Comparison of sexual function before and after using a pessary in women with pelvic floor disorders.
Design
This study will be performed on all women referred to the Al-Zahra Educational Center with the diagnosis of pelvic floor disorder. This study will be Befor-After.It will be conducted as a clinical trial within 2 years.Sampling will be done with easily method.(According to estimates from previous years, the maximum will be 30).This study is not blind.
Settings and conduct
Sixty patients who referred to Al-Zahra and Taleghani hospital with pelvic organ prolapse will be selected for study.
Participants/Inclusion and exclusion criteria
Patients over the age of 18 and married will be included in the study and will not be included in the study if there is a problem with early ejaculation of the spouse and the age under 18 years
Intervention groups
All patients who referred to Alzahra's Alzahra Medical Education Center for two years of study with pelvic floor disorders and have an indication of the use of a pessary
Main outcome variables
Sexual function; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101222005448N4
Registration date:2019-01-21, 1397/11/01
Registration timing:registered_while_recruiting
Last update:2019-01-21, 1397/11/01
Update count:0
Registration date
2019-01-21, 1397/11/01
Registrant information
Name
Fateme Mallah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133336360
Email address
mallahf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sexual Function Before and After Using a Pessary in Women with Pelvic Floor Disorders
Public title
Comparison of Sexual Function Before and After Using a Pessary in Women with Pelvic Floor Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
The ability to have sex
Married
Age 18 and above
Pelvic floor disorders that do not have surgical indication
Exclusion criteria:
Having a history of chronic diseases (diabetes - high blood pressure - heart disease) affecting sexual function (in each of the couples)
Sexual problems in the spouse such as premature ejaculation and impotence
Drinking alcohol (in each of the couples)
Age
From 18 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.TBZMED.REC.1397.835
Health conditions studied
1
Description of health condition studied
Prolapse Of Pelvic Organs
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention; فwo weeks after the intervention; three months afte rintervention
Method of measurement
International Prolaps-Urrinary Incontinenc Sexual Function(PISQ-12)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention; فwo weeks after the intervention; three months afte rintervention
Method of measurement
International Prolapse-Urinary Incontinence Sexual Function(PISQ-12)
Intervention groups
1
Description
Intervention group: Put a pessary into the vagina, Made in America, mylex brand, Approved by America FDA
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fateme Mallah
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fateme Mallah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fateme Mallah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fateme Mallah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available