Comparative evaluation the effect of the pelvic floor muscle training and a novel approach of postural or positional inversion on the symptoms of the women with prolapse
Comparison of two methods of pelvic floor muscle training and a new postural method in the women with prolapse
Design
Two arm parallel group, randomized trial with blinded participant , responsible for collecting data and assessor. sample size is 40 people .
Settings and conduct
Women with prolapse regardless of symptoms will be enrolled by gynecologists. Patients will be treated at the clinic of the Rehabilitation School of Isfahan University of Medical Sciences and by the respective student. this study blinded with the participant, researcher, the person responsible for collecting.
Participants/Inclusion and exclusion criteria
People in study are the women with prolapse stage 2 or 3; and those with stages 1,0 and 4 are not included in this study.
Intervention groups
Control group intervention is pelvic floor muscle training with biofeedback. treatment of intervention group in addition to biofeedback is postural exercise .
Main outcome variables
Improvement the stage of prolapse in the Pelvic Organ Prolapse Quantification system
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180828040898N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
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
2018-01-25, 1396/11/05
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation the effect of the pelvic floor muscle training and a novel approach of postural or positional inversion on the symptoms of the women with prolapse
Public title
Evaluation the effect of exercise on prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with stage 2 or 3 prolapse
Women aged 20 to 70 years old
Exclusion criteria:
Prolapse stage 0 ,1 ,4
Previous POP surgery
Radiating back pain
Pelvic cancer
Psychiatric disorder
Untreated urinary tract infection
Planning to become pregnant during the next 6 months
Inability to contract the pelvic floor muscle
Breastfeeding
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participant, responsible for data collection, Data Safety and Monitoring Committee are blind; Researcher and clinical care are not blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Hezar jarib Ave., Azadi Squar., Kuye Emam Neibourhood
City
Isfahan
Province
Isfehan
Postal code
87713-46173
Approval date
2018-01-20, 1396/10/30
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
N81.0
ICD-10 code description
Urethrocele
Primary outcomes
1
Description
Stage of pelvic organ prolapse in the Pelvic Organ Prolapse Quantification system
Timepoint
At the beginning of the study and 4 weeks later at the last treatment session
Method of measurement
Pelvic Organ Prolapse Quantification system
Secondary outcomes
1
Description
Urinary incontinence score based on ICIQ-FLUTS questionnaire
Timepoint
At the beginning of the intervention and 4 weeks later in the last treatment session .
Method of measurement
ICIQ-FLUTS questionnaire
Intervention groups
1
Description
Control group: Pelvic floor muscle training with biofeedback
Category
Rehabilitation
2
Description
Intervention group: Biofeedback plus postural exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Isfahan University of Medical Sciences
Full name of responsible person
Zahra Gorji
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.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?