Male Artificial Urinary Sphincter Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Type (AUS with a balloon reservoir (3-component), AUS with a spring (2-component)), By End-user (Hospitals, Clinics & Other Healthcare Centers, Academic & Research Centers), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 511.77 Million
CAGR (2026-2031)	4.67%
Fastest Growing Segment	Hospitals
Largest Market	North America
Market Size (2031)	USD 672.99 Million

Market Overview

The Global Male Artificial Urinary Sphincter Market will grow from USD 511.77 Million in 2025 to USD 672.99 Million by 2031 at a 4.67% CAGR. The Global Male Artificial Urinary Sphincter Market defines the segment for implantable medical devices designed to treat moderate to severe stress urinary incontinence by mimicking the natural function of the healthy urinary sphincter. This market is primarily propelled by the rising prevalence of post-prostatectomy incontinence resulting from prostate cancer surgeries and an expanding geriatric population prone to urological dysfunction. These drivers underscore the critical need for effective long-term continence solutions and distinctively support growth beyond transient industry trends.

Despite the clinical benefits, the market faces a significant impediment due to the high cost of the device and the risks associated with surgical revision. Mechanical failure and urethral erosion remain substantial concerns that can deter patient adoption and limit widespread accessibility. According to the American Urological Association, in 2024, updated guidelines indicated that 14% to 25% of men who underwent prostatectomy reported bothersome leakage. This statistic highlights the persistent clinical burden that necessitates such devices yet also frames the high stakes for device reliability and affordability in this sensitive therapeutic area.

Key Market Drivers

The increasing incidence of prostate cancer acts as a primary catalyst for the Global Male Artificial Urinary Sphincter Market, directly expanding the patient pool requiring continence restoration. As radical prostatectomy remains a definitive treatment for malignancies, the resulting compromise of the urethral sphincter necessitates effective long-term implantable solutions. This demand is quantified by the substantial volume of new diagnoses; according to the American Cancer Society, September 2025, in the 'Prostate Cancer Statistics, 2025' report, an estimated 313,780 new cases of prostate cancer were projected to be diagnosed in the United States. Such high incidence rates underscore the critical need for post-surgical management devices. Furthermore, the market trajectory is reinforced by intensifying epidemiological trends. According to the American Cancer Society, in 2025, the incidence rate of prostate cancer was reported to have increased by 3% annually from 2014 through 2021, signaling a growing clinical burden that sustains the demand for artificial sphincters.

Technological advancements in artificial sphincter device design are further propelling market expansion by addressing historical limitations related to mechanical reliability and surgical revision. Manufacturers are introducing next-generation devices with enhanced materials and user-friendly pump components to mitigate risks such as urethral atrophy and device failure, thereby encouraging higher adoption rates among surgeons and patients. These product innovations have translated into tangible commercial success for key industry players. For instance, according to Boston Scientific, October 2025, in the 'Q3 2025 Earnings' report, the MedSurg segment, which houses the company's urology portfolio, achieved a reported sales growth of 16.4% compared to the prior year. This robust financial performance validates the market's responsiveness to sophisticated engineering, highlighting a shift towards modern, reliable solutions for severe urinary incontinence.

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Key Market Challenges

The susceptibility of artificial urinary sphincters to mechanical failure and the consequent need for surgical revision represents a formidable barrier to the Global Male Artificial Urinary Sphincter Market. While these devices provide a critical solution for severe incontinence, the inherent risks of device malfunction, urethral erosion, and infection create substantial apprehension among patients and healthcare providers. This fear of repeat invasive procedures often outweighs the potential benefits, causing many eligible candidates to opt for conservative management strategies. Consequently, the uncertainty regarding long-term reliability significantly dampens patient confidence and limits the addressable market size.

Furthermore, the high rate of re-operation imposes a severe economic and clinical burden that restricts broader market expansion. The associated costs of revision surgery strain healthcare budgets and reduce the perceived cost-effectiveness of the therapy. This reliability issue is underscored by recent clinical data. According to the American Urological Association, in 2025, a large-scale study indicated that the probability of surgical reintervention for artificial urinary sphincter implants reached 29% within just two years of the initial procedure. Such statistics highlight the persistent durability challenges that deter stakeholders from fully embracing this therapeutic option.

Key Market Trends

The Integration of Smart and Electronic AUS Systems is transforming the market by replacing traditional mechanical pumps with automated, patient-specific control mechanisms. These devices utilize embedded sensors and software algorithms to adjust cuff pressure in real-time, reducing the risk of urethral damage while ensuring effective continence. This shift toward active implantable devices is supported by substantial financial confidence from industry stakeholders, indicating a move beyond manual hydraulic systems. According to UroMems, June 2024, in the 'UroMems Raises Record $47 million in Series C Financing' press release, the company secured $47 million to fund pivotal clinical trials for its UroActive System, the first smart automated artificial urinary sphincter.

