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IRCT20220623055260N1 IRCT 2022-07-08 Mashhad University of Medical Sciences The effect of tadalafil on spinal cord injury patients Evaluation of Tadalafil Effects on Function of Detrusor Muscle in Hypo-contractile Bladder of Patients Suffering From Spinal Cord Injury 2022-09-23 anticipated 12 Complete https://irct.ir/trial/64441 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Flaccid neuropathic bladder. Intervention group: for 3 months, Tadalafil 5 mg from Hashtgerd Pharmaceutical Company's Prucial brand in the amount of 45 pills is given to them every other night (this pill from Hashtgerd's Prucial brand is the only brand available in the Iranian pharmaceutical market) and six months later, Urodynamics re-evaluations are performed in them.. 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 Mohammad Ghorbani
No. 251, 22 Bahman' 27, 22 Bahman St, Fariman Town
Fariman Iran (Islamic Republic of) 9391877186 +98 51 3462 6165 GhorbaniMH951@mums.ac.ir Mashhad University of Medical Sciences scientific Mahmoud Tavakkoli
Urology Department, Emam Reza Hospital, Ahmadabad Boulevard
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2833 tavakkolim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All male patients between the ages of 18-55 years old Suffering from hypocontractile neurogenic bladder as a result of spinal cord trauma At least 6 months passed from spinal cord trauma Having hypocontractile bladder in the Urodynamic testing 18 years 55 years Male lack of informed consent History of sensitivity to phosphodiesterase 5 inhibitors History of taking drugs containing nitrate compounds Heart problems History of priapism N31.2 Flaccid neuropathic bladder, not elsewhere classified Treatment - Drugs Intervention group: for 3 months, Tadalafil 5 mg from Hashtgerd Pharmaceutical Company's Prucial brand in the amount of 45 pills is given to them every other night (this pill from Hashtgerd's Prucial brand is the only brand available in the Iranian pharmaceutical market) and six months later, Urodynamics re-evaluations are performed in them. Bladder contraction index (BCI). Timepoint: Before of beginning of the intervention and 3 or 6 months after the starting intervention. Method of measurement: urodynamic study. Volume factor of excreted urine. Timepoint: Before of beginning of the intervention and 3 or 6 months after the starting intervention. Method of measurement: urodynamic study. Urinary residue. Timepoint: Before of beginning of the intervention and 3 or 6 months after the starting intervention. Method of measurement: urodynamic study. Mashhad University of Medical Sciences Approved 2022-04-26 Research Ethics Committee,Mashhad university of medical science East door of Ferdowsi University, Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)