Artificial urinary sphincter explained

Artificial urinary sphincter
Synonym:Inflatable artificial sphincter
Specialty:Urology
Icd10:0THC0LZ
Cpt:53445

An artificial urinary sphincter (AUS) is an implanted device to treat moderate to severe stress urinary incontinence, most commonly in men. The AUS is designed to supplement the function of the natural urinary sphincter that restricts urine flow out of the bladder.

Description

There are two types of artificial urinary sphincters:

The common theme among currently available designs is a mechanical constriction mechanism – an inflatable cuff filled with sterile saline solution and placed around the urethra which keeps the urethral lumen closed; this is due to the pressure produced inside the device and an externally accessible control pump mechanism placed between two skin layers of the scrotum (subdartos pouch) which allows the user to manually relieve the constriction to allow urination.

History

Frederic Foley was the first to describe an externally worn artificial urinary sphincter to treat urinary incontinence, published in 1947.[3] In 1972, F. Brantley Scott and colleagues from Baylor College of Medicine designed the first precursor of contemporary artificial urinary sphincter.[4] [5] The first AUS model on the market was the AMS 800 (Boston Scientific, Marlborough, MA), developed 50 years ago.[6] [7] It is a 3-component device with a cuff placed around the urethra, a pump inserted in the scrotum and a pressure generating reservoir placed in the pelvis, which comes as a kit to prepare and to fill up before implantation.[8]

Another AUS model is the ZSI 375 (Zephyr Surgical Implants, Geneva, Switzerland), introduced in 2008.[9] It is a one-piece two-part device with a cuff and a pump unit with an integrated spring; it comes in one piece, pre-connected and pre-filled.[10] There is no abdominal component in the ZSI 375, which along with its ready-to-implant configuration reduces the operating time.[11] Furthermore, because there is no abdominal component, surgical interventions in the retroperitoneal space are not required. Previous surgeries, such as radical prostatectomy, may lead to post-operative scarring and fibrosis in the retroperitoneal space. Thus, avoiding dissection of retroperitoneal tissues avoids risks of surgical complications.[12] [13] Another advantage of the ZSI 375 model is the possibility to increase or decrease the pressure inside the device after implantation to meet the desired continence rate and satisfaction of the patient. These adjustments particularly help to control continence in cases of post-implantation urethral atrophy or urinary retention (poor urine flow).[14] [15] Adjustment of the pressure can be done in an outpatient setting by adding or removing sterile saline solution via a syringe through the scrotum. By 2019, more than 4,500 ZSI 375 artificial urinary sphincters have been implanted worldwide. In addition to the devices mentioned above, new devices are being brought to market, such as the Rigicon ContiClassic and ContiReflex Artificial Urinary Sphincter systems. [16] [17]

In both models, sterile saline solution inside the system is used to generate pressure and compress the urethra (to prevent urine from leaking). The urethral cuff is deflated manually by pressing the control pump that is placed in the scrotum, allowing the patient to empty the bladder. The urethral cuff then re-inflates automatically to refill the urethral cuff and once again prevent urine from leaking.[18] [19]

The list includes AUS models available in 2023:

ProductCompanyCountry of originIntroduced inDesignPreconnected and prefilledPressure deliverPressure adjustable
AMS 800Boston Scientific (formerly American Medical Systems)United States of America19883-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorNo
ContiClassicRigicon Innovative Urological SolutionsUnited States of America20203-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorNo
ContiReflexRigicon Innovative Urological SolutionsUnited States of America20203-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorYes
ZSI 375Zephyr Surgical ImplantsSwitzerland20082-components: cuff, pump unitYesStainless steel spring inside the pump unit inserted in scrotumYes

Medical use

The intrinsic sphincter deficiency leading to stress incontinence is the most common indication for AUS implantation. The European Association of Urology recommends AUS implantation for moderate-to-severe stress incontinence in men.[20] Additionally, despite the novel treatment options (slings, urethral bulking injections, stem-cell therapy), AUS is considered to be the gold standard surgical management both for stress incontinence in men and for urinary incontinence developed as a complication of surgery, such as prostatectomy, cystectomy and TURP.

There are several case reports published in the literature of AUS implantation in children for secondary incontinence resulting from traumatic urethral injury.[21] [22]

There is limited data on AUS use in women, and not every product available in the market is designed for use in women.[23] The European Association of Urology provides limited recommendation on AUS use in women, stating that although cure is possible the risk of complication is high. Nonetheless, AUS has been used as a last resort for treating urinary incontinence in women due to congenital causes and secondary to neurological diseases.

