Female Stress Urinary Incontinence Treatment Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Urethral Slings, Catheters, Vaginal Pessaries, and Others), By End-user (Hospitals & Ambulatory Surgical Centers (ASCs), Specialty Clinics, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 783.03 Million
CAGR (2026-2031)	7.51%
Fastest Growing Segment	Urethral Slings
Largest Market	North America
Market Size (2031)	USD 1209.13 Million

Market Overview

The Global Female Stress Urinary Incontinence (SUI) Devices Market will grow from USD 783.03 Million in 2025 to USD 1209.13 Million by 2031 at a 7.51% CAGR. Female stress urinary incontinence devices, comprising urethral bulking agents, midurethral slings, and vaginal pessaries, are specialized medical products designed to restore continence by supporting the bladder neck or enhancing urethral closure during physical exertion. The market for these devices is fundamentally driven by demographic shifts, specifically the expanding aging female population and the rising incidence of obesity, which are primary risk factors for pelvic floor weakness. Furthermore, the growing preference for minimally invasive surgical interventions and increased patient education regarding effective management strategies are accelerating the adoption of these therapeutic solutions.

This robust demand is underscored by significant prevalence rates that highlight the urgent clinical need for effective interventions. According to 'AUANews', in '2025', 'stress urinary incontinence is the most common type of urinary incontinence with a prevalence of over 40% in females who actively participate in physical activities'. Despite these positive growth indicators, the market faces a substantial impediment regarding stringent regulatory requirements and ongoing litigation related to the safety of transvaginal mesh implants, which continues to impact surgeon confidence and patient willingness to undergo mesh based procedures.

Key Market Drivers

The rising prevalence of female stress urinary incontinence (SUI) serves as a foundational driver for the devices market, creating an expanding clinical demand globally. This demographic pressure, intensified by an aging female population and lifestyle factors, necessitates a broader range of therapeutic interventions. The sheer scale of this condition forces healthcare providers to prioritize scalable solutions, ranging from urethral bulking agents to advanced surgical implants. Highlighting this extensive burden, according to UroMems, June 2024, in the 'UroMems Raises Record $47 million in Series C Financing' press release, stress urinary incontinence affects an estimated 40 million Americans and 90 million Europeans. This substantial patient base underscores the critical need for effective management strategies, further supported by workforce-specific data; according to the International Continence Society, in 2024, the prevalence of urinary incontinence in working-age professional women is greater than 25%, indicating that the condition is pervasive across active populations and not limited solely to the geriatric demographic.

Simultaneously, the technological integration of smart and wearable devices is revolutionizing the market by facilitating non-invasive, home-based therapeutic options. As patients increasingly seek discreet and convenient alternatives to surgery, manufacturers are embedding biofeedback mechanisms and digital connectivity into pelvic floor muscle training devices to enhance adherence and clinical outcomes. This shift towards digital therapeutics addresses the limitations of traditional conservative treatments by providing real-time visualization and progress tracking. Validating the efficacy of these modern solutions, according to Axena Health, July 2024, in the 'Axena Health shares new publication that adds more real-world evidence for the Leva Pelvic Health System' announcement, 74 percent of participants using the system experienced symptom improvement. Such advancements not only improve patient quality of life but also encourage wider adoption of device-based therapies as a first-line treatment standard.

Download Free Sample Report

Key Market Challenges

Stringent regulatory requirements and ongoing litigation regarding the safety of transvaginal mesh implants represent a critical impediment to the progression of the Global Female Stress Urinary Incontinence (SUI) Devices Market. This complex environment hampers growth by eroding surgeon confidence and deterring manufacturers from aggressive product development due to the threat of substantial liability claims. As regulatory bodies intensify scrutiny and demand more rigorous clinical data for device approval, companies face escalated compliance costs and prolonged market entry timelines. Consequently, this legal and regulatory volatility has shifted clinical practice patterns, causing many healthcare providers to reduce their usage of mesh-based devices in favor of conservative management.

This contraction in procedural volume is evidenced by recent industry data highlighting the lasting impact of these safety concerns. According to the 'American Urological Association', in '2024', 'the percentage of patients with stress urinary incontinence who underwent a sling procedure continued to decline to roughly 2.0% within the analyzed population'. Such trends indicate that fear of litigation and regulatory hurdles effectively suppresses the addressable market, limiting patient adoption of these devices despite the prevalence of the condition.

Key Market Trends

The emergence of High-Intensity Focused Electromagnetic (HIFEM) Chair Therapies is increasingly defining the market landscape, offering a completely passive, non-invasive treatment modality that contrasts sharply with active physical therapy. Unlike traditional conservative management or biofeedback systems that rely on patient effort and compliance, HIFEM technology utilizes electromagnetic energy to induce thousands of supramaximal pelvic floor muscle contractions in a single in-office session, delivering consistent therapeutic outcomes without physical exertion. This technology is witnessing rapid commercial uptake as clinicians seek to offer effective, zero-downtime alternatives to patients who are hesitant to undergo surgery or struggle with voluntary exercise regimens. Validating this expansion, according to Aesthetic Medical Practitioner, December 2024, in the 'BTL wins Best Non-Invasive Body Shaping Manufacturer' article, BTL Aesthetics reported having installed over 500 Emsella devices across the Asia-Pacific region alone, underscoring the significant global traction and provider adoption of this chair-based therapy.

