Treatment of stress urinary incontinence with a percutaneously implantable wireless microstimulator device (NuStim®) plus pelvic floor muscle exercises: a pilot study
Main Article Content
Stress Urinary Incontinence, Percutaneously, Implantable, Wireless, Microstimulator
Objectives: To evaluate the utility and safety of pelvic floor muscle exercises in combination with a wireless percutaneously implantable microstimulator device (NuStim®) for the treatment of stress urinary incontinence.
Methods: In this prospective self-controlled pilot trial, three patients aged 35‒75 years with incontinence symptoms were treated by pelvic floor muscle exercises plus implantation of NuStim® from June 2017 to March 2019. The patients received 25 weeks of pelvic floor training, during which the patients’ incontinence was quantitatively assessed by a 1-h pad test. Self-reported scores were used to rate the effect of treatment in terms of the quality of daily life, with pelvic floor muscle strength evaluated on the modified Oxford scale at each follow-up visit.
Results: All three patients (2 males and 1 female) completed the trial without dropouts. The results showed that their incontinence symptoms were alleviated, as measured by a decrease in the normalized weight of the 1-h pad test, which presented a significant linear trend (P = 0.0021). An intragroup analysis revealed that all participants achieved statistically significant improvement in terms of the 1-h pad test score at 25 weeks as compared with pre-training findings. Nonetheless, no significant difference was found between the results of the other follow-up points and the baseline before treatment (P = 0.058). Comparison of the secondary outcome variable scores in each participant showed no significant difference at the conclusion of the study.
Conclusions: Use of the NuStim® during pelvic floor muscle exercises resulted in significant improvement in incontinence symptoms. The device was shown to be useful and safe as an adjunct to the pelvic floor training for the treatment of stress urinary incontinence.
Lamin E, Parrillo LM, Newman DK, Smith AL. Pelvic Floor Muscle Training: Underutilization in the USA. Curr Urol Rep. 2016 Feb;17(2):10. https://doi.org/10.1007/s11934-015-0572-0. PMID: 26757904.
An D, Wang J, Zhang F, Wu J, Jing H, Gao Y, et al. Effects of Biofeedback Combined With Pilates Training on Post-prostatectomy Incontinence. Urology. 2021 Sep;155:152-9. https://doi.org/10.1016/j.urology.2021.04.057. Epub 2021 Jun 26. PMID: 34186138.
Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. https://doi.org/10.1002/14651858.CD005654.pub4. PMID: 30288727; PMCID: PMC6516955.
Ong TA, Khong SY, Ng KL, Ting JR, Kamal N, Yeoh WS, et al. Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study. Urology. 2015 Sep;86(3):487-91. https://doi.org/10.1016/j.urology.2015.06.022. Epub 2015 Jul 2. Erratum in: Urology. 2017 Jan;99:294. PMID: 26142713.
Kane MJ, Breen PP, Quondamatteo F, ÓLaighin G. BION microstimulators: a case study in the engineering of an electronic implantable medical device. Med Eng Phys. 2011 Jan;33(1):7-16. https://doi.org/10.1016/j.medengphy.2010.08.010. Epub 2010 Nov 18. PMID: 21087890.
Loeb GE. Neural Prosthetics: A Review of Empirical vs. Systems Engineering Strategies. Appl Bionics Biomech. 2018 Nov 7;2018:1435030. https://doi.org/10.1155/2018/1435030. PMID: 30532801; PMCID: PMC6247642.
Huang X, Zheng K, Kohan S, Denprasert PM, Liao L, Loeb GE. Neurostimulation Strategy for Stress Urinary Incontinence. IEEE Trans Neural Syst Rehabil Eng. 2017 Jul;25(7):1068-78. https://doi.org/10.1109/TNSRE.2017.2679077. Epub 2017 Mar 7. PMID: 28287977.
Campbell SE, Glazener CM, Hunter KF, Cody JD, Moore KN. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2012 Jan 18;1:CD001843. https://doi.org/10.1002/14651858.CD001843.pub4. Update in: Cochrane Database Syst Rev. 2015;1:CD001843. PMID: 22258946.
Silva LA, Andriolo RB, Atallah ÁN, da Silva EM. Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery. Cochrane Database Syst Rev. 2014 Sep 27;2014(9):CD008306. https://doi.org/10.1002/14651858.CD008306.pub3. PMID: 25261861; PMCID: PMC7105906.