Comparison of urodynamic results of Minimistic intra-detrusor Botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active 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

Two arm parallel group randomized trial with blinded participants, postoperative care and outcome assessment of 78 patients. Randomization was centralized with balance block randomization using excel software.

Patients will be visited by urology residents in Tehran Hasheminezhad kidney center hospital and will be entered into trial according to inclusion and exclusion criteria All observers and analyzers are blind about type of interventions .

-Inclusion criteria: Females more than 18 years old with idiopathic over active bladder with no response to medical therapy or contraindicated ones or the ones who suffering from side effects -Exclusion criteria : Males , females under 18 y/o, overactive bladders due to neurogenic disease

-In traditional method ( control group ) after general or spinal anesthesia , 0.5 cc Botulinum toxin which has been diluted with 10 cc normal saline is injected into detrusor at 20 sites of bladder (base , laterals and posterior). -In Minimistic method the same diluted Botulinum is injected in 5-6 main sites ( base , laterals and posterior) of bladder under local anesthesia. For local anesthesia 100cc Lidocaine 2% is injected in bladder, 15-20 minutes prior to procedure.

Comparison of urodynamic results of Minimistic intra-detrusor botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active bladder

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 .

1)Patients 2)Observers who evaluate patients 4-6 weeks after procedures by urodynamic 3) Methodologist who analyzes the final data

All data including age , sex and all urodynamic study results can be shared after eliminating private information of the patients.

September 2022

Academic researchers

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.

Email address : n.soleimanifard@gmail.com

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.