Outcomes

Success rate

Numerous studies have been published regarding the outcomes of patients that have undergone artificial urinary sphincter implantation. The success rate, generally defined as achieving total (no pad use) or social continence (use of ≤1 pad/day) with the implanted device, ranges from 61% to 100% in the literature. Improvement in quality of life has also been considered as success even if more than 1 pad/day was needed. The success rate was reported at 78% with a 3-year follow-up,[24] and over 72% with 5 to 7 years of follow-up.[25] In a recent systematic review, the success rate was reported to be 79% with follow-up period ranging from 5 months to 16 years.[26] A comparative study among patients implanted with different models of artificial urinary sphincter and achieved social continence showed no difference between two groups in regards of urodynamic tests, such as flow rate, urethral pressure, etc.[27] A randomised controlled trial found that the artificial urinary sphincter was non-inferior to the male or synthetic sling with respect to improving incontinence. The male sling was more cost-effective.[28] [29]

Satisfaction

In different studies with a mean follow-up of more than 6 years,[30] [31] at least 73% of men with an implanted artificial urinary sphincter were satisfied or very satisfied with the device, and 10-23% reported dissatisfaction. At shorter periods of follow-up (2–4 years) the satisfaction rates achieved over 90%. In another study with mean follow-up of over 7 years, the overall satisfaction rate measured 3.9 on a scale from 0 to 5. The satisfaction rate in patients after radiotherapy does not seem to be unfavorably affected.[32] The initial satisfaction with the continence rate is reported to be improved by adjusting the pressure inside the implant with the ZSI 375 model.

Surveys of patients that underwent the procedure have found that over 90% would recommend the procedure to a friend or relative with the same problem, and over 90% would undergo the implantation again.[33] [34] Along with this, 14% of patients reported improvement in sexual activity.

The quality of life after AUS implantation has been shown to be significantly improved in numerous studies using various scaling tools. And the quality of life appears not to be adversely affected by reinterventions, providing that the device continues to function after the revision.

Reoperation

In the largest available series evaluating 1082 patients that underwent primary AUS placement, the 5-year device survival rate was 74% which is consistent with the reported outcomes in the literature, ranging from 59% to 79%.[35] Notably, in all series, over time some patients needed to undergo a repeat surgery for recurrent urinary incontinence or infection of the device. In a pooled analysis of the available studies the reintervention rate (for any cause) was roughly 26%. Significantly, some studies have demonstrated that surgeons who perform this procedure more frequently (high-volume surgeons) have improved outcomes compared to those who do them less frequently.[36] In fact, in this series the reoperative rates decreased by approximately 50% as surgeons reached their 200th case emphasizing the need for potential patients to seek high volume surgeons to improve their chance of success.

Complications

Possible risks arising from the implantation of the AUS include:

The overall reported complication rate in males is 37%.[37] The most common postoperative complications are:

Other less frequent complications are hematoma, urethral stenosis, urinary fistula.[38] Mechanical failures and non-mechanical complications may lead to surgical revision in 8-45% and 7-17% of cases, respectively. The overall device explantation rates in males is reported to be 16-20%.[39]

One of the causes of mechanical failure are the complications related to the balloon reservoir. It has been reported that 26% of men with an implanted AUS required reoperation at the 10-year follow-up, in order to regulate the pressure inside the device.

Follow-up

After discharge

Sexual intercourse should be avoided for the first 6 weeks after the procedure to allow the wound to heal properly.[40] Physical activities that put direct pressure on the wound, such as horseback and bike riding, should also be avoided for at least 6 weeks. Patients may be prescribed with a scrotal support to be worn for 1 week after the procedure.[41]

Ongoing care

To minimize the risk of damage to their AUS or urethra, it is vital that the patient informs their health care provider they have an AUS fitted before any urinary catheter placement, cystoscopy or any other medical intervention on the urinary tract.[42] Deactivating the device at nights may be recommended to patients, especially those who report being dry at night, to minimize the risks of urethral atrophy.[43]