Simultaneously, there is a pronounced shift towards Disposable and Over-the-Counter (OTC) Vaginal Support Inserts, driven by a growing consumer preference for immediate, on-demand symptom control independent of clinical settings. These mechanical devices provide discrete structural support to the urethra specifically during physical exertion, effectively bridging the therapeutic gap between absorbent pads and permanent surgical implants for women seeking autonomy in managing their condition. This trend signifies a democratization of care, moving away from purely prescription-based models toward accessible, patient-controlled solutions that can be purchased and utilized without long-term medical commitments. Highlighting the investment potential in this segment, according to Medical Product Outsourcing, April 2025, in the 'Uresta Debuts New Bladder Support Solution in U.S.' article, Uresta secured $3 million in funding to accelerate the commercialization of its reusable bladder support device, reflecting the industry's pivot toward scalable, consumer-centric innovations.

Segmental Insights

The Urethral Slings segment is recognized as the fastest-growing category within the Global Female Stress Urinary Incontinence (SUI) Devices Market. This upward trajectory is driven by the device's status as the clinical gold standard for minimally invasive treatment. Medical professionals increasingly favor these slings for their high efficacy and reduced recovery periods compared to traditional surgeries. Moreover, the U.S. Food and Drug Administration (FDA) has validated the safety of mid-urethral slings, explicitly distinguishing them from transvaginal mesh used for prolapse. This regulatory clarity has reinforced market confidence, driving rapid adoption across the global healthcare landscape.

Regional Insights

North America holds a dominant position in the global female stress urinary incontinence devices market, driven by a well-established healthcare infrastructure and a high prevalence of urological conditions among the aging population. This market leadership is supported by favorable reimbursement policies from the Centers for Medicare & Medicaid Services, which improve patient access to essential treatments. Additionally, the U.S. Food and Drug Administration provides clear regulatory guidelines that facilitate the approval and commercialization of safe medical devices. These factors, alongside the presence of major industry manufacturers, ensure consistent market stability and growth within the region.

Recent Developments

• In May 2024, Watkins-Conti Products obtained FDA 510(k) clearance for the Yōni.Fit Bladder Support device, a novel solution for the management of female stress urinary incontinence. This clearance allows the company to market the soft, self-administered vaginal insert, which is designed to reduce urine leakage without interfering with voluntary urination. The regulatory approval was supported by clinical data from a randomized controlled trial that evaluated the device's efficacy and safety. The product offers a non-surgical option for women seeking temporary management of SUI symptoms during specific activities or for up to 12 hours.
• In February 2024, UroMems announced a significant clinical milestone with the successful six-month primary endpoint results for the first female patient implanted with the UroActive System. This smart, automated artificial urinary sphincter (AUS) is being developed to treat stress urinary incontinence by compensating for sphincter insufficiency. The data from this first-in-female feasibility study demonstrated that the device met its safety and performance goals, with no need for revision and successful device activation. The positive outcome marked a critical step in the development of this new active implantable technology for women suffering from involuntary urinary leakage.
• In January 2024, Boston Scientific Corporation entered into a definitive agreement to acquire Axonics, Inc. for approximately $3.7 billion in cash. This strategic acquisition aimed to expand Boston Scientific’s urology portfolio with the addition of the Axonics technology platform, which includes the Bulkamid Urethral Bulking System. Bulkamid is a minimally invasive, hydrogel-based treatment widely used for the management of female stress urinary incontinence. The transaction was designed to strengthen the company’s position in the high-growth pelvic health market and provide urologists with a more comprehensive suite of solutions for treating incontinence.
• In January 2024, UroCure and LiNA Medical USA announced the nationwide launch of two new surgical devices for the treatment of female stress urinary incontinence: the ArcSP Suprapubic Sling System and the ArcTO Transobturator Sling System. These product launches complemented the companies' existing transvaginal sling offering, providing surgeons with a complete range of sling configurations—top-down, outside-in, and bottom-up—to suit different clinical techniques. The devices feature UroCure’s laser-cut sling technology with an integrated stabilizing suture, designed to maintain the sling’s structure and prevent deformation during placement and tensioning.

Key Market Players

• Coloplast
• Boston Scientific
• Cook Medical
• Axonics
• Neomedic
• Mentor
• Hollister
• A.M. Surgical
• Uroplasty Lines

By Product Type	By End-user	By Region
Urethral Slings Catheters Vaginal Pessaries Others	Hospitals & Ambulatory Surgical Centers (ASCs) Specialty Clinics Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Female Stress Urinary Incontinence (SUI) Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Female Stress Urinary Incontinence (SUI) Devices Market, By Product Type:

• Urethral Slings
• Catheters
• Vaginal Pessaries
• Others

• Female Stress Urinary Incontinence (SUI) Devices Market, By End-user:

• Hospitals & Ambulatory Surgical Centers (ASCs)
• Specialty Clinics
• Others

• Female Stress Urinary Incontinence (SUI) Devices 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