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IRCT20130811014330N5 IRCT 2018-11-29 Mashhad University of Medical Sciences Effectiveness of hyaluronic acid for the treatment of interstitial cystitis Treatment of interstitial cystitis; clinical effectiveness of hydrodistention with intravesical hyaluronic acid (cystistat®) over hydrodistention alone 2017-04-21 anticipated 24 Complete https://irct.ir/trial/34300 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was used.patients were assigned to intervention and control groups using random assignment list generated by PASS software, Blinding description: In this study, the patients and the doctor were aware of the allocated treatment, so blinding was not possible. but the researcher who evaluated the questionnaires and the statistical analyst of the study were completely unaware about the treatment of each patient. 2-3 Interstitial cystitis / bladder pain syndrome. Intervention 1: Intervention group: Patients were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes. In the 12 patients of the intervention group, Cystistat® solution (40mg of sodium hyaluronate in a 50ml vial) produced by Mylan company was infused into the bladder through a catheter. patients had to keep the solution in their bladder for at least 30 minutes and place in different positions, then drained it by urinating. This procedure was done weekly for four weeks, then monthly until two months later. Intervention 2: Control group: The 12 patients of the control group were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes. 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 further information"
public Hamidreza Rahimi
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3800 2301 rahimihr@mums.ac.ir Mashhad University of Medical Sciences scientific Hamidreza Rahimi
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3800 2301 rahimihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Older than 18 years’ old Previously treated with a daily 25 mg of Amitriptyline for at least 1 month, and did not show any improvement in symptoms. 18 years no limit Female History of bacterial cystitis in the last 3 months History of active genital herpes History of vaginal cervical or uterine cancer History of diverticulum History of cyclophosphamide consumption History of bladder tuberculosis History of abdomen or pelvis radiotherapy Vaginitis symptoms History of bladder stones History of symptom relief with antimicrobials or anticholinergics Frequency of urination less than 8 times a day History of benign or malignant bladder tumors N30.1 Interstitial cystitis (chronic) Treatment - Drugs Treatment - Drugs Intervention group: Patients were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes. In the 12 patients of the intervention group, Cystistat® solution (40mg of sodium hyaluronate in a 50ml vial) produced by Mylan company was infused into the bladder through a catheter. patients had to keep the solution in their bladder for at least 30 minutes and place in different positions, then drained it by urinating. This procedure was done weekly for four weeks, then monthly until two months later. Control group: The 12 patients of the control group were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes. Frequency of urination. Timepoint: Baseline, 1 week, 1 month, and 3 months after intervention. Method of measurement: the O`Leary-Sant questionnaire. Urgency. Timepoint: Baseline, 1 week, 1 month, and 3 months after intervention. Method of measurement: the O`Leary-Sant questionnaire. Nocturia. Timepoint: Baseline, 1 week, 1 month, and 3 months after intervention. Method of measurement: the O`Leary-Sant questionnaire. Dysuria. Timepoint: Baseline, 1 week, 1 month, and 3 months after intervention. Method of measurement: the O`Leary-Sant questionnaire. Mashhad University of Medical Sciences Approved 2016-12-21 Ethics Committee of Mashhad University of Medical Sciences Faculty of Medicine, University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)