Evaluation of the effect of pelvic floor muscle training using biofeedback on the symptoms of the women with pelvic organ prolapse
Design
The study only has an intervention group. sample size is 20.
Settings and conduct
Patients with pelvic organ prolapse will be referred by a gynecologist after an examination. Patients will be treated at the clinic of the Rehabilitation School of Isfahan University of Medical Sciences and by the responsible student. Treatment will be pelvic floor muscle training using biofeedback. The symptoms of prolapse and urinary incontinence will be measured before intervention and after 12 sessions of treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women aged 20-70 years; Women with stage 2 or 3 prolapse Non-inclusion criteria: Women with neurological and psychological disorders
Intervention groups
This study has a group and its intervention, is pelvic floor muscle training using biofeedback.
Main outcome variables
Stage of prolapse; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180828040898N2
Registration date:2019-04-27, 1398/02/07
Registration timing:retrospective
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Zahra Gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5724 1347
Email address
zahra.gorji70@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-04-30, 1397/02/10
Actual recruitment end date
2018-09-21, 1397/06/30
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Effect of pelvic floor muscle training using biofeedback on the symptoms and quality of life of the women with pelvic organ prolapse
Public title
The effect of biofeedback on the symptoms of the women with prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with pelvic organ prolapse
Women aged 20 to 70 years
Exclusion criteria:
Breastfeeding
previous prolapse surgery
neurological and psychologichal disorders
untreated urinary tract infection
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
87713878710
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.NUI.REC.1396.3.759
Health conditions studied
1
Description of health condition studied
Pelvic Organ Prolapse
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stage of pelvic organ prolapse
Timepoint
At the beginning of the study and 4 weeks later at the last treatment session
Method of measurement
Pelvic Organ Prolapse Quantification system
2
Description
ًQuality of life
Timepoint
At the beginning of the study and 4 weeks later at the last treatment session
Method of measurement
Prolapse Quality of Life Questionnaire
Secondary outcomes
1
Description
Symptoms of urinary incontinence
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms questionnaire
2
Description
Pelvic floor muscle strength
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Perineometer instrument
Intervention groups
1
Description
Intervention group: In this group, patients will receive pelvic floor muscle training using biofeedback. Patients will be treated with Biofeedback for 4 weeks and 3 sessions each week. Each treatment session will be 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Zahra Gorji
Street address
Soffe Ave., Azady Squar
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Email
Zahra.gorji70@ymail.com
2
Recruitment center
Name of recruitment center
Sedighe Tahere hospital
Full name of responsible person
Zahra Gorji
Street address
Khoram Ave., Jomhory Squar
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Email
Zahra.gorji70@ymail.com
3
Recruitment center
Name of recruitment center
Shahidbeheshty hospital
Full name of responsible person
Zahra Gorji
Street address
Motahhary Ave
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Email
Zahra.gorji70@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas ali Pourmomeny
Street address
Hezar jarib Ave., Azady Squar., Kuye Emam Neibourhood
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Email
Zahra.gorji@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Gorji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Hezarjarib Ave., Azadi Squar
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Fax
Email
Zahra.gorji70@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Gorji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Hezarjarib Ave., Azadi Squar
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Fax
Email
Zahra.gorji70@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Gorji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Hezarjarib Ave., Azadi Squar
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Phone
+98 31 5724 1347
Fax
Email
Zahra.gorji70@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available