Study design, materials and methods
To determine the effectiveness of PTNS as a treatment option for fecal incontinence, a systematic review methodology was used. To conduct the systematic review, a number of PubMed, EMBAS, and web of science and the Cochrane Library used to gather past studies in this field. These articles have appeared in peer-reviewed journals. The following keywords were entered into the search engine: “PTNS Bowel Control Treatment Outcomes Clinical Trials Randomized controlled trials (RCTs) Meta-analysis Long-term Follow-up Therapeutic Efficacy Patient-reported outcomes Adverse effects Neurostimulation therapy Quality life fecal incontinence Neuromodulation Tibial nerve stimulation. "
Interpretation of results
Significant data regarding the efficacy of percutaneous tibial nerve stimulation (PTNS) as a treatment option for fecal incontinence (FI) is provided by the presented research studies, with each study highlighting a distinct facet of the treatment's potential and effectiveness.
Promising findings were obtained from the study that assessed the long-term effectiveness of PTNS over a number of years by conducting a prospective, interventional trial.Bosch-Ramírez, M., et al. (2023) , (Carrillo, R. R., et al. (2021). It noted that PTNS, administered over a year in phases, led to optimal responses in a significant proportion of patients, with a notable percentage remaining optimal responders even at the 36-month mark. It's interesting to note that baseline variables like Wexner scores and the length of symptoms were found to be predictive of favorable reactions to PTNS with motor response during procedure. According to this, individuals with FI who are not responding to conservative therapy may benefit from PTNS over time, which could lessen the need for more invasive procedures.
Conversely, the aim of the comprehensive evaluation was to assess the effectiveness of PTNS in the context of various research studies and methodologies. (van der Wilt, A. A., et al (2017) , (Zyczynski, H. M., ert al. (2021). It discovered a considerable body of evidence demonstrating the usefulness of PTNS in improving treatment results, incontinence severity, and quality of life . Notably, the review found that PTNS was helpful in reducing the number of incontinence events while extending deferral time for defecation. However, it also recognized the necessity for long-term interventions to extend the effects of PTNS, emphasizing the importance of continued treatment in preserving advantages over time.
In contrast, the randomized controlled trial (RCT) comparing PTNS with sham stimulation for FI in women yielded mixed results (Horrocks, E. J., et al. (2014), (Hounsome, N., & Roukas, C. (2018), (Waked, I. S., & Seyam, M. K. (2018). While PTNS showed a reduction in symptoms after 12 weeks of treatment, this improvement did not significantly differ from the sham group. This suggests that while PTNS may offer some clinical benefit, its superiority over sham stimulation remains unclear based on these findings. However, it's important to note that this study focused specifically on women with FI refractory to first-line treatments, indicating a need for further research to determine the broader efficacy of PTNS across different patient populations.
Furthermore, The requirement of high-quality data for noninvasive second-line treatments for FI in the Neuromodulation for Accidental Bowel Leakage trial design is highlighted. By comparing it to sham stimulation and measuring multiple outcome indicators, the aim of this trial is to offer valuable insights into the efficacy and optimal maintenance therapy schedule of PTNS for refractory inadvertent bowel leakage.
Overall, while some studies suggest promising outcomes for PTNS in the treatment of FI, others highlight the need for further research to clarify its efficacy and determine its role in clinical practice. Further investigation, including larger RCTs and long-term follow-up studies, will be essential for fully understanding the potential benefits of PTNS and optimizing its use in the management of FI.