See also

External links

Notes and References

  1. Bauer . Ricarda M. . Gozzi . Christian . Hübner . Wilhelm . Nitti . Victor W. . Novara . Giacomo . Peterson . Andrew . Sandhu . Jaspreet S. . Stief . Christian G. . Contemporary Management of Postprostatectomy Incontinence . European Urology . June 2011 . 59 . 6 . 985–996 . 10.1016/j.eururo.2011.03.020 . 21458914 .
  2. Cordon . Billy H . Singla . Nirmish . Singla . Ajay K . Artificial urinary sphincters for male stress urinary incontinence: current perspectives . Medical Devices: Evidence and Research . 4 July 2016 . 2016 . 9 . 175–183 . 10.2147/MDER.S93637 . 27445509 . 4938139 . free .
  3. Foley . Frederic E.B. . An Artificial Sphincter: A New Device and Operation for Control of Enuresis and Urinary Incontinence . Journal of Urology . October 1947 . 58 . 4 . 250–259 . 10.1016/S0022-5347(17)69552-1 . 20266239 . 5 February 2020.
  4. Scott . F. Brantley . Bradley . William E. . Timm . Gerald W. . Treatment of Urinary Incontinence By An Implantable Prosthetic Urinary Sphincter . Journal of Urology . July 1974 . 112 . 1 . 75–80 . 10.1016/S0022-5347(17)59647-0 . 4802066 . 5 February 2020.
  5. Yafi . Faysal A. . Powers . Mary K. . Zurawin . Jonathan . Hellstrom . Wayne J.G. . Contemporary Review of Artificial Urinary Sphincters for Male Stress Urinary Incontinence . Sexual Medicine Reviews . April 2016 . 4 . 2 . 157–166 . 10.1016/j.sxmr.2015.11.004 . 27872025.
  6. Suarez . Oscar A. . McCammon . Kurt A. . Kurt A. McCammon . June 2016 . The Artificial Urinary Sphincter in the Management of Incontinence . Urology . 92 . 14–19 . 10.1016/j.urology.2016.01.016 . 26845050 . 24 January 2020.
  7. Scott. F. B.. Bradley. W. E.. Timm. G. W.. 1974-07-01. Treatment of urinary incontinence by an implantable prosthetic urinary sphincter. The Journal of Urology. 112. 1. 75–80. 0022-5347. 4600662. 10.1016/s0022-5347(17)59647-0.
  8. Book: AMS 800™ Urinary Control System For Male Patients: Operating Room Manual . 2017 . Boston Scientific Corporation . Minnetonka, MN . 24 January 2020 . 24 February 2020 . https://web.archive.org/web/20200224001505/https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/92116964-01A_AMS_800_ORM_en_s.pdf . dead .
  9. Book: Zephyr Surgical Implants . ARTIFICIAL URINARY SPHINCTER ZSI 375 . November 2019 . Zephyr Surgical Implants . Geneva, Switzerland . Second . 19 January 2020.
  10. Ostrowski . Ireneusz . Golabek . Tomasz . Ciechan . Janusz . Śledź . Emil . Przydacz . Mikolaj . Dyś . Wojciech . Blewniewski . Mariusz . von Heyden . Burkhard . Pottek . Tobias . Neugart . Frank . Carrieri . Giuseppe . Selvaggio . Oscar . Iori . Francesco . Arjona . Manuel Fernández . Foley . Steve . Yang . Bob . Llorens . Christophe . Różanski . Waldemar . Chłosta . Piotr L. . Preliminary outcomes of the European multicentre experience with the ZSI 375 artificial urinary sphincter for treatment of stress urinary incontinence in men . Central European Journal of Urology . 2019 . 72 . 3 . 263–269 . 10.5173/ceju.2019.1920 . 31720028 . 6830485.
  11. Ostrowski . Ireneusz . Ciechan . Janusz . Sledz . Emil . Dys . Wojciech . Golabek . Tomasz . Chłosta . Piotr L. . Four-year follow-up on a ZSI 375 artificial urinary sphincter for male urinary incontinence from one urological centre in Poland . Central European Journal of Urology . 2018 . 71 . 3 . 320–325 . 10.5173/ceju.2018.1704 . 30386654 . 6202622.
  12. Sandhu . Jaspreet S. . Maschino . Alexandra C. . Vickers . Andrew J. . The Surgical Learning Curve for Artificial Urinary Sphincter Procedures Compared to Typical Surgeon Experience . European Urology . December 2011 . 60 . 6 . 1285–1290 . 10.1016/j.eururo.2011.05.048 . 21665357 . 3646622 . 27 January 2020.
