Abstract
Purpose
This study aimed to seek predictive factors and develop a predictive tool for sacral nerve modulation (SNM) implantation in patients with non-obstructive urinary retention and/or slow urinary stream (NOUR/SS).
Methods
This study was designed as a retrospective study including all patients who have undergone a two-stage SNM for NOUR/SS between 2000 and 2021 in 11 academic hospitals. The primary outcome was defined as the implantation rate. Secondary outcomes included changes in bladder emptying parameters. Univariate and multivariable logistic regression analysis were performed and determined odds ratio for IPG implantation to build a predictive tool. The performance of the multivariable model discrimination was evaluated using the c-statistics and an internal validation was performed using bootstrap resampling.
Results
Of the 357 patients included, 210 (58.8%) were finally implanted. After multivariable logistic regression, 4 predictive factors were found, including age (≤ 52 yo; OR = 3.31 CI95% [1.79; 6.14]), gender (female; OR = 2.62 CI95% [1.39; 4.92]), maximal urethral closure pressure (≥ 70 cmH2O; OR: 2.36 CI95% [1.17; 4.74]), and the absence of an underlying neurological disease affecting the lower motor neuron (OR = 2.25 CI95% [1.07; 4.76]). Combining these factors, we established 16 response profiles with distinct IPG implantation rates, ranging from 8.7 to 81.5%. Internal validation found a good discrimination value (c-statistic, 0.724; 95% CI 0.660–0.789) with a low optimism bias (0.013). This allowed us to develop a predictive tool (https://predictivetool.wixsite.com/void).
Conclusion
The present study identified 4 predictive factors, allowing to develop a predictive tool for SNM implantation in NOUR/SS patients, that may help in guiding therapeutic decision-making. External validation of the tool is warranted.
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Data availability
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Abbreviations
- BNI:
-
Bladder neck incision
- BPH:
-
Benign prostatic hyperplasia
- BVE:
-
Bladder voiding efficiency
- CISC:
-
Intermittent self‐catheterization
- DPE:
-
Deep pelvic endometriosis
- IPG:
-
Implantable pulse generator
- LMN:
-
Lower motor neuron
- MUCP:
-
Maximal urethral closure pressure
- OAB:
-
Overactive bladder
- PVR:
-
Post-void residual
- Q max :
-
Maximum urine flow rate
- SNM:
-
Sacral nerve modulation
- TURP:
-
Transurethral resection of the prostate
- UMN:
-
Upper motor neuron
- NOUR/SS:
-
Non-obstructive urinary retention and/or slow urinary stream
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Funding
No funding was received for conducting this study.
The Committee of Neuro-Urology of the French Association of Urology gave total support to conduct this collaborative project.
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Contributions
JN, VP, and XB contributed to concept and design. JN, IAA, TT, RF, IM, EB, BM, SG, and AD were involved in acquisition of data. JN, XB, M-A-V, XG, LW, EC-K, GK, AR, BP, CS, and CT performed analysis and interpretation of data. JN and XB drafted the manuscript. VP, SDW, PV, XG, CT, EC-K, GK, M-A-V, AD, LW, AR, BP, CS, CM, IA, TT, RF, IM, EB, BM, and SG performed critical revision of the manuscript. CM did statistical analysis. XB, VP, SDW, and PV were involved in supervision.
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Conflict of interest
Jordan NASRI, Intasar AL ASHIMI, Thibault TRICARD, Raphael FLEURY, Imad MATTA, Elsa BEY, Benoit MESNARD, Sarah GAILLET, Claire MARTIN, Xavier GAME, Gilles KARSENTY, Amélie DEMEESTERE, Véronique PHE, and Patrick VERMERSCH declare that they have no conflict of interest. Caroline THUILLIER received support from Coloplast, Hollister, B Braun, Medtronic, Abbvie, and Stimuli technology. Emmanuel CHARTIER-KASTLER received support from Boston Scientific, Medtronic, Coloplast, Convatec, BBraun, Uromems, and TBF (Tissue Bank of France). Marie-Aimée PERROUIN-VERBE received support from Medtronic, Abbvie, Ipsen, and Uromedica. Laurent WAGNER received support from Coloplast, Neomedic, and ABMedica. Alain RUFFION, Christian SAUSSINE, and Stefan DE WACHTER received support from Medtronic. Benoit PEYRONNET: Medtronic, Boston Scientific, Ipsen, IBSA, Pierre Fabre, Intuitive, Schwa-Medico, Abbvie. Xavier BIARDEAU received support from Medtronic, Ipsen, Abbvie, Coloplast, Hollister, BD, and Convatec.
Research involving human participants
In France, clinical retrospective studies focusing on human participants require a commitment to comply to the reference methodology MR-004 through a declaration to the French Advisory Committee on Information Processing in Material Research in the Field of Health (Commission Nationale Informatique et Liberté – CNIL) through the Data Protection Officer (DPO) of the promoting center. The reference methodology MR-004 provides a framework for the processing of personal data for the purposes of studies relating to the re-use of data. The present retrospective study has therefore been declared to the DPO of Lille University Hospital under the reference DEC21-242.
Informed consent
In France, retrospective clinical studies involving human participants require the sponsor to disseminate information to patients whose data will be used in this study, and to give patients the opportunity to object to the use of their data. Thus, in this retrospective study, all patients whose data were to be reused were sent an information note and an objection document.
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Nasri, J., Al Ashimi, I., Tricard, T. et al. Development of a predictive tool for sacral nerve modulation implantation in the treatment of non-obstructive urinary retention and/or slow urinary stream: a study from the Neuro-Urology Committee of the French Association of Urology. World J Urol 41, 3075–3082 (2023). https://doi.org/10.1007/s00345-023-04638-y
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DOI: https://doi.org/10.1007/s00345-023-04638-y