Determining the effect of vaginal pessary placement on quality of life, sexual self-efficacy and in women with uterine prolapse
Design
The present study is a quasi-experimental study of pre-test-post-test type. 72 individuals will be selected to participate in the study using available sampling and will be randomly assigned to the intervention and control groups. The number of sample volumes in each group is 30 people and 36 people in each group, taking into account the 10% drop. There is no blinding. After collecting data, questionnaires will be extracted and in SPSS software.
Settings and conduct
Research community of women aged 45-60 years with uterine prolapse in Tehran. Research environment of Arash Hospital and Taleghani Hospital and private offices of physicians. The questionnaire is given once before the intervention and once 8 weeks later. no action is taken for the control group.
Participants/Inclusion and exclusion criteria
-Inclusion criteria :
Women aged 45-60 years، Married women living together with their husbands، Literacy، Willingness and interest in participating in the study، Minimum grade 1 prolapse، Tendency to use pessary instead of surgery، Having pessary placement conditions، Lack of vaginitis
-Exclusion criteria:
People who refuse to cooperate in filling out the questionnaire and continuing the study، Increased vaginal discharge and infection and the patient's unwillingness to continue using the pessary.
Intervention groups
The intervention group is those who have prolapse or do not want surgery or have contraindications for surgery due to the underlying disease and their choice is a pessary. The control group is those who have uterine prolapse and do not want to have a pessary implant.
Main outcome variables
Improving quality of life and sexual efficiency; pessary clinical care management;Promoting sexual satisfaction in women with prolapse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110425006284N17
Registration date:2022-07-27, 1401/05/05
Registration timing:registered_while_recruiting
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal pessary implantation on quality of life, sexual self-efficacy and clinical management of care in women with uterine prolapse
Public title
The effect of pessary on the clinical care of women with prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 45-60 years
Married women and women living together with their husbands
Literacy
Willingness and interest in participating in the study
Minimal first-degree prolapse
Tendency to use pessary instead of surgery
Lack of vaginitis
Exclusion criteria:
Having vaginal discharge and infection and the patient's unwillingness For pessary placement..
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehtan University of Medical Sciences
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat),
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-04-10, 1401/01/21
Ethics committee reference number
IR.TUMS.FNM.REC.1401.002
Health conditions studied
1
Description of health condition studied
Uterine prolapse
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Correction of uterine prolapse
Timepoint
At the beginning of the study (before the intervention) and once 8 weeks after the intervention
Method of measurement
Pelvic Organ Prolapse Quantification (POP-Q) System
Secondary outcomes
1
Description
Quality of life and sexual self-efficacy and management of patient clinical care
Timepoint
Once at the beginning of the study (before the intervention) and once 8 weeks after the intervention
Method of measurement
Quality of Life Questionnaire in Women with Prolapse (P-QOL), Vaziri and Lotfi Self-Efficacy Questionnaire, PGI Three-Question Scale Questionnaire, Researcher-Managed Clinical Care Questionnaire
Intervention groups
1
Description
Intervention group: The intervention group are those who have uterine prolapse and tend to have a pessary implantation and meet the inclusion criteria. For this group, a silicone device called a pessary is used to treat uterine prolapse. This device is available in different sizes and models and is a non-invasive method for patients whose choice is not surgery. In this study, two types of Marland and ring with support are used. And the choice of pessary depends on the patient's examination. For grade 1 and 2 prolapse, a ring with support is used, and for grade 3 and 4 prolapse, a Marland . Sex is possible in two types of pessarys at the same time. The pessary is placed after the necessary training and filling out the questionnaire based on the patient's examination and 8 weeks later she returns again for control and re-examination.
Category
Treatment - Devices
2
Description
Control group: There are people who have uterine prolapse but for personal reasons do not want to have a pessary. These patients are given the necessary training on pessary and placement and no treatment is performed for them. vaginal examination is performed and the type of prolapse is recorded. The questionnaire is filled out by these patients at the first visit and patient follow-up is maintained by telephone at 4 weeks after placement and 8 weeks after placement.