Objective: This systematic review aimed to determine the efficacy and effectiveness of percutaneous tibial nerve stimulation (PTNS) on symptoms of overactive bladder (OAB) and pelvic organ disorders, pain, adverse events (AEs), and quality of life (QoL).
Methods: A literature search was performed in September 2011 in the databases MEDLINE, CINAHL, and EMBASE. Hand searching of references was conducted. Only randomized controlled trials (RCTs) and controlled clinical trials (CCTs) with adult patients were included.
Results: Seven studies met the eligibility criteria. Five RCTs indicated improvement (range 36.7–80%) on OAB symptoms, frequency, urgency, nocturia, and incontinence. One CCT reported improvement (mean 15.7) in 53% of the subjects on fecal incontinence (FI) symptoms on an FI Questionnaire (range 0–20). One RCT showed more than 50% improvement on pain (40%) and symptom scores (66.6%) in chronic pelvic pain (CPP). Limitations are the small amount, overall low quality, and variety in outcome measures of included studies. Only minor AEs were reported. No meta-analysis was performed as a consequence of heterogeneous data.
Conclusions: This systematic review provides evidence for the efficacy of PTNS on symptoms, pain, and QoL measures of OAB, FI and category IIIB CP/CPP. Evidence of effectiveness was found on symptoms and QoL for OAB. The total amount of seven included studies, from which even the most favorable study has some potential bias, is too small to draw firm conclusions. Independent high quality RCTs are necessary to confirm and delineate the range of therapeutic effects of PTNS in this region. PTNS is a safe intervention.