  13. Staerman . Frederic . G-Llorens . Christophe . Leon . Priscilla . Leclerc . Yves . ZSI 375 artificial urinary sphincter for male urinary incontinence: a preliminary study . BJU International . April 2013 . 111 . 4b . E202–E206 . 10.1111/j.1464-410X.2012.11468.x . 22937774. 7963443 .
  14. Obando . Alejandro Carvajal . Gil . Federico Gavira . Martinez . Álvaro Gutiérrez . Molina . Luis Fernando Echeverry . Botero . Juan Carlos Castaño . Efficacy of the Artificial Urinary Sphincter ZSI 375 for Treatment of Post-Radical Prostatectomy Incontinence in Patients with Intrinsic Sphincter Deficiency: A Preliminary Study . European Medical Journal . 1 June 2017 . 2 . 2 . 22–26 . 10.33590/emj/10313028 . 258026552 . 27 January 2020. free .
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  16. Smith WJ, VanDyke ME, Venishetty N, Langford BT, Franzen BP, Morey AF . Surgical Management of Male Stress Incontinence: Techniques, Indications, and Pearls for Success . Res Rep Urol . 15 . 217–232 . 2023 . 37366389 . 10290851 . 10.2147/RRU.S395359 . free .
  17. Chung E, Liao L, Kim JH, Wang Z, Kitta T, Lin AT, Lee KS, Ye L, Chu P, Kaiho Y, Takei M, Jiang H, Lee J, Masuda H, Tse V . The Asia-Pacific AMS800 artificial urinary sphincter consensus statement . Int J Urol . 30 . 2 . 128–138 . February 2023 . 36375037 . 10100264 . 10.1111/iju.15083 .
  18. Ioannis. Vakalopoulos . Spyridon. Kampantais . Leonidas. Laskaridis . Vasileios. Chachopoulos . Michail. Koptsis . Chrysovalantis. Toutziaris . New Artificial Urinary Sphincter Devices in the Treatment of Male Iatrogenic Incontinence . Advances in Urology . 2012 . 1–6 . 10.1155/2012/439372 . 22567002 . 2012 . 3332164. free .
  19. Chung . Eric . Contemporary surgical devices for male stress urinary incontinence: a review of technological advances in current continence surgery . Translational Andrology and Urology . July 2017 . 6 . Supplement 2 . S112–S121 . 10.21037/tau.2017.04.12 . 28791230 . 5522789 . free .
  20. Book: Burkhard . F.C. . Bosch . J.L.H.R. . Cruz . F. . Lemack . G.E. . Nambiar . A.K. . Thiruchelvam . N. . Tubaro . A. . EAU Guidelines on Urinary Incontinence in Adults . 2018 . European Association of Urology . Arnhem, The Netherlands . 978-94-92671-01-1 . 24 January 2020 . 2020-02-08 . https://web.archive.org/web/20200208090241/https://uroweb.org/wp-content/uploads/EAU-Guidelines-on-Urinary-Incontinence-2018-large-text.pdf . dead .
  21. Routh . Jonathan C. . Husmann . Douglas A. . Long-term continence outcomes after immediate repair of pediatric bladder neck lacerations extending into the urethra . The Journal of Urology . 1 October 2007 . 178 . 4S . 1816–1818 . 10.1016/j.juro.2007.05.094 . 17707005.
  22. Kandpal . DK . Rawat . SK . Kanwar . S . Baruha . A . Chowdhary . SK . Single piece artificial urinary sphincter for secondary incontinence following successful repair of post traumatic urethral injury . Journal of Indian Association of Pediatric Surgeons . 2013 . 18 . 4 . 152–154 . 10.4103/0971-9261.121120 . 24347870. 3853858 . free .
  23. Islah . MAR . Cho . Sung Yong . Son . Hwancheol . The Current Role of the Artificial Urinary Sphincter in Male and Female Urinary Incontinence . The World Journal of Men's Health . April 2013 . 31 . 1 . 21–30 . 10.5534/wjmh.2013.31.1.21 . 23658862 . 3640149.
  24. Ostrowski . Ireneusz . Blewniewski . Mariusz . Neugart . Frank . von Heyden . Burkhard . Selvaggio . Oscar . Iori . Francesco . Foley . Steeve . Fernández Arjona . Manuel . Carvajal Obando . Alejandro . Pottek . Tobias . Multicentre Experience with ZSI 375 Artificial Urinary Sphincter for the Treatment of Stress Urinary Incontinence in Men . Urologia Journal . 29 May 2017 . 84 . 3 . 148–152 . 10.5301/uj.5000246 . 28574143. free .