The Development of Adjustable Pressure-Regulating Mechanisms is addressing the challenge of mechanical stress on the urethra through advanced hydraulic engineering. Innovation in this area focuses on dynamic pressure balloons capable of accommodating intra-abdominal pressure spikes, such as those caused by coughing, without maintaining constantly high static pressure that contributes to tissue atrophy. These design enhancements are demonstrating high reliability in recent clinical updates, offering surgeons viable alternatives to legacy designs. According to Rigicon, May 2024, in the 'Rigicon Announces Groundbreaking Advances in Prosthetic Urology with ContiReflex and Testi10 Testicular Prosthesis' press release, early study findings for the ContiReflex system indicated a 98% device survival rate at 18 months among the implanted patients.

Segmental Insights

The Hospitals segment is recognized as the fastest growing category in the Global Male Artificial Urinary Sphincter Market due to the increasing preference for performing complex implantation procedures within established medical institutions. This expansion is largely driven by the rising incidence of stress urinary incontinence following prostate surgeries, which requires the advanced surgical capabilities and sterile environments exclusively found in hospitals. Additionally, the availability of comprehensive post-operative monitoring and favorable reimbursement schemes for inpatient care significantly contributes to the sustained demand for hospital-based treatments.

Regional Insights

North America leads the Global Male Artificial Urinary Sphincter Market, primarily driven by the rising prevalence of urinary incontinence resulting from prostate cancer treatments and an aging population. The region benefits from a robust healthcare infrastructure that facilitates the early adoption of approved medical devices. Furthermore, the presence of major market players, such as Boston Scientific, alongside favorable reimbursement policies, significantly enhances product accessibility. Regulatory bodies like the U.S. Food and Drug Administration (FDA) play a critical role by ensuring device safety and efficacy through stringent approval processes, thereby fostering market confidence and growth.

Recent Developments

• In June 2024, UroMems announced the completion of a $47 million Series C financing round to support the ongoing development of its UroActive System. The company stated that the proceeds would be primarily dedicated to funding pivotal clinical trials for the device, which is described as the first smart automated artificial urinary sphincter. This significant investment followed the successful completion of first-in-human feasibility studies, where the device met its primary safety and performance endpoints. UroMems aims to use this technology to provide a personalized and adaptive treatment option for patients suffering from stress urinary incontinence.
• In May 2024, Rigicon released clinical study results confirming the early safety and efficacy of its ContiReflex Artificial Urinary Sphincter. The data, which was presented at the American Urological Association Annual Meeting, demonstrated a 98% device survival rate at 18 months post-implantation in patients treated for male stress urinary incontinence. The ContiReflex system features a unique stress relief balloon designed to automatically adjust cuff pressure during sudden increases in intra-abdominal pressure. The company highlighted these findings as evidence that the device offers a safe and effective alternative to existing market standards.
• In March 2024, Affluent Medical announced the successful first-in-human implantation of its Artus artificial urinary sphincter in a male patient. The procedure was performed in the Czech Republic as part of the company’s European 'Dry' pilot study. Affluent Medical described the Artus device as the first artificial sphincter that can be activated by the patient via a remote control, designed to treat moderate to severe urinary incontinence. This clinical milestone was a critical step in validating the device's safety and ease of use before the company transitions to a pivotal study required for market approval.
• In January 2024, Boston Scientific announced a definitive agreement to acquire Axonics, Inc. for approximately $3.7 billion. While Axonics is primarily specialized in sacral neuromodulation for bladder dysfunction, the acquisition was strategically positioned to expand Boston Scientific’s market-leading urology portfolio, which includes the widely used AMS 800 artificial urinary sphincter. The company indicated that this transaction would broaden its comprehensive suite of solutions for urinary incontinence, allowing for greater commercial synergies and reinforcing its commitment to leadership in the pelvic health and incontinence treatment sectors.

Key Market Players

• Boston Scientific Corporation
• Zephyr Surgical Implants
• Affluent Medical
• UroMems (URO MEMS)
• Rigicon
• ProMinent GmbH
• Coloplast A/S
• Medtronic plc
• Stryker Corporation
• Silimed

By Type	By End-user	By Region
AUS with a balloon reservoir (3-component) AUS with a spring (2-component)	Hospitals Clinics & Other Healthcare Centers Academic & Research Centers	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Male Artificial Urinary Sphincter Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Male Artificial Urinary Sphincter Market, By Type:

• AUS with a balloon reservoir (3-component)
• AUS with a spring (2-component)

• Male Artificial Urinary Sphincter Market, By End-user:

• Hospitals
• Clinics & Other Healthcare Centers
• Academic & Research Centers

• Male Artificial Urinary Sphincter Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE