To study the effect of tadalafil in improving urodynamic parameters in spinal cord injury patients: a randomized controlled trial
Abstract
Objectives: The aim of the study was to compare the effect of single dose Tadalafil 20 mg 2 h after administration on Urodynamic study (UDS) parameters and comparison with calcium+vit-D3 (control) in spinal cord injury (SCI).
Methods: Sixty-six SCI individuals with lower urinary tract symptoms (LUTS) and upper motor neuron bladder were randomized into Tadalafil group (n=33) and calcium+vitD3 group (n=33). UDS was done and parameters (maximum detrusor filling pressure [MDFP], maximum bladder capacity, and bladder compliance) were recorded at baseline and 2 h after administration of respective drugs in both groups and comparison was done.
Results: Statistically significant improvement in mean MDFP from 24.42±6.75 to 21.12±5.72 cm H2O (p < 0.001), mean maximum bladder capacity from 263.94±108.48 to 287.67±112.71 mL (p<0.001), and mean bladder compliance from 11.07±4.31 to 13.94±5.13 mL/cm H2O (p<0.001) was observed in Tadalafil group whereas in calcium+vit-D3 group, no significant improvement was observed. When we compared difference of mean of MDFP, bladder capacity, and bladder compliance between Tadalafil and calcium+vitD3 group, significant improvement (p<0.001) in Tadalafil group was noted as compared to calcium+vitD3 group.
Conclusions: Single dose of oral Tadalafil 20 mg has shown significant improvement in MDFP, bladder capacity, and bladder compliance in SCI individuals with LUTS as compared to control.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 33 participants or records.
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