• Lynn Ghijselings, Irina Verbakel, George Bou Kheir, Dirk Van de Putte, François Hervé, An-Sofie Goessaert, Kim Pauwaert, Dimitri Beeckman, Melissa Ooms, and Karel Everaert.
• Department of Urology, European Reference Network Accredited Centrum, Ghent University Hospital, Ghent, East-Flanders, Belgium. Electronic address: lynn.ghijselings@ugent.be.
• Neuromodulation. 2024 Jun 5.

ObjectivesSacral neuromodulation (SNM) has evolved as a therapeutic intervention for various pelvic floor dysfunctions. However, the traditional approach primarily assesses discipline-specific symptoms, potentially overlooking holistic symptom improvement. We aimed to investigate whether a more comprehensive evaluation of pelvic floor symptoms enhances the assessment of SNM's test phase.Material And MethodsA prospective single-center trial (Optimization of Lower Urinary Tract Symptoms study) assessed SNM efficacy from March 2018 to December 2021 in patients from the urology department (UD) and colorectal surgery department (CRD) with a follow-up of 12 months. Objective and subjective outcomes were examined using diaries and patient-reported outcome measures. Statistical analyses were conducted to determine predictive factors for treatment success, expressed by the patient global impression of change. SPSS 29.0 was used.ResultsA total of 85 participants were included, displaying concomitant pelvic floor symptoms. After the first phase, significant improvements on all pelvic floor domains questionnaires were seen for both patients from UD and those from CRD. Although improvements were observed in bladder and bowel diaries, the traditional criteria for success (≥50% improvement in diary variables) did not consistently correlate with the patients' global impression of change. The absolute reductions in bother sum scores from multiple domains were significant predictors for the patients' global impression of change, outperforming discipline-specific assessments. Patients from UD benefit from both a urologic and pelvic pain symptom evaluation, and those from CRD, from both a urologic and bowel symptom evaluation.ConclusionsSNM shows positive effects across various pelvic floor domains, even beyond the primary intended indication of implantation. The rather rigid approach of patient selection of discipline-specific symptoms alone can be questioned. A more comprehensive evaluation encompassing various pelvic floor symptoms with the emphasis on subjective outcome measures could enhance SNM's efficacy assessment during the test phase.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT05313984.Copyright © 2024 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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