The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study
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. Patien...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Continence |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772973723001297 |
| _version_ | 1797803822447329280 |
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| author | Lynn Ghijselings Irina Verbakel Dirk Van de Putte François Hervé An-Sofie Goessaert Kim Pauwaert Stefan Engelberg Ubi Van den Hombergh D. Beeckman Piet Pattyn Karel Everaert |
| author_facet | Lynn Ghijselings Irina Verbakel Dirk Van de Putte François Hervé An-Sofie Goessaert Kim Pauwaert Stefan Engelberg Ubi Van den Hombergh D. Beeckman Piet Pattyn Karel Everaert |
| author_sort | Lynn Ghijselings |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-13T05:27:47Z |
| format | Article |
| id | doaj.art-c9d383ebdf924a818fcbc127856969c2 |
| institution | Directory Open Access Journal |
| issn | 2772-9737 |
| language | English |
| last_indexed | 2024-03-13T05:27:47Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Continence |
| spelling | doaj.art-c9d383ebdf924a818fcbc127856969c22023-06-15T04:57:52ZengElsevierContinence2772-97372023-06-016100701The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre studyLynn Ghijselings0Irina Verbakel1Dirk Van de Putte2François Hervé3An-Sofie Goessaert4Kim Pauwaert5Stefan Engelberg6Ubi Van den Hombergh7D. Beeckman8Piet Pattyn9Karel Everaert10Department of Urology, Ghent University Hospital, Ghent University, Ghent, Belgium; Correspondence to: Department of Urology, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.Department of Urology, Ghent University Hospital, Ghent University, Ghent, BelgiumDepartment of Colorectal Surgery, Ghent University Hospital, Ghent University, Ghent, BelgiumDepartment of Urology, Ghent University Hospital, Ghent University, Ghent, BelgiumDepartment of Urology, Ghent University Hospital, Ghent University, Ghent, BelgiumDepartment of Urology, Ghent University Hospital, Ghent University, Ghent, BelgiumMedtronic Intl Sarl, Tolochenaz, SwitzerlandMedtronic Intl Sarl, Tolochenaz, SwitzerlandUniversity Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, BelgiumDepartment of Colorectal Surgery, Ghent University Hospital, Ghent University, Ghent, BelgiumDepartment of Urology, Ghent University Hospital, Ghent University, Ghent, BelgiumAim:: 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.http://www.sciencedirect.com/science/article/pii/S2772973723001297Sacral neuromodulationPelvic floorIncontinencePlacebo effectDiuresis |
| spellingShingle | Lynn Ghijselings Irina Verbakel Dirk Van de Putte François Hervé An-Sofie Goessaert Kim Pauwaert Stefan Engelberg Ubi Van den Hombergh D. Beeckman Piet Pattyn Karel Everaert The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study Continence Sacral neuromodulation Pelvic floor Incontinence Placebo effect Diuresis |
| title | The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study |
| title_full | The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study |
| title_fullStr | The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study |
| title_full_unstemmed | The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study |
| title_short | The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study |
| title_sort | short term false positives after sacral neuromodulation therapy who how many and why a prospective descriptive single centre study |
| topic | Sacral neuromodulation Pelvic floor Incontinence Placebo effect Diuresis |
| url | http://www.sciencedirect.com/science/article/pii/S2772973723001297 |
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