Artificial urinary sphincter

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Artificial urinary sphincter
Blausen 0059 ArtificialUrinarySphincter.png
3D Model of AMS 800
Artificial Urinary Sphincter ZSI 375.png
3D Model of ZSI 375
Other namesInflatable artificial sphincter
Specialty Urology
ICD-10-PCS 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.

Contents

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

Artificial urinary sphincters (left to right: AMS 800 and ZSI 375) Artificial urinary sphincters.jpg
Artificial urinary sphincters (left to right: AMS 800 and ZSI 375)

Frederic Foley was the first to describe an externally worn artificial urinary sphincter to treat urinary incontinence, published in 1947. [5] In 1972, F. Brantley Scott and colleagues from Baylor College of Medicine designed the first precursor of contemporary artificial urinary sphincter. [6] [7] The first AUS model on the market was the AMS 800 (Boston Scientific, Marlborough, MA), developed 50 years ago. [8] [9] 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. [10]

Another AUS model is the ZSI 375 (Zephyr Surgical Implants, Geneva, Switzerland), introduced in 2008. [11] 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. [1] [12] There is no abdominal component in the ZSI 375, which along with its ready-to-implant configuration reduces the operating time. [13] 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. [14] [15] 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). [16] [17] [13] Adjustment of the pressure can be done in an outpatient setting by adding or removing sterile saline solution via a syringe through the scrotum. [12] By 2019, more than 4,500 ZSI 375 artificial urinary sphincters have been implanted worldwide. [11] 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. [18] [19]

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. [20] [21]

The list includes AUS models available in 2023:

ProductCompanyCountry of originIntroduced inDesignPreconnected and prefilledPressure deliverPressure adjustable
AMS 800 Boston Scientific (formerly American Medical Systems) United States of America 19883-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorNo
ContiClassicRigicon Innovative Urological Solutions United States of America 20203-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorNo
ContiReflexRigicon Innovative Urological Solutions United States of America 20203-components: cuff, pump, balloon reservoirNoFlexible reservoir inserted in pelvic floorYes
ZSI 375 Zephyr Surgical Implants Switzerland 20082-components: cuff, pump unitYesStainless steel spring inside the pump unit inserted in scrotumYes

Medical use

Implanted AMS 800.jpg
Implanted ZSI 375.jpg
Diagrams and videos of implanted artificial urinary sphincters in operation (top to bottom: AMS 800 and ZSI 375)
Correcting post-implantation incontinence with pressure adjustment in ZSI 375-implanted patient ZSI 375 Pressure Adjustment.gif
Correcting post-implantation incontinence with pressure adjustment in ZSI 375-implanted patient

The intrinsic sphincter deficiency leading to stress incontinence is the most common indication for AUS implantation. [9] The European Association of Urology recommends AUS implantation for moderate-to-severe stress incontinence in men. [22] 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. [8] [4] [3]

There are several case reports published in the literature of AUS implantation in children for secondary incontinence resulting from traumatic urethral injury. [23] [24]

There is limited data on AUS use in women, and not every product available in the market is designed for use in women. [25] [26] 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. [22] Nonetheless, AUS has been used as a last resort for treating urinary incontinence in women due to congenital causes and secondary to neurological diseases. [25]

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. [4] 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, [27] and over 72% with 5 to 7 years of follow-up. [28] In a recent systematic review, the success rate was reported to be 79% with follow-up period ranging from 5 months to 16 years. [29] 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. [2] 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. [30] [31]

Satisfaction

In different studies with a mean follow-up of more than 6 years, [32] [33] 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%. [29] [32] [4] 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. [32] The satisfaction rate in patients after radiotherapy does not seem to be unfavorably affected. [34] The initial satisfaction with the continence rate is reported to be improved by adjusting the pressure inside the implant with the ZSI 375 model. [26]

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. [35] [36] Along with this, 14% of patients reported improvement in sexual activity. [36]

The quality of life after AUS implantation has been shown to be significantly improved in numerous studies using various scaling tools. [29] [7] And the quality of life appears not to be adversely affected by reinterventions, providing that the device continues to function after the revision.[ citation needed ]

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%. [37] 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%. [29] 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. [26] 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. [26]

Complications

Possible risks arising from the implantation of the AUS include: [1]

The overall reported complication rate in males is 37%. [38] The most common postoperative complications are:

Other less frequent complications are hematoma, urethral stenosis, urinary fistula. [39] 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%. [40]

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. [41] 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. [42]

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. [43] 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. [44] [41]

See also

Related Research Articles

<span class="mw-page-title-main">Urethra</span> Tube that connects the urinary bladder to the external urethral orifice

The urethra is a tube that connects the urinary bladder to the urinary meatus for the removal of urine from the body of both females and males. In human females and other primates, the urethra connects to the urinary meatus above the vagina, whereas in marsupials, the female's urethra empties into the urogenital sinus.

