We aimed to study the effect of colporraphy surgery on the urinary and sexual problems in women with pelvic prolapse. Study population: 70 women with pelvic prolapse referred to Besat hospital in Sanandaj, Iran. Inclusion criteria: married and having child, aged between 20-49 years. Exclusion criteria: divorced, history of pelvic surgery and breast disease, drug abused, chronic disease, sexual problems in husband, urinary tract and genital infections. Intervention: anterior and posterior colporraphy. Primary outcome: urinary and sexual problems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809082788N1
Registration date:2009-09-21, 1388/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-21, 1388/06/30
Registrant information
Name
Shole Shahgheibi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 5910
Email address
shole.shahgheibi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2009-09-21, 1388/06/30
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of colporrhaphy surgery on the urinary and sexual problems in women with pelvic prolapse
Public title
Effect of colporraphy surgery on the urinary and sexual problems in women with pelvic prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: married and having child, aged between 20-49 years. Exclusion criteria: divorced, history of pelvic surgery and breast disease, drug abused, chronic disease, sexual problems in husband, urinary tract and genital infections.
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Kurdistan University of Medical Sciences
Street address
Pasdaran street
City
Sanandaj
Postal code
Approval date
2009-03-18, 1387/12/28
Ethics committee reference number
12093
Health conditions studied
1
Description of health condition studied
sexual and urinary problem in pelvic organ prolaps
ICD-10 code
N81.6
ICD-10 code description
Rectocele
2
Description of health condition studied
sexual and urinary problem in pelvic organ prolaps
ICD-10 code
N81.1
ICD-10 code description
Cystocele
3
Description of health condition studied
sexual and urinary problem in pelvic organ prolaps
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
4
Description of health condition studied
sexual and urinary problem in pelvic organ prolaps
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
sexual and urinary problem
Timepoint
one day before surgery and 1-90-180 days after surgery
Method of measurement
physical exame and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
anterior and posterior colporraphy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Street address
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kurdistan University of Medical Sciences
Full name of responsible person
Dr A Heidary
Street address
Medical faculty, Pasdaran St.
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Sana Faizi
Position
Medical intern
Other areas of specialty/work
Street address
Besat hospital
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
+98 87 1323 4600
Email
www.f.sana@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Shole Shahgheibi
Position
Specilist in obstetric and gynecology
Other areas of specialty/work
Street address
Besat hospital
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
+98 87 1225 3744
Email
shole.shahgheibi@muk.ac.ir , shahgheibi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sana Faizi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)