Comparison of the effect of Tamsulosin, Solifenacin and their combination in the treatment of double J stent-related urinary symptoms in patients with ureteral stones

to evaluate the effect of Tamsulosin, Solifenacin and their combination in the treatment of double J stent-related urinary tract symptoms in patients with ureteral stones

A phase 3, single-blinded, sham-controlled randomized clinical trial (RCT) with the parallel-groups design, on 80 patients. Simple individual randomization was done using random numbers table and sealed envelopes.

The study was performed in the Ghaem hospital, Mashhad, Iran. It was a single-blind RCT in which the research participants were blinded to the randomization. Each group of patients received the allocated medication following transurethral lithotripsy and double J stent placement. The Ureteral Stent Symptoms Questionnaire (USSQ) questionnaire was used to evaluate the double J stent-related urinary tract symptoms after 2 weeks of stent placement.

Inclusion criteria include the following: age 20 to 60 years, candidate for unilateral stent implantation following TUL (trans ureteral lithotripsy) and informed consent. Exclusion criteria include: history of surgery on the urinary system, urethroscopy or bilateral double j implantation, history of LUTS symptoms following BPH or other urinary tract diseases such as neurogenic bladder and overactive bladder, concomitant use of anti-adrenergic and anti-urinary drugs Cholinergic, pregnancy, drug allergies and finally the occurrence of major complications following surgery

patients are randomized into 4 groups receiving the following medications respectively: Tamsulosin 0.4 mg once daily, Solifenacin 5 mg once daily, Tamsulosin + Solifenacin with the same dosage, and placebo

double J stent-related lower urinary tract symptoms

simple individual randomization using sealed envelopes. In order to random allocation concealment by SNOSE method First, a random sequence assignment was created using the random number table method that created numbers from 00 to 99. Then based on the total sample size of the research, which is 80 people, 80 envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) were prepared and each of the random sequences created was recorded on a card and the cards were placed in envelopes. The order was placed. In order to maintain a random sequence on the outer surface of the envelopes, numbering was performed in the same way that A, B, C, and D drug groups were assigned in this envelopes. Accordingly, numbers between 00 to 24 were assigned to A group, number 25 to 49 B group, number 50 to 74 C group, and number 75 to 99 D group. Finally, the letter envelopes were glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of the participants who met the inclusion criteria, one of the envelopes was opened and the assigned group of the participant was revealed.

Research participants were blinded to the randomization. To maintain blindness, identical-looking medications and placebo without name were used.

All data is potentially shareable after unidentified individuals

Access period starts 6 months after the results are published

Researchers of medical universities

The results of this study are intended to help the medical community to help treat patients

Ghaem Hospital, Department of Urology akhavara@mums.ac.ir

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