Study design and procedures in the incontinence post robot-assisted radical prostatectomy: anatomical and functional causes (IPA) – a prospective observational clinical trial

Authors

  • Katarina Koss Modig Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Rebecka Arnsrud Godtman Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Fredrik Langkilde Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Marianne Månsson Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
  • Jonas Wallström Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Johan Stranne Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden

DOI:

https://doi.org/10.2340/sju.v59.40051

Keywords:

Urinary incontinence, prostate cancer, robot assisted radical prostatectomy, prospective clinical trial

Abstract

Objective: To describe the study design and procedures of the incontinence post robot- assisted radical prostatectomy, anatomical and functional causes (IPA) trial. This trial aims to identify and study patient and procedure specific factors leading to urinary incontinence post robot-assisted laparoscopic radical prostatectomy (RALP).

Material and methods: The IPA study is a prospective, multicentre, open non-randomised surgical trial, including patients prior to RALP and registered on-line (ISRCTN67297115). IPA is administered from the Department of Urology at Sahlgrenska University Hospital, Gothenburg, Sweden. Patients undergo an anatomical and functional evaluation using magnetic resonance imaging (MRI), urodynamics including cystometry, pressure-flow and urethral pressure profile, and dynamic transrectal ultrasound prior to and 3 months after RALP. The incontinence data are gathered using patient reported outcome measure questionnaires. The primary endpoint is incontinence at 3 months after RALP, defined as need of any pad. The secondary endpoints are incontinence 12 months post RALP defined as need of any pad, and 3- and 12-months post RALP, defined as use of more than a safety pad.

Results: Until October 2023, 207 patients have been included of the stipulated 1,000, with an increasing rate of accrual. Out of these patients,187 have had a pre- and post-operative MRI and 177 have undergone pre- and post-operative urodynamics.

Conclusions: The design of the IPA study, together with promising accrual and coming multicentre inclusion, will hopefully result in the identification, and deeper understanding, of the various risk-factors for post-RALP incontinence. This could improve information and decision making regarding adequate treatment for patients with prostate cancer.

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References

Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. https://doi.org/10.3322/caac.21660 DOI: https://doi.org/10.3322/caac.21660

Database on in-house surgery [Internet]. 2024 [cited 02-01-2024]. Available from: https://sdb.socialstyrelsen.se/if_ope/val.aspx

Haglind E, Carlsson S, Stranne J, et al. Urinary incontinence and erectile dysfunction after robotic versus open radical prostatectomy: a prospective, controlled, nonrandomised trial. Eur Urol. 2015;68(2):216–225. https://doi.org/10.1016/j.eururo.2015.02.029 DOI: https://doi.org/10.1016/j.eururo.2015.02.029

Cazzaniga W, Godtman RA, Carlsson S, et al. Population-based, nationwide registration of prostatectomies in Sweden. J Surg Oncol. 2019;120(4):803–812. https://doi.org/10.1002/jso.25643 DOI: https://doi.org/10.1002/jso.25643

Du Y, Long Q, Guan B, et al. Robot-assisted radical prostatectomy is more beneficial for prostate cancer patients: a system review and meta-analysis. Med Sci Monit. 2018;24:272–287. https://doi.org/10.12659/MSM.907092 DOI: https://doi.org/10.12659/MSM.907092

Ficarra V, Novara G, Rosen RC, et al. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012;62(3):405–417. https://doi.org/10.1016/j.eururo.2012.05.045 DOI: https://doi.org/10.1016/j.eururo.2012.05.045

Wallerstedt A, Carlsson S, Nilsson AE, et al. Pad use and patient reported bother from urinary leakage after radical prostatectomy. J Urol. 2012;187(1):196–200. https://doi.org/10.1016/j.juro.2011.09.030 DOI: https://doi.org/10.1016/j.juro.2011.09.030

van Stam MA, Aaronson NK, Bosch J, et al. Patient-reported outcomes following treatment of localised prostate cancer and their association with regret about treatment choices. Eur Urol Oncol. 2020;3(1):21–31. https://doi.org/10.1016/j.euo.2018.12.004 DOI: https://doi.org/10.1016/j.euo.2018.12.004

Nyberg M, Sjoberg DD, Carlsson SV, et al. Surgeon heterogeneity significantly affects functional and oncological outcomes after radical prostatectomy in the Swedish LAPPRO trial. BJU Int. 2021;127(3):361–368. https://doi.org/10.1111/bju.15238 DOI: https://doi.org/10.1111/bju.15238

Carlsson S, Berglund A, Sjoberg D, et al. Effects of surgeon variability on oncologic and functional outcomes in a population-based setting. BMC Urol. 2014;14:25. https://doi.org/10.1186/1471-2490-14-25 DOI: https://doi.org/10.1186/1471-2490-14-25

Clements MB, Gmelich CC, Vertosick EA, et al. Have urinary function outcomes after radical prostatectomy improved over the past decade? Cancer. 2022;128(5):1066–1073. https://doi.org/10.1002/cncr.33994 DOI: https://doi.org/10.1002/cncr.33994

Godtman RA, Persson E, Cazzaniga W, et al. Association of surgeon and hospital volume with short-term outcomes after robot-assisted radical prostatectomy: nationwide, population-based study. PLoS One. 2021;16(6):e0253081. https://doi.org/10.1371/journal.pone.0253081 DOI: https://doi.org/10.1371/journal.pone.0253081

Lardas M, Grivas N, Debray TPA, et al. Patient- and tumour-related prognostic factors for urinary incontinence after radical prostatectomy for nonmetastatic prostate cancer: a systematic review and meta-analysis. Eur Urol Focus. 2022;8(3):674–689. https://doi.org/10.1016/j.euf.2021.04.020 DOI: https://doi.org/10.1016/j.euf.2021.04.020