  25. Llorens . Christophe . Pottek . Tobias . Urinary Artificial Sphincter ZSI 375 for Treatment of Stress Urinary Incontinence in Men: 5 and 7 Years Follow-Up Report . Urologia Journal . 18 May 2017 . 84 . 4 . 263–266 . 10.5301/uj.5000243 . 28525665. free .
  26. Van der Aa . Frank . Drake . Marcus J. . Kasyan . George R. . Petrolekas . Andreas . Cornu . Jean-Nicolas . The Artificial Urinary Sphincter After a Quarter of a Century: A Critical Systematic Review of Its Use in Male Non-neurogenic Incontinence . European Urology . April 2013 . 63 . 4 . 681–689 . 10.1016/j.eururo.2012.11.034 . 23219375 . 25 January 2020.
  27. Ripert . Thomas . Pierrevelcin . Jean . Comparative study of urodynamic tests after AMS 800 and ZSI 375 insertion . Urologia Journal . February 2018 . 85 . 1 . 15–18 . 10.5301/uj.5000271 . 28967063. free .
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  32. Herschorn . Sender . The artificial urinary sphincter is the treatment of choice for post–radical prostatectomy incontinence . Canadian Urological Association Journal . 17 April 2013 . 2 . 5 . 536–9 . 10.5489/cuaj.924 . 18953453 . 2572249.
  33. Viers. Boyd R.. Linder. Brian J.. Rivera. Marcelino E.. Rangel. Laureano J.. Ziegelmann. Matthew J.. Elliott. Daniel S.. Long-Term Quality of Life and Functional Outcomes among Primary and Secondary Artificial Urinary Sphincter Implantations in Men with Stress Urinary Incontinence. The Journal of Urology. 196. 3. 838–843. 10.1016/j.juro.2016.03.076. 26997310. 2016.
  34. Litwiller . Scott E. . Kim . Kap B. . Fone . Patricia D. . deVere White . Ralph W. . Stone . Anthony R. . Post-Prostatectomy incontinence and the Artificial Urinary Sphincter: A Long-Term Study of Patient Satisfaction and Criteria for Success . Journal of Urology . December 1996 . 156 . 6 . 1975–1980 . 10.1016/S0022-5347(01)65408-9 . 8911369 . 2 February 2020.
  35. Linder. Brian J.. Rivera. Marcelino E.. Ziegelmann. Matthew J.. Elliott. Daniel S.. Long-term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic. Urology. 86. 3. 602–607. 10.1016/j.urology.2015.05.029. 26135815. 2015.
  36. Sandhu. Jaspreet S.. Maschino. Alexandra C.. Vickers. Andrew J.. The Surgical Learning Curve for Artificial Urinary Sphincter Procedures Compared to Typical Surgeon Experience. European Urology. 60. 6. 1285–1290. 10.1016/j.eururo.2011.05.048. 3646622. 21665357. 2011.
  37. Hussain . Mahreen . Greenwell . Tamsin J. . Venn . Suzie N. . Mundy . Anthony R. . The current role of the artificial urinary sphincter for the treatment of urinary incontinence . Journal of Urology . 1 August 2005 . 174 . 2 . 418–424 . 10.1097/01.ju.0000165345.11199.98 . 23658862. 3640149 .
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  40. Web site: Urinary Sphincter Replacement (Discharge Care) - What You Need to Know . Drugs.com . 25 March 2020 . en.
  41. Web site: About Your Artificial Urinary Sphincter Memorial Sloan Kettering Cancer Center . www.mskcc.org . Memorial Sloan Kettering Cancer Center . 25 March 2020 . en.
  42. Agarwal. Deepak K. Linder. Brian J. Elliott. Daniel S. 2016. Artificial urinary sphincter urethral erosions: Temporal patterns, management, and incidence of preventable erosions. Indian Journal of Urology. 33. 1. 26–29. 10.4103/0970-1591.195758. 28197026. 5264188 . free .
  43. Elliott . Daniel S . Barrett . David M . Gohma . Mohamed . Boone . Timothy B . Does nocturnal deactivation of the artificial urinary sphincter lessen the risk of urethral atrophy? . Urology . June 2001 . 57 . 6 . 1051–1054 . 10.1016/s0090-4295(01)00963-3 . 11377302 .

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