To compare the effectiveness of the vaginal radiofrequency with placebo in preventing the prolapse of pelvic organs after surgery
Design
In this randomized and double-blind clinical trial, 60 patients will be randomly selected using blocks and randomized into parallel and control groups.
Settings and conduct
Patients candidate for prolapse surgery referring to Imam Khomeini Hospital, Tehran, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the vaginal radiofrequency and control will receive placebo treatment. The patients and person responsible for data collection are blind to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with pelvic organ prolapse.
Exclusion criteria: Patients with active or recurrent genital infection (genital herpes, candidiasis); recurrent urinary tract infection; history of pelvic radiotherapy or vaginal brachytherapy; history of reconstructive pelvic surgery.
Intervention groups
The intervention group will receive vaginal radiofrequency 6 weeks after prolapse surgery. The control group will receive vaginal radiofrequency vaginal radiofrequency without energy and on an off status 6 weeks after prolapse surgery.
Main outcome variables
degree of pelvic organ prolapse, quality of life and sexual satisfaction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220906055897N1
Registration date:2022-10-08, 1401/07/16
Registration timing:prospective
Last update:2022-10-08, 1401/07/16
Update count:0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Parivash Jelodarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 602 9855
Email address
parivash1359@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of the vaginal radiofrequency with placebo in preventing the prolapse of pelvic organs after surgery
Public title
The effectiveness of vaginal radiofrequency in preventing the prolapse of pelvic organs after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pelvic organ prolapse
Exclusion criteria:
Patients with active or recurrent genital infection (genital herpes, candidiasis)
Recurrent urinary tract infection
History of pelvic radiotherapy or vaginal brachytherapy
History of reconstructive pelvic surgery
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization base on statistical analysis system (SAS), computer software. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer do not know which groups are located. The samples in the intervention and control group did not know whether they received the the vaginal radiofrequency or placebo (without energy and on an off status) treatment. The statistician will receive questionnaires as anonymously and in form A and B, and he does not know which are intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Imam Khomeini Hospital, Tehran University of Medical Sciences
Street address
Dr. Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.127
Health conditions studied
1
Description of health condition studied
Pelvic organ prolapse
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
Primary outcomes
1
Description
The degree of pelvic organ prolapse
Timepoint
Before, 6, 10, 14 and 18 weeks after surgery
Method of measurement
The pelvic organ prolapse quantifications system (POP-Q)
2
Description
Quality of life
Timepoint
Before, 6, 10, 14 and 18 weeks after surgery
Method of measurement
Pelvic floor distress inventory (PFDI-20)
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before, 6, 10, 14 and 18 weeks after surgery
Method of measurement
The female sexual function index (FSFI)
Intervention groups
1
Description
Intervention group: The intervention group will receive vaginal radiofrequency 6 weeks after prolapse surgery, then three sessions with a one-month interval. Radiofrequency is equipped with an energy-harvesting integrated circuit, with 64 microneedles vaginal pen, 200 microns in diameter and 1 mm in length. The duration of each session will be 15 to 20 minutes.
Category
Treatment - Devices
2
Description
Control group: The control group will receive vaginal radiofrequency vaginal radiofrequency without energy and on an off status 6 weeks after prolapse surgery, then three sessions with a one-month interval. Radiofrequency is equipped with an energy-harvesting integrated circuit, with 64 microneedles vaginal pen, 200 microns in diameter and 1 mm in length. The duration of each session will be 15 to 20 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parivash Jelodarian
Street address
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
parivash1359@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Fakoorsaghieh
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Enqelab Street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6640 0059
Fax
Email
research@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parivash Jelodarian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
parivash1359@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parivash Jelodarian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
parivash1359@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parivash Jelodarian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
parivash1359@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Parivash Jelodarian provides the data analysis to the applicants via email: parivash1359@gmail.com
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.