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The short-term false positives after sacral neuromodulation therapy : who, how many and why? A prospective descriptive single centre study

Lynn Ghijselings, Irina Verbakel (UGent) , Dirk Van de Putte (UGent) , François Hervé (UGent) , An-Sofie Goessaert (UGent) , Kim Pauwaert (UGent) , Stefan Engelberg, Ubi Van den Hombergh, Dimitri Beeckman (UGent) , Piet Pattyn (UGent) , et al.
(2023) CONTINENCE. 6.
Author
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Abstract
Aim: I. To describe the number of false positive cases (FP), their characteristics and reason of occurrence in sacral neuromodulation therapy (SNM). Methods: A multidisciplinary prospective single -centre study was conducted between March 2018 and December 2021 with a follow-up of 12 months. Patients with therapy-resistant pelvic organ dysfunctions, scheduled for a 2-staged SNM procedure at the Urology (UD) and Colorectal Surgery Department (CRD), were included. All patients completed bowel and bladder diaries at baseline and during the test phase. Patient global impression of change (PGIC) and satisfaction scores concerning urological (US) and bowel symptoms (BS) were surveyed at baseline, at 1, 6 and 12 months after implantation. Patient characteristics and diary outcomes between FP and true positive cases (TP) were compared using non-parametric statistical tests. SPSS 27.0 was used. Clinical trial registration: NCT05313984. Results: The FP ratio at one month follow-up was 16% (11/68), with a FP ratio of 13% ( N = 6/48 ) and 25% ( N = 5/20 ) for the urology patients and colorectal surgery patients, respectively. There were no significant differences in demographic characteristics between the FP and TP group ( p > 0,05), however there is a trend towards FP having worse baseline symptoms than TP. The FP group had a significant lower baseline and test phase 24 h diuresis ( p < 0,05), without having a significant different intake than the TP group. Conclusion: At one month after full implantation of a sacral neuromodulator, 16% of the patients showed loss of subjective success. These FP could not be predicted from demographic characteristics, most likely due to the small study population. Although not significant, FP seem to have worse symptoms at baseline than TP, with a significant lower diuresis regardless of fluid intake.
Keywords
Sacral neuromodulation, Pelvic floor, Incontinence, Placebo effect, Diuresis, FECAL INCONTINENCE, NERVE-STIMULATION, FOLLOW-UP, MULTICENTER, PLACEMENT, EFFICACY

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MLA
Ghijselings, Lynn, et al. “The Short-Term False Positives after Sacral Neuromodulation Therapy : Who, How Many and Why? A Prospective Descriptive Single Centre Study.” CONTINENCE, vol. 6, 2023, doi:10.1016/j.cont.2023.100701.
APA
Ghijselings, L., Verbakel, I., Van de Putte, D., Hervé, F., Goessaert, A.-S., Pauwaert, K., … Everaert, K. (2023). The short-term false positives after sacral neuromodulation therapy : who, how many and why? A prospective descriptive single centre study. CONTINENCE, 6. https://doi.org/10.1016/j.cont.2023.100701
Chicago author-date
Ghijselings, Lynn, Irina Verbakel, Dirk Van de Putte, François Hervé, An-Sofie Goessaert, Kim Pauwaert, Stefan Engelberg, et al. 2023. “The Short-Term False Positives after Sacral Neuromodulation Therapy : Who, How Many and Why? A Prospective Descriptive Single Centre Study.” CONTINENCE 6. https://doi.org/10.1016/j.cont.2023.100701.
Chicago author-date (all authors)
Ghijselings, Lynn, Irina Verbakel, Dirk Van de Putte, François Hervé, An-Sofie Goessaert, Kim Pauwaert, Stefan Engelberg, Ubi Van den Hombergh, Dimitri Beeckman, Piet Pattyn, and Karel Everaert. 2023. “The Short-Term False Positives after Sacral Neuromodulation Therapy : Who, How Many and Why? A Prospective Descriptive Single Centre Study.” CONTINENCE 6. doi:10.1016/j.cont.2023.100701.
Vancouver
1.
Ghijselings L, Verbakel I, Van de Putte D, Hervé F, Goessaert A-S, Pauwaert K, et al. The short-term false positives after sacral neuromodulation therapy : who, how many and why? A prospective descriptive single centre study. CONTINENCE. 2023;6.
IEEE
[1]
L. Ghijselings et al., “The short-term false positives after sacral neuromodulation therapy : who, how many and why? A prospective descriptive single centre study,” CONTINENCE, vol. 6, 2023.
@article{01GS8H5XFK58TCRM6QDVK4GGME,
  abstract     = {{Aim: I. To describe the number of false positive cases (FP), their characteristics and reason of occurrence in sacral neuromodulation therapy (SNM). Methods: A multidisciplinary prospective single -centre study was conducted between March 2018 and December 2021 with a follow-up of 12 months. Patients with therapy-resistant pelvic organ dysfunctions, scheduled for a 2-staged SNM procedure at the Urology (UD) and Colorectal Surgery Department (CRD), were included. All patients completed bowel and bladder diaries at baseline and during the test phase. Patient global impression of change (PGIC) and satisfaction scores concerning urological (US) and bowel symptoms (BS) were surveyed at baseline, at 1, 6 and 12 months after implantation. Patient characteristics and diary outcomes between FP and true positive cases (TP) were compared using non-parametric statistical tests. SPSS 27.0 was used. Clinical trial registration: NCT05313984. Results: The FP ratio at one month follow-up was 16% (11/68), with a FP ratio of 13% ( N = 6/48 ) and 25% ( N = 5/20 ) for the urology patients and colorectal surgery patients, respectively. There were no significant differences in demographic characteristics between the FP and TP group ( p > 0,05), however there is a trend towards FP having worse baseline symptoms than TP. The FP group had a significant lower baseline and test phase 24 h diuresis ( p < 0,05), without having a significant different intake than the TP group. Conclusion: At one month after full implantation of a sacral neuromodulator, 16% of the patients showed loss of subjective success. These FP could not be predicted from demographic characteristics, most likely due to the small study population. Although not significant, FP seem to have worse symptoms at baseline than TP, with a significant lower diuresis regardless of fluid intake.}},
  articleno    = {{100701}},
  author       = {{Ghijselings, Lynn and Verbakel, Irina and Van de Putte, Dirk and Hervé, François and Goessaert, An-Sofie and Pauwaert, Kim and Engelberg, Stefan and Van den Hombergh, Ubi and Beeckman, Dimitri and Pattyn, Piet and Everaert, Karel}},
  issn         = {{2772-9737}},
  journal      = {{CONTINENCE}},
  keywords     = {{Sacral neuromodulation,Pelvic floor,Incontinence,Placebo effect,Diuresis,FECAL INCONTINENCE,NERVE-STIMULATION,FOLLOW-UP,MULTICENTER,PLACEMENT,EFFICACY}},
  language     = {{eng}},
  pages        = {{9}},
  title        = {{The short-term false positives after sacral neuromodulation therapy : who, how many and why? A prospective descriptive single centre study}},
  url          = {{http://doi.org/10.1016/j.cont.2023.100701}},
  volume       = {{6}},
  year         = {{2023}},
}
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