The effect of perineuropathy and posterior anterior repair (APR) on body image, sexual function and quality of life in postoperative women
Design
A clinical trial without a control and non-blind group in which the study and randomization phase does not apply in this study on 119 female patients with rectocele, cystocele and uterine prolapse who are candidates for perineural surgery and posterior anterior repair (APR)
Settings and conduct
The researcher refers to the mentioned hospitals. While introducing himself to the clients he talks about the study and its goals and explains the ethical considerations. The informed consent form is obtained from the subjects. Then three questionnaires of women's sexual satisfaction body image and quality of life; It is explained to the patients and in case of complete and informed consent it is delivered to them and collected after completion.
Patients undergo perineurography and anterior-posterior repair (APR). Six months after the above operation, three questionnaires are completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with rectocele, cystocele and uterine prolapse candidate for perineuropathy and posterior anterior repair (APR) surgery; consent to enter the study.
Exclusion criteria: lack of access to the subject for follow-up; do not tend to continue participation in the study
Intervention groups
Women with rectocele, cystocele and uterine prolapse, etc., who are candidates for perineuropathy and posterior anterior repair (APR) surgery; Are selected.They undergo perineurectomy and posterior anterior repair (APR).
Main outcome variables
Body image, sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027998N9
Registration date:2021-04-15, 1400/01/26
Registration timing:registered_while_recruiting
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of perineuropathy and posterior anterior repair (APR) on body image, sexual function and quality of life in postoperative women
Public title
The effect of perineuropathy and posterior anterior repair (APR) in postoperative patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with rectocele, cystocele and uterine prolapse candidate for perineural surgery and posterior anterior repair (APR)
Satisfaction to enter the research
Exclusion criteria:
Exclusion of the subject from the study
Lack of access to the subject to follow up
Age
From 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
119
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8184853541
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.MUI.MED.REC.1399.583
Health conditions studied
1
Description of health condition studied
Rectocell
ICD-10 code
N81.6
ICD-10 code description
Rectocele
2
Description of health condition studied
Cystocell
ICD-10 code
N81.1
ICD-10 code description
Cystocele
3
Description of health condition studied
uterine prolapse
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body image
Timepoint
Before surgery and six months after surgery
Method of measurement
Questionnaire MBSRQ
2
Description
Sexual function
Timepoint
Before surgery and six months after surgery
Method of measurement
Questionnaire FSFI
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before surgery and six months after surgery
Method of measurement
questionnaire sf-36
Intervention groups
1
Description
Intervention group: This study is performed among patients referred to Isfahan women's centers and hospitals. Women who have been diagnosed with rectocele, cystocele and uterine prolapse, etc., and are candidates for perineuropathy and posterior anterior repair (APR) surgery; Are selected. Due to the immorality of depriving patients of treatment, it is not possible to select a control group. Sampling is done by available census. The researcher refers to the mentioned hospitals. While introducing himself to the clients, he talks about the study and its goals and explains the ethical considerations. The informed consent form is obtained from the subjects. Then three questionnaires of women's sexual satisfaction, body image and quality of life; It is explained to the patients and in case of complete and informed consent, it is delivered to them and collected after completion. Patients undergo perineurography and posterior anterior repair (APR). Six months after the above operation, three questionnaires of women's sexual satisfaction, body image and quality of life, distribution, completion and collection are again.