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

BMC Urology, 2014 · DOI: 10.1186/1471-2490-14-65 · Published: August 13, 2014

Urology Neurology Research Methodology & Design

Simple Explanation

This study aims to determine if sacral neuromodulation (SNM) is an effective treatment for neurogenic lower urinary tract dysfunction (LUTD). SNM is a well-established treatment for non-neurogenic LUTD, but its effectiveness for patients with neurological conditions is unclear. The study involves a double-blind, placebo-controlled trial where patients receive either active SNM or a sham stimulation. The researchers will monitor the success of SNM based on bladder diary variables and other outcome measures. The results of this study could revolutionize the management of neurogenic LUTD if SNM proves to be effective for this patient population. This could provide a minimally invasive and reversible treatment option.

Study Duration

2 months double-blind sacral neuromodulation phase

Participants

60 patients with refractory neurogenic lower urinary tract dysfunction

Evidence Level

Level 1: Prospective, randomized, placebo-controlled, double-blind multicenter trial

Key Findings

1
The primary outcome measure is the success of sacral neuromodulation, defined as at least a 50% improvement in key bladder diary variables compared to baseline.
2
Secondary outcome measures include adverse events, urodynamic parameters, questionnaires (Qualiveen, FSFI/IIEF), and the costs associated with sacral neuromodulation.
3
The study hypothesizes that SNM will lead to at least a 35% increase in the success rate compared to placebo stimulation within two months.

Research Summary

The study is designed to evaluate the efficacy and safety of sacral neuromodulation (SNM) for treating patients with refractory neurogenic lower urinary tract dysfunction (LUTD) through a prospective, randomized, placebo-controlled, double-blind multicenter clinical trial. Patients will undergo a prolonged SNM testing phase, and if successful, will have a neuromodulator implanted. They will then be randomized to either SNM ON or SNM OFF for a two-month double-blind phase before unblinding and activating the neuromodulator in all patients. The primary outcome is the success of SNM based on improvement in bladder diary variables, with secondary outcomes including adverse events, urodynamic parameters, questionnaires, and costs.

Practical Implications

Clinical Practice

If SNM proves effective for neurogenic LUTD, it could become a valuable treatment option, potentially reducing the need for more invasive procedures like bladder augmentation or urinary diversions.

Patient Outcomes

Successful SNM may enable voiding without intermittent catheterization, improving the quality of life for patients who cannot perform self-catheterization.

Neurology Awareness

The trial aims to increase awareness of LUTD in neurological disorders and the effectiveness of SNM as a treatment option within the neurology discipline.

Study Limitations

1
The number of investigated patients in previous studies is low with high between-study heterogeneity.
2
There is a lack of randomized controlled trials for sacral neuromodulation in neurogenic LUTD.
3
Assessing efficacy and safety of SNM for neurogenic LUTD, it is essential to be aware of the fact that these patients usually have undergone multiple failed previous treatments.

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