedback therapy, with those in exercise therapy group, makes it possible to evaluate the efficacy of biofeedback therapy in reducing the recurrence of the disease and increasing the quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053024621N7
Registration date:2017-07-26, 1396/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
Tannaz Ahadi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 8207
Email address
ahadi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-11-25, 1395/09/05
Expected recruitment end date
2017-07-25, 1396/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of biofeedback in fecal incontinency treatment for patients with rectal cancer after inter-sphincteric resection
Public title
The effect of biofeedback in fecal incontinency treatment for patients with rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: females older than 18 years old; patients with rectal cancer that had been under the inter-sphincteric resection operation; at least 4 weeks after surgery.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat High way
City
Tehran
Postal code
Approval date
2017-02-14, 1395/11/26
Ethics committee reference number
IR.IUMS.REC.1395.9411524005
Health conditions studied
1
Description of health condition studied
Faecal incontinence
ICD-10 code
R15
ICD-10 code description
Faecal incontinence
Primary outcomes
1
Description
Pelvic floor muscle contraction
Timepoint
After surgery, 1.5 month later, 3 month later
Method of measurement
Pelvic floor muscle contraction(hpa)
Secondary outcomes
1
Description
Score obtaining from Wexner scoring system and SF36
Timepoint
After surgery, 1.5 month later, 3 month later
Method of measurement
Wexner scoring system and SF36
Intervention groups
1
Description
In the first group exercises are training in pelvic floor muscles for 6 weeks with recommendations to improve the lifestyle. patients will be re- evaluated 6 and 12 weeks later.
Category
Treatment - Other
2
Description
In the second group biofeedback therapy will be done during 6 weeks. 6 weeks after the end of biofeedback therapy and exercise performances, patients will be re- evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Golnaz Raeisi
Street address
Froozgar Hospital, Behafarin St., Hafez Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Pejman Madani
Street address
Hemmat high way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist
Other areas of specialty/work
Street address
Froozgar Hospital, Behafarin St., Hafez Ave.
City
Tehran
Postal code
Phone
+98 21 8871 8207
Fax
Email
tannaz.ahadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist
Other areas of specialty/work
Street address
Froozgar Hospital, Behafarin St., Hafez Ave.
City
Tehran
Postal code
Phone
+98 21 8871 8207
Fax
Email
tannaz.ahadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Mesical Sciences
Full name of responsible person
Golnaz Raeisi
Position
Physiatry Resident
Other areas of specialty/work
Street address
Froozgar Hospital, Behafarin St., Hafez Ave.
City
Tehran
Postal code
Phone
+98 21 8871 8207
Fax
Email
raeisi643@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)