Steineck G, Bjartell A, Hugosson J, et al. Degree of preservation of the neurovascular bundles during radical prostatectomy and urinary continence 1 year after surgery. Eur Urol. 2015;67(3):559–568. https://doi.org/10.1016/j.eururo.2014.10.011 DOI: https://doi.org/10.1016/j.eururo.2014.10.011

Dubbelman YD, Bosch JL. Urethral sphincter function before and after radical prostatectomy: systematic review of the prognostic value of various assessment techniques. Neurourol Urodyn. 2013;32(7):957–963. https://doi.org/10.1002/nau.22355 DOI: https://doi.org/10.1002/nau.22355

EAU – EANM – ESTRO – ESUR – ISUP – SIOG guidelines on prostate cancer [Internet]. 2023 [cited 02-02-2024]. Available from: https://uroweb.org/guidelines/prostate-cancer

van Dijk-de Haan MC, Boellaard TN, Tissier R, et al. Value of different magnetic resonance imaging-based measurements of anatomical structures on preoperative prostate imaging in predicting urinary continence after radical prostatectomy in men with prostate cancer: a systematic review and meta-analysis. Eur Urol Focus. 2022;8(5):1211–1225. https://doi.org/10.1016/j.euf.2022.01.015 DOI: https://doi.org/10.1016/j.euf.2022.01.015

Tutolo M, Rosiello G, Stabile G, et al. The key role of levator ani thickness for early urinary continence recovery in patients undergoing robot-assisted radical prostatectomy: a multi-institutional study. Neurourol Urodyn. 2022;41(7):1563–1572. https://doi.org/10.1002/nau.25001 DOI: https://doi.org/10.1002/nau.25001

Lee SE, Byun SS, Lee HJ, et al. Impact of variations in prostatic apex shape on early recovery of urinary continence after radical retropubic prostatectomy. Urology. 2006;68(1):137–141. https://doi.org/10.1016/j.urology.2006.01.021 DOI: https://doi.org/10.1016/j.urology.2006.01.021

Paparel P, Akin O, Sandhu JS, et al. Recovery of urinary continence after radical prostatectomy: association with urethral length and urethral fibrosis measured by preoperative and postoperative endorectal magnetic resonance imaging. Eur Urol. 2009;55(3):629–637. https://doi.org/10.1016/j.eururo.2008.08.057 DOI: https://doi.org/10.1016/j.eururo.2008.08.057

Mungovan SF, Sandhu JS, Akin O, et al. Preoperative membranous urethral length measurement and continence recovery following radical prostatectomy: a systematic review and meta-analysis. Eur Urol. 2017;71(3):368–378. https://doi.org/10.1016/j.eururo.2016.06.023 DOI: https://doi.org/10.1016/j.eururo.2016.06.023

Mungovan SF, Carlsson SV, Gass GC, et al. Preoperative exercise interventions to optimize continence outcomes following radical prostatectomy. Nat Rev Urol. 2021;18(5):259–281. https://doi.org/10.1038/s41585-021-00445-5 DOI: https://doi.org/10.1038/s41585-021-00445-5

Tomic K, Berglund A, Robinson D, et al. Capture rate and representativity of the national prostate cancer register of Sweden. Acta Oncol. 2015;54(2):158–163. https://doi.org/10.3109/0284186X.2014.939299 DOI: https://doi.org/10.3109/0284186X.2014.939299

Turkbey B, Rosenkrantz AB, Haider MA, et al. Prostate imaging reporting and data system version 2.1: 2019 update of prostate imaging reporting and data system version 2. Eur Urol. 2019;76(3):340–351. https://doi.org/10.1016/j.eururo.2019.02.033 DOI: https://doi.org/10.1016/j.eururo.2019.02.033

Rosier P, Schaefer W, Lose G, et al. International continence society good urodynamic practices and terms 2016: urodynamics, uroflowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. 2017;36(5):1243–1260. https://doi.org/10.1002/nau.23124 DOI: https://doi.org/10.1002/nau.23124

Guangyong Zou. A modified poisson regression approach to prospective studies with binary data Am J Eoidemiol. 2004 Apr 1;159(7):702-6. PMID: 15033648 https://doi.org/10.1093/aje/kwh090 DOI: https://doi.org/10.1093/aje/kwh090

Heijnsdijk EA, Wever EM, Auvinen A, et al. Quality-of-life effects of prostate-specific antigen screening. N Engl J Med. 2012;367(7):595–605. https://doi.org/10.1056/NEJMoa1201637 DOI: https://doi.org/10.1056/NEJMoa1201637

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Published

2024-09-30

How to Cite

Modig, K. K., Arnsrud Godtman, R., Langkilde, F., Månsson, M., Wallström, J., & Stranne, J. (2024). Study design and procedures in the incontinence post robot-assisted radical prostatectomy: anatomical and functional causes (IPA) – a prospective observational clinical trial. Scandinavian Journal of Urology, 59, 156–161. https://doi.org/10.2340/sju.v59.40051

Issue

Vol. 59 (2024)

Section

Original research article

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Copyright (c) 2024 Katarina Koss Modig, Rebecka Arnsrud Godtman, Fredrik Langkilde, Marianne Månsson, Jonas Wallström, Johan Stranne

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This work is licensed under a Creative Commons Attribution 4.0 International License.

Acta Chirurgica Scandinavica Society owns the copyright for all material published until Volume 57 (2023) unless otherwise specified. As from Volume 59 (2024) all published articles, unless otherwise specified, are published under CC-BY licences, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, with the condition of proper attribution to the original work. 

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