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IRCT20221106056413N1 IRCT 2023-01-24 Shiraz University of Medical Sciences Effectiveness of platelet-rich plasma injection in treatment of stress urinary incontinence. Evaluating the effectiveness of pelvic floor biofeedback combined with autologous platelet-rich plasma injection in comparison to biofeedback as a monotherapy in rehabilitation of women with stress urinary incontinence. 2023-03-21 anticipated 48 Complete https://irct.ir/trial/66729 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible candidates to enter the study were assigned by random allocation using block randomization method. 48 recruited individuals were randomly assigned to one of the two groups of (intervention pelvic biofeedback and platelet rich plasma injection) and a control group (pelvic biofeedback), which will use block randomization with different block sizes. The size of the blocks will be a multiple of 2 and a divisor of 48 (2, 4, and 6). Initially, the block sizes are chosen randomly. Then for each block, different permutations are randomly determined by the Randomization Allocation Software. In each block, the number of people in the groups is equal, and blinding is used to not reveal the permutations in the last people of each block, Blinding description: In this study, patients will not know about how they are grouped and the details of the interventions performed. N/A Stress urinary incontinence. Intervention 1: Intervention group: 24 patients undergoing pelvic floor muscle rehabilitation treatment as 35-minute sessions, once a week, including 20 minutes of electrical stimulation with a vaginal probe with biphasic alternating current settings with a frequency of 5 Hz and a pulse width of 300 microseconds and current intensity from 1 to 100 The milliampere is adjusted to the level tolerated by the patient. Then 15 minutes of biofeedback with pelvic floor rehabilitation protocol will be performed for the patient in 4 weekly sessions (one session per week) for one month. In between sessions, the patient should perform Kegel exercises 6 times a day. In this group, after 4 sessions of pelvic rehabilitation, one shot of platelet-rich plasma in the anterior 1/3 wall of the vagina is performed. Three shots of platelet-rich plasma are performed at 4-week intervals. Before performing the procedure, a full blood test will be performed for the patients for platelet count, prothrombin time and check liver enzymes to rule out liver diseases, and a complete urine test. Then the injection process will be explained to the patients and patients with the following abnormalities will be excluded from the trial: 1- Platelet disorders 2- Thrombocytopenia 3- Hypofibrinogenemia 4- Patients who are not hemodynamically stable 5- Acute/chronic infection 6- Chronic liver disease 7- Patients who use anticoagulants 8- Malignancy. Eligible patients will be referred to the pain and rehabilitation clinic, and after obtaining informed consent from the patients, two 10 ml samples of blood will be taken, and after centrifugation, two 5 ml samples of platelet-rich plasma will be prepared for administration. Gel-based Royagen kits will be used to prepare platelet-rich plasma. The procedure is done with the patient placed in the lithotomy position, the desired area will be numbed with local anesthesia, and the injection process will be performed under sterile conditions. The prepared plasma will be injected using a 27G needle in the anterior 1/3 of the vaginal wall around the middle urethra, which is located about 1 cm behind the urethra, with a depth of 1.5 cm (2 ml of the solution in Behind the urethra and 1.5 ml on both sides of the urethra at 11, 12 and 1 clocks). This procedure will be repeated every 4 weeks for 3 months. Intervention 2: Control group: 24 patients will undergo pelvic floor muscle rehabilitation treatment as 35-minute sessions, once a week, including 20 minutes of electrical stimulation with a vaginal probe with biphasic alternating current settings with a frequency of 5 Hz and a pulse width of 300 microseconds and current intensity from 1 to 100 The milliampere is adjusted to the level tolerated by the patient. Then 15 minutes of biofeedback with pelvic floor rehabilitation protocol will be performed for the patient in 4 weekly sessions (one session per week) for one month. In between sessions, the patient should perform Kegel exercises 6 times a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Tayebeh Sadat Salehi Rihani
No. 2, East 14th Ave., Sabari Blvd., Tehran
Tehran Iran (Islamic Republic of) 1956819173 +98 21 2645 2587 tayebe.sadat.s.r@gmail.com Shiraz University of Medical Sciences scientific Tayebeh Sadat Salehi Rihani
No. 2, East 14th Ave., Sabari Blvd., Tehran