<span class="mw-page-title-main">Urinary incontinence</span> Uncontrolled leakage of urine

Urinary incontinence (UI), also known as involuntary urination, is any uncontrolled leakage of urine. It is a common and distressing problem, which may have a large impact on quality of life. It has been identified as an important issue in geriatric health care. The term enuresis is often used to refer to urinary incontinence primarily in children, such as nocturnal enuresis. UI is an example of a stigmatized medical condition, which creates barriers to successful management and makes the problem worse. People may be too embarrassed to seek medical help, and attempt to self-manage the symptom in secrecy from others.

<span class="mw-page-title-main">Onuf's nucleus</span> Group of neurons

Onuf's nucleus is a distinct group of neurons located in the ventral part of the anterior horn of the sacral region of the human spinal cord involved in the maintenance of micturition and defecatory continence, as well as muscular contraction during orgasm. It contains motor neurons, and is the origin of the pudendal nerve. The sacral region of the spinal cord is the fourth segment of vertebrae in the spinal cord which consists of the vertebrae 26-30. While working in New York City in 1899, Bronislaw Onuf-Onufrowicz discovered this group of unique cells and originally identified it as “Group X.” “Group X” was considered distinct by Onufrowicz because the cells were different in size from the surrounding neurons in the anterolateral group, suggesting that they were independent.

<span class="mw-page-title-main">Transurethral resection of the prostate</span> Surgical procedure to perform a prostatectomy

Transurethral resection of the prostate is a urological operation. It is used to treat benign prostatic hyperplasia (BPH). As the name indicates, it is performed by visualising the prostate through the urethra and removing tissue by electrocautery or sharp dissection. It has been the standard treatment for BPH for many years, but recently alternative, minimally invasive techniques have become available. This procedure is done with spinal or general anaesthetic. A triple lumen catheter is inserted through the urethra to irrigate and drain the bladder after the surgical procedure is complete. The outcome is considered excellent for 80–90% of BPH patients. The procedure carries minimal risk for erectile dysfunction, moderate risk for bleeding, and a large risk for retrograde ejaculation.

<span class="mw-page-title-main">Prostatectomy</span> Surgical removal of all or part of the prostate gland

Prostatectomy is the surgical removal of all or part of the prostate gland. This operation is done for benign conditions that cause urinary retention, as well as for prostate cancer and for other cancers of the pelvis.

<span class="mw-page-title-main">Radical retropubic prostatectomy</span>

Radical retropubic prostatectomy is a surgical procedure in which the prostate gland is removed through an incision in the abdomen. It is most often used to treat individuals who have early prostate cancer. Radical retropubic prostatectomy can be performed under general, spinal, or epidural anesthesia and requires blood transfusion less than one-fifth of the time. Radical retropubic prostatectomy is associated with complications such as urinary incontinence and impotence, but these outcomes are related to a combination of individual patient anatomy, surgical technique, and the experience and skill of the surgeon.

<span class="mw-page-title-main">Stress incontinence</span> Form of urinary incontinence from an inadequate closure of the bladder

Stress incontinence, also known as stress urinary incontinence (SUI) or effort incontinence is a form of urinary incontinence. It is due to inadequate closure of the bladder outlet by the urethral sphincter.

Neurogenic bladder dysfunction, or neurogenic bladder, refers to urinary bladder problems due to disease or injury of the central nervous system or peripheral nerves involved in the control of urination. There are multiple types of neurogenic bladder depending on the underlying cause and the symptoms. Symptoms include overactive bladder, urinary urgency, frequency, incontinence or difficulty passing urine. A range of diseases or conditions can cause neurogenic bladder including spinal cord injury, multiple sclerosis, stroke, brain injury, spina bifida, peripheral nerve damage, Parkinson's disease, or other neurodegenerative diseases. Neurogenic bladder can be diagnosed through a history and physical as well as imaging and more specialized testing. Treatment depends on underlying disease as well as symptoms and can be managed with behavioral changes, medications, surgeries, or other procedures. The symptoms of neurogenic bladder, especially incontinence, can have a significant impact on quality of life.

<span class="mw-page-title-main">Retropubic space</span>

Retropubic space is a potential avascular space located between the pubic symphysis and the urinary bladder. The retropubic space is a preperitoneal space, located behind the transversalis fascia and in front of peritoneum.

