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IRCT20220906055897N1 IRCT 2022-10-08 Tehran University of Medical Sciences The effectiveness of vaginal radiofrequency in preventing the prolapse of pelvic organs after surgery A clinical trial to compare the effectiveness of the vaginal radiofrequency with placebo in preventing the prolapse of pelvic organs after surgery 2022-10-23 anticipated 60 Complete https://irct.ir/trial/65756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Pelvic organ prolapse. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Parivash Jelodarian provides the data analysis to the applicants via email: parivash1359@gmail.com How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Parivash Jelodarian
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 parivash1359@gmail.com Tehran University of Medical Sciences scientific Parivash Jelodarian
Imam Khomeini Hospital, Dr. Gharib Street, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 parivash1359@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with pelvic organ prolapse no limit no limit Female 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 N81 Female genital prolapse Treatment - Devices Treatment - Devices 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. 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. 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). Quality of life. Timepoint: Before, 6, 10, 14 and 18 weeks after surgery. Method of measurement: Pelvic floor distress inventory (PFDI-20). Sexual satisfaction. Timepoint: Before, 6, 10, 14 and 18 weeks after surgery. Method of measurement: The female sexual function index (FSFI). Tehran University of Medical Sciences Approved 2022-08-30 Ethical committee of Imam Khomeini Hospital, Tehran University of Medical Sciences Dr. Gharib Street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)