Tehran Iran (Islamic Republic of) 1956819173 +98 21 2645 2587 tayebe.sadat.s.r@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Women with clinical symptoms of urinary incontinence. Age 35-55 patients opting for non-surgical management. 20 years 70 years Female Stage>II prolapse Cervical dysplasia and malignancy Recurrent urinary tract infection Pelvic reconstruction surgery Pregnancy Abnormal uterine bleeding Anti-platelet drug medication Psychological disorders History of surgery due to urinary incontinence Uncontrolled diabetes Neurogenic urinary incontinence Urge urinary incontinence N39.3 Stress incontinence (female) (male) Treatment - Other Rehabilitation Intervention group: 24 patients undergoing pelvic floor muscle rehabilitation treatment as 35-minute sessions, once a week, including 20 minutes of electrical stimulation with a vaginal probe with biphasic alternating current settings with a frequency of 5 Hz and a pulse width of 300 microseconds and current intensity from 1 to 100 The milliampere is adjusted to the level tolerated by the patient. Then 15 minutes of biofeedback with pelvic floor rehabilitation protocol will be performed for the patient in 4 weekly sessions (one session per week) for one month. In between sessions, the patient should perform Kegel exercises 6 times a day. In this group, after 4 sessions of pelvic rehabilitation, one shot of platelet-rich plasma in the anterior 1/3 wall of the vagina is performed. Three shots of platelet-rich plasma are performed at 4-week intervals. Before performing the procedure, a full blood test will be performed for the patients for platelet count, prothrombin time and check liver enzymes to rule out liver diseases, and a complete urine test. Then the injection process will be explained to the patients and patients with the following abnormalities will be excluded from the trial: 1- Platelet disorders 2- Thrombocytopenia 3- Hypofibrinogenemia 4- Patients who are not hemodynamically stable 5- Acute/chronic infection 6- Chronic liver disease 7- Patients who use anticoagulants 8- Malignancy. Eligible patients will be referred to the pain and rehabilitation clinic, and after obtaining informed consent from the patients, two 10 ml samples of blood will be taken, and after centrifugation, two 5 ml samples of platelet-rich plasma will be prepared for administration. Gel-based Royagen kits will be used to prepare platelet-rich plasma. The procedure is done with the patient placed in the lithotomy position, the desired area will be numbed with local anesthesia, and the injection process will be performed under sterile conditions. The prepared plasma will be injected using a 27G needle in the anterior 1/3 of the vaginal wall around the middle urethra, which is located about 1 cm behind the urethra, with a depth of 1.5 cm (2 ml of the solution in Behind the urethra and 1.5 ml on both sides of the urethra at 11, 12 and 1 clocks). This procedure will be repeated every 4 weeks for 3 months. Control group: 24 patients will undergo pelvic floor muscle rehabilitation treatment as 35-minute sessions, once a week, including 20 minutes of electrical stimulation with a vaginal probe with biphasic alternating current settings with a frequency of 5 Hz and a pulse width of 300 microseconds and current intensity from 1 to 100 The milliampere is adjusted to the level tolerated by the patient. Then 15 minutes of biofeedback with pelvic floor rehabilitation protocol will be performed for the patient in 4 weekly sessions (one session per week) for one month. In between sessions, the patient should perform Kegel exercises 6 times a day. Stress urinary incontinence. Timepoint: The effectiveness of platelet-rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on women suffering from stress urinary incontinence. Method of measurement: International Consultation on Incontinence Questionnaire- Female Lower Urinary Tract Symptom (ICIQ-FLUTS) long form and short form. Sexual Function. Timepoint: The effectiveness of platelet-rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on sexual function of women suffering from stress urinary incontinence. Method of measurement: Female Sexual Function Index Pelvic incontinence Sexual Questionnaire-12. Quality of life. Timepoint: The effectiveness of platelet-rich plasma injection and pelvic floor biofeedback after 4 weekly sessions of biofeedback and 3 monthly sessions of PRP shots on quality of life of women suffering from stress urinary incontinence. Method of measurement: International Consultation on Incontinence Questionnaire- Quality of Life (ICIQ-QOL). Shiraz University of Medical Sciences Approved 2022-01-30 Ethics committee of Shiraz University of Medical Sciences Physical & Rehabilitation Medicine department, Faghihi hospital, Zand Street Shiraz Fars Iran (Islamic Republic of)