<span class="mw-page-title-main">Urethral sphincters</span> Muscles keeping urine in the bladder

The urethral sphincters are two muscles used to control the exit of urine in the urinary bladder through the urethra. The two muscles are either the male or female external urethral sphincter and the internal urethral sphincter. When either of these muscles contracts, the urethra is sealed shut.

<span class="mw-page-title-main">Internal urethral sphincter</span> Urethral sphincter muscle which constricts the internal urethral orifice

The internal urethral sphincter is a urethral sphincter muscle which constricts the internal urethral orifice. It is located at the junction of the urethra with the urinary bladder and is continuous with the detrusor muscle, but anatomically and functionally fully independent from it. It is composed of smooth muscle, so it is under the control of the autonomic nervous system, specifically the sympathetic nervous system.

Urethroplasty is the surgical repair of an injury or defect within the walls of the urethra. Trauma, iatrogenic injury and infections are the most common causes of urethral injury/defect requiring repair. Urethroplasty is regarded as the gold standard treatment for urethral strictures and offers better outcomes in terms of recurrence rates than dilatations and urethrotomies. It is probably the only useful modality of treatment for long and complex strictures though recurrence rates are higher for this difficult treatment group.

Sacral nerve stimulation, also termed sacral neuromodulation, is a type of medical electrical stimulation therapy.

<span class="mw-page-title-main">Prostate brachytherapy</span> Radiation therapy technique for the treatment of cancer

Brachytherapy is a type of radiotherapy, or radiation treatment, offered to certain cancer patients. There are two types of brachytherapy – high dose-rate (HDR) and low dose-rate (LDR). LDR brachytherapy is the one most commonly used to treat prostate cancer. It may be referred to as 'seed implantation' or it may be called 'pinhole surgery'.

Treatment for prostate cancer may involve active surveillance, surgery, radiation therapy – including brachytherapy and external-beam radiation therapy, proton therapy, high-intensity focused ultrasound (HIFU), cryosurgery, hormonal therapy, chemotherapy, or some combination. Treatments also extend to survivorship based interventions. These interventions are focused on five domains including: physical symptoms, psychological symptoms, surveillance, health promotion and care coordination. However, a published review has found only high levels of evidence for interventions that target physical and psychological symptom management and health promotion, with no reviews of interventions for either care coordination or surveillance. The favored treatment option depends on the stage of the disease, the Gleason score, and the PSA level. Other important factors include the man's age, his general health, and his feelings about potential treatments and their possible side-effects. Because all treatments can have significant side-effects, such as erectile dysfunction and urinary incontinence, treatment discussions often focus on balancing the goals of therapy with the risks of lifestyle alterations.

In fecal incontinence (FI), surgery may be carried out if conservative measures alone are not sufficient to control symptoms. There are many surgical options described for FI, and they can be considered in 4 general groups.

Urethral hypermobility is a condition of excessive movement of the female urethra due to a weakened urogenital diaphragm. It describes the instability of the urethra in relation to the pelvic floor muscles. A weakened pelvic floor muscle fails to adequately close the urethra and hence can cause stress urinary incontinence. This condition may be diagnosed by primary care providers or urologists. Treatment may include pelvic floor muscle exercises, surgery, or minimally invasive procedures.

<span class="mw-page-title-main">Surgery for benign prostatic hyperplasia</span> Type of surgery

If medical treatment is not effective, surgery may need to be performed for benign prostatic hyperplasia.

<span class="mw-page-title-main">Zephyr Surgical Implants</span>

Zephyr Surgical Implants (ZSI) is a Swiss-based medical device manufacturer that produces and distributes artificial urinary sphincters and penile implants worldwide. ZSI products are used in the management of moderate-to-severe urinary incontinence in men, erectile dysfunction, Peyronie's disease, penis enlargement, and female-to-male gender reassignment surgery.

<span class="mw-page-title-main">Penis clamp</span> A device that treats urinary incontinence

Penis clamp is an external penis compression device that treats male urinary incontinence. Incontinence clamps for men are applied to compress the urethra to compensate for the malfunctioning of the natural urinary sphincter, preventing leakage from the bladder with minimal restriction of blood flow.

