Comparison of the therapeutic effects of posterior tibial nerve stimulation and the anticholinergic drug sulifenacin in patients with hyperactive bladder

Comparison of the therapeutic effects of posterior tibial nerve stimulation and the anticholinergic drug sulifenacin in patients with hyperactive bladder

A clinical trial with a control group, with a parallel group; A single-blind, randomized, phase III study on 118 patients. A block method was used for randomization.

This study is conducted in Ghaem Mashhad Hospital, Razavi Khorasan Province. 118 patients with symptoms of urinary urgency, urinary incontinence, nocturnal enuresis and frequency of urination referred to Qaim Hospital (Aj) in 1402 were randomly divided into two intervention or control groups (A-B). At the beginning and end of the study, the average quality of life score and overactive bladder symptoms are evaluated.In this study, the outcome assessor will be blinded.

The study population consisted of 118 patients with complaints of urinary urgency, urinary incontinence, nocturnal enuresis and frequent urination, who referred to Ghaem Hospital in 1402. Inclusion criteria: having informed consent to enter the study, urinating more than 8 times in 24 hours, at least 6 months had passed since the onset of symptoms. Exclusion criteria: refusal to continue the plan, pregnancy, history of surgery to treat urinary incontinence, treatment with anticholinergic drugs.

The study groups are divided into two groups, intervention group (A): for 12 weeks, 2 sessions every week and each session for 30 minutes under the treatment of posterior tibial nerve stimulation or control (B): patients treated with the anticholinergic drug visol solifenacin with The dose is 5 mg once a day for 12 weeks.

Mean quality of life score and frequency distribution of overactive bladder symptoms

Placement of patients in two intervention and control groups by simple random block method into two groups where each person in one of the intervention group (A): treated with stimulation of the posterior tibial nerve or control and group (B): patients treated with anti-inflammatory drugs Cholinergic visol solifenacin will be placed. First, blocks of four were created as AABB, ABAB, BABA, BBAA, ABBA, BAAB. Blocks are placed in sealed envelopes. Then one of these envelopes is randomly removed for the first patient and the placement of the next 3 patients in each of the following groups is determined. Then randomization is done for other patients as well.

Outcome evaluator: The study manager (4th year urology assistant) will evaluate and analyze the data without knowing the placement of the patients in the study groups.