Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction

Abstract Background Sacral neuromodulation (SNM) has become an effective therapy for patients with lower urinary tract dysfunction (LUTD) who do not respond to conservative treatment. However, an effective treatment strategy for patients who fail SNM has not yet been identified. An option for LUTD is needed when the clinical response to the SNM diminishes. Case presentation A 51-year-old Chinese man presented to an outpatient clinic complaining of difficulty in urination for > 3 years. The patient also complained of urinary frequency and urgency, accompanied by perineal discomfort. He was diagnosed with LUTD based on his symptoms and previous examinations. The patient underwent sacral neuromodulation with a permanent implantable pulse generator (IPG) (provided free of charge by Chengnuo Medical Technology Co., Ltd.; General Stim, Hangzhou, China) in the left buttock, as he participated in the company’s clinical trial to test the long-term effects of IPG. He reported loss of efficacy of the device 3 months after the implantation. We performed bilateral electrical pudendal nerve stimulation (EPNS) therapy for him. After 2 weeks of treatment, he began to report smooth voiding within 2 h after EPNS, and a moderate improvement in urinary frequency, urgency, and perineal discomfort. After 4 weeks of EPNS, the patient reported > 50% improvement in his urination, evaluated with the short form of the International Consultation on Incontinence Questionnaire for Male Lower Urinary Tract Symptoms. He reported smooth voiding, moderate improvements in urinary frequency and urgency, and the disappearance of the perineal discomfort. He also reported improved sleep and erections. The patient was discharged after 8 weeks of EPNS treatment. Conclusion EPNS could be an option as an additional therapy for patients with LUTD who have failed SNM.

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Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design

International Neurourology Journal ◽

10.5213/inj.1938198.099 ◽

2020 ◽

Vol 24 (2) ◽

pp. 163-171 ◽

Cited By ~ 1

Author(s):

Hyun Hwan Sung ◽

Myung-Soo Choo ◽

Joon Chul Kim ◽

Jang Hwan Kim ◽

Kyu-Sung Lee

Keyword(s):

Urinary Tract ◽

Lower Urinary Tract ◽

Mean Difference ◽

Lower Urinary Tract Dysfunction ◽

Therapeutic Drug ◽

Efficacy And Safety ◽

Double Blind ◽

Parallel Group ◽

Study Results ◽

Lower Urinary

Purpose: The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients with neurogenic lower urinary tract dysfunction (LUTD).Methods: This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy, parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primary endpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment.Results: One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil (-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P<0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis of neurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safety profiles, including treatment emergent adverse events.Conclusions: Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.

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