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IRCT20210214050354N1 IRCT 2022-06-26 Iran University of Medical Sciences Comparison of the efficacy of traditional method and modified technique for Botulinum injection in overactive bladder Comparison of urodynamic results of Minimistic intra-detrusor Botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active bladder 2021-02-19 anticipated 78 Complete https://irct.ir/trial/54300 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balance block randomization method : -In the present study we used Block randomization that is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. The basic idea of block randomization is to divide potential patients into m blocks of size 2n, randomize each block such that n patients are allocated to A and n to B. then choose the blocks randomly. This method ensures equal treatment allocation within each block if the complete block is used. -We consist a 3 columns table in Excel . First one is patients' numbers in order to enter the study . Second one is for their randomized group of intervention ( A or B ) and the last one is for the codes we will give to patients to make them and the analyzers blind about types of interventions , Blinding description: 1)Patients 2)Observers who evaluate patients 4-6 weeks after procedures by urodynamic 3) Methodologist who analyzes the final data. 3 Idiopathic overactive bladder. Intervention 1: Control group: As traditional method , spinal or general anesthesia is used. Patients will be hospitalized at least for one day after procedure . In each injection, 0.5 cc Botox are applied by injection at 20 sites of bladder detrusor muscle, mostly in posterior and lateral walls, using Cystoscope . A 500 IU Dysport vial is diluted in 10 cc normal saline for injections. Intervention 2: Intervention group: in Minimistic or the modified method , an oral or IV sedative will be used before procedure. Then 100 cc Lidocaine 2% will be injected in bladder using a 14F Foley catheter. After 15-20 minutes a diluted 500 IU Dysport will be injected at 5-6 main sites, mostly in posterior and lateral walls of bladder, using Cystoscope. Yes - There is a plan to make this available What will be shared: All data including age , sex and all urodynamic study results can be shared after eliminating private information of the patients. When: September 2022 To whom: Academic researchers Conditions: 1)For research only 2)A researcher or an organization who aim to use the results of the present study must precisely refer to this RCT in details. Where to obtain: Email address : n.soleimanifard@gmail.com How to obtain: 1)Evaluating the qualification of the applicants 2)Ensuring that the precise title and information of the current study will be mentioned in their studies. 3)After publishing the results as an article, all researchers can benefit from the published manuscript. We also will provide the pdf of the article should a researcher ask at later stages. Comments:
public Maryam Emami
Hasheminejad kidney center , Valinezhad St, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۹۶۹۷۱۴۷۱۳ +98 21 8116 1532 emami59658@yahoo.com Iran University of Medical Sciences scientific Maryam Emami
Hasheminejad kidney center , Valinezhad St, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۹۶۹۷۱۴۷۱۳ +98 21 8116 1532 emami59658@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Idiopathic overactive bladders resistant to anticholinergic drugs taking at least four weeks. Anticholinergic medication intolerance due to side effects Anticholinergic contraindications 18 years no limit Female Neurogenic bladder due to CVA , Multiple sclerosis, Spinal cord injury , head trauma , Parkinson , disc herniations . Severe bladder outlet obstruction Recurrent UTI Urinary tract anomalies Previous bladder surgery History of pelvic radiation History of pelvic malignancies Pregnancy Age < 18 years old Male N00-N99 disease of the genitourinary system Treatment - Surgery Treatment - Surgery Control group: As traditional method , spinal or general anesthesia is used. Patients will be hospitalized at least for one day after procedure . In each injection, 0.5 cc Botox are applied by injection at 20 sites of bladder detrusor muscle, mostly in posterior and lateral walls, using Cystoscope . A 500 IU Dysport vial is diluted in 10 cc normal saline for injections. Intervention group: in Minimistic or the modified method , an oral or IV sedative will be used before procedure. Then 100 cc Lidocaine 2% will be injected in bladder using a 14F Foley catheter. After 15-20 minutes a diluted 500 IU Dysport will be injected at 5-6 main sites, mostly in posterior and lateral walls of bladder, using Cystoscope. Comparison of urodynamic results of Minimistic intra-detrusor botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active bladder. Timepoint: Urodynamic study before Botulinum injection and after 4-6 weeks post injection. Method of measurement: Urodynamic study. Assessing the mean of maximum detrusor pressure in filling phase in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of maximum detrusor pressure in filling phase in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Comparison of the mean of maximum detrusor pressure in filling phase in both Minimistic and traditional methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of each detrusor over-activity duration in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of each detrusor over-activity duration in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Comparison of the mean of each detrusor over-activity duration in both Minimistic and traditional methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of bladder capacity in beginning of each detrusor over-activity in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of bladder capacity in beginning of each detrusor over-activity in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Comparison of the mean of bladder capacity in beginning of each detrusor over-activity in both traditional and Minimistic methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of functional bladder capacity in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of functional bladder capacity in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Comparison of the mean of functional bladder capacity in both traditional and Minimistic methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of maximum bladder capacity in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Assessing the mean of maximum bladder capacity in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Comparison of the mean of maximum bladder capacity in both traditional and Minimistic methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study. Iran University of Medical Sciences Approved 2021-02-27 Ethics committee of Iran university of medical science Hasheminezhad kidney center Hospital , Valinezhad street , Valiasr BLVD, Tehran Tehran Tehran Iran (Islamic Republic of)