References

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  5. ↑ Foley, Frederic E.B. (October 1947). "An Artificial Sphincter: A New Device and Operation for Control of Enuresis and Urinary Incontinence". Journal of Urology. 58 (4): 250–259. doi:10.1016/S0022-5347(17)69552-1. PMID   20266239 . Retrieved 5 February 2020.
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  14. ↑ Sandhu, Jaspreet S.; Maschino, Alexandra C.; Vickers, Andrew J. (December 2011). "The Surgical Learning Curve for Artificial Urinary Sphincter Procedures Compared to Typical Surgeon Experience". European Urology. 60 (6): 1285–1290. doi:10.1016/j.eururo.2011.05.048. PMC   3646622 . PMID   21665357 . Retrieved 27 January 2020.
  15. ↑ Staerman, Frederic; G-Llorens, Christophe; Leon, Priscilla; Leclerc, Yves (April 2013). "ZSI 375 artificial urinary sphincter for male urinary incontinence: a preliminary study". BJU International. 111 (4b): E202–E206. doi:10.1111/j.1464-410X.2012.11468.x. PMID   22937774. S2CID   7963443.
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  26. 1 2 3 4 Sandhu, Jaspreet S.; Maschino, Alexandra C.; Vickers, Andrew J. (2011). "The Surgical Learning Curve for Artificial Urinary Sphincter Procedures Compared to Typical Surgeon Experience". European Urology. 60 (6): 1285–1290. doi:10.1016/j.eururo.2011.05.048. PMC   3646622 . PMID   21665357.
  27. ↑ Ostrowski, Ireneusz; Blewniewski, Mariusz; Neugart, Frank; von Heyden, Burkhard; Selvaggio, Oscar; Iori, Francesco; Foley, Steeve; Fernández Arjona, Manuel; Carvajal Obando, Alejandro; Pottek, Tobias (29 May 2017). "Multicentre Experience with ZSI 375 Artificial Urinary Sphincter for the Treatment of Stress Urinary Incontinence in Men". Urologia Journal. 84 (3): 148–152. doi: 10.5301/uj.5000246 . PMID   28574143.
  28. ↑ Llorens, Christophe; Pottek, Tobias (18 May 2017). "Urinary Artificial Sphincter ZSI 375 for Treatment of Stress Urinary Incontinence in Men: 5 and 7 Years Follow-Up Report". Urologia Journal. 84 (4): 263–266. doi: 10.5301/uj.5000243 . PMID   28525665.
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  33. ↑ Chung, Eric (17 June 2014). "A state-of-the-art review on the evolution of urinary sphincter devices for the treatment of post-prostatectomy urinary incontinence: Past, present and future innovations". Journal of Medical Engineering & Technology. 38 (6): 328–332. doi:10.3109/03091902.2014.899400. PMID   24936961. S2CID   207462001.
  34. ↑ Herschorn, Sender (17 April 2013). "The artificial urinary sphincter is the treatment of choice for post–radical prostatectomy incontinence". Canadian Urological Association Journal. 2 (5): 536–9. doi:10.5489/cuaj.924. PMC   2572249 . PMID   18953453.
  35. ↑ Viers, Boyd R.; Linder, Brian J.; Rivera, Marcelino E.; Rangel, Laureano J.; Ziegelmann, Matthew J.; Elliott, Daniel S. (2016). "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. doi:10.1016/j.juro.2016.03.076. PMID   26997310.
  36. 1 2 Litwiller, Scott E.; Kim, Kap B.; Fone, Patricia D.; deVere White, Ralph W.; Stone, Anthony R. (December 1996). "Post-Prostatectomy incontinence and the Artificial Urinary Sphincter: A Long-Term Study of Patient Satisfaction and Criteria for Success". Journal of Urology. 156 (6): 1975–1980. doi:10.1016/S0022-5347(01)65408-9. PMID   8911369 . Retrieved 2 February 2020.
  37. ↑ Linder, Brian J.; Rivera, Marcelino E.; Ziegelmann, Matthew J.; Elliott, Daniel S. (2015). "Long-term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic". Urology. 86 (3): 602–607. doi:10.1016/j.urology.2015.05.029. PMID   26135815.
  38. ↑ Hussain, Mahreen; Greenwell, Tamsin J.; Venn, Suzie N.; Mundy, Anthony R. (1 August 2005). "The current role of the artificial urinary sphincter for the treatment of urinary incontinence". Journal of Urology. 174 (2): 418–424. doi:10.1097/01.ju.0000165345.11199.98. PMC   3640149 . PMID   23658862.
  39. ↑ Islah, MAR; Cho, Sung Yong; Son, Hwancheol (April 2013). "The Current Role of the Artificial Urinary Sphincter in Male and Female Urinary Incontinence". The World Journal of Men's Health. 31 (2): 21–30. doi: 10.5534/wjmh.2013.31.1.21 . PMC   3640149 . PMID   23658862.
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