Pacey Cuff Male Incontinence Clamp
A non-surgical, external non-invasive male incontinence clamp.
Product detail →Surgical Implant Artificial urinary sphincter (AUS)
ZSI 375 PF artificial urinary sphincter.
A two-component artificial sphincter designed for the surgical treatment of moderate to severe male urinary incontinence. Because the pressure-regulating balloon is integrated into the scrotal pump unit, it requires no component in the pelvic region; the system is supplied pre-connected, pre-filled and ready for implantation. The content is institutional technical information for healthcare professionals and procurement teams; it contains no patient referral or treatment advice.
01 Overview
A two-component system that mimics intrinsic sphincter function.
ZSI 375 PF, developed by the Switzerland-based Zephyr Surgical Implants, is an artificial urinary sphincter (AUS). The device is implanted to support the function of the natural urinary sphincter that restricts urine outflow from the bladder, and it mechanically mimics intrinsic sphincter behaviour.
The system's most distinctive design decision is the reduction of the component count to two: the inflatable, adjustable cuff placed around the urethra and the scrotal pump unit housing the pressure-regulating balloon. The reservoir placed in the pelvis in classic three-component systems is eliminated here; there is no component whatsoever in the pelvic region. This approach eliminates the need for pelvic dissection and simplifies surgical planning in cases with a history of previous pelvic surgery or radiotherapy.
The device comes out of the box pre-connected and pre-filled and ready for implantation. This aims to eliminate connection and filling steps in the operating theatre and thereby reduce the risk of connection error and the manipulation time. The implant remains entirely inside the body and is not visible externally.
Lisa Health provides hospitals and functional urology teams with documented supply of the ZSI surgical implant portfolio, cuff sizing planning support and operating theatre preparation documentation. The clinical decision and determination of indication rest solely with the specialist physician.
✓ Two-component system
✓ No pelvic component required
✓ Cuff 4–6 cm, curved
✓ Pre-connected & pre-filled
✓ 5-year warranty
✓ Swiss-made
02 Clinical indications
In which patients is it considered?
The artificial urinary sphincter is positioned as the surgical standard option in sphincteric insufficiency where conservative methods are not sufficient. The headings below summarise the clinical contexts most often considered; the final indication, urodynamic assessment and patient suitability are determined solely by the specialist urology team.
- Post-prostatectomy incontinence: moderate to severe stress urinary incontinence after radical prostatectomy; cases that do not respond to pelvic floor rehabilitation.
- Post-TURP incontinence: sphincteric insufficiency developing after surgery for benign prostatic hyperplasia.
- Incontinence after radiotherapy: in selected cases with a history of pelvic irradiation; the construction without a pelvic component simplifies planning.
- Neurogenic sphincter insufficiency: selected cases with insufficient outlet resistance in the setting of a neurogenic bladder.
- Sphincter damage after trauma: loss of sphincter integrity after pelvic trauma or urethral surgery.
- Cases where external devices are insufficient: patients for whom management with a continence clamp or absorbent products is not considered clinically adequate.
Contraindications, active urinary infection, urethral stricture, detrusor overactivity and the patient's manual dexterity/compliance are addressed within the framework of the current instructions for use and clinical protocols.
03 Structure and components
Cuff and pump: two parts, zero pelvic components.
The device is manufactured from medical-grade silicone elastomer and delivered ready for implantation. The design focuses on reducing the number of surgical steps and intraoperative manipulation.
- Inflatable, adjustable cuff: placed around the urethra; its curved design and adjustable construction were developed to accommodate different urethral diameters.
- Quick cuff lock: a button-based closure mechanism; described by the manufacturer as simple and secure.
- Temporary extension tab: an auxiliary element that eases placement of the cuff around the urethra and is removed after the procedure.
- Pump unit (scrotal): it has large, easily accessible buttons for activation/deactivation; the pressure-regulating balloon is integrated inside this unit.
- Hydraulic septum: accessible through the scrotum; it allows the system fluid volume to be adjusted interventionally.
- Silencer: a design element intended to reduce operating noise.
- No pelvic component: because no reservoir is placed in the pelvis, pelvic dissection is not required.
- Material: the entire structure is manufactured from medical-grade silicone elastomer.
04 Operating principle
The continence cycle in four steps.
The system works as a closed hydraulic circuit and, thanks to its automatic re-inflation feature, restores continence without requiring patient intervention.
- 1 — Continence: the inflated cuff compresses the urethra; urine leakage is prevented.
- 2 — Desire to void: the patient squeezes and releases the pump in the scrotum.
- 3 — Micturition: the cuff deflates, the urethra is decompressed and the bladder is emptied.
- 4 — Automatic return: approximately 2–3 minutes later the cuff re-inflates on its own and continence is restored.
05 Technical parameters
Cuff size and system specifications.
| Parameter | Value | Clinical note |
|---|---|---|
| Number of components | 2 (cuff + pump unit) | Pre-connected and pre-filled |
| Cuff length | 4 – 6 cm | Curved design; the adjustable construction accommodates a wide urethral range |
| Pressure regulation | Balloon integrated into the pump unit | No separate pelvic reservoir required |
| Pump placement | Scrotum | Large activation/deactivation buttons |
| Pelvic component | None | Eliminates the need for pelvic dissection |
| Automatic re-inflation | ~2–3 minutes | Continence returns without patient intervention |
| Material | Medical-grade silicone elastomer | Designed for long-term implantation |
| Warranty | 5 years | Scope defined by the manufacturer |
The values are compiled from the manufacturer's catalogue; final parameters are confirmed with the official product documentation shared with the institution and the current instructions for use.
06 Distinguishing advantages
Highlights for the operating theatre and long-term follow-up.
- No pelvic component required: pelvic dissection and reservoir placement are eliminated; planning is simplified in patients with a history of pelvic surgery or radiotherapy.
- Reduced risk of connection error: the pre-connected and pre-filled system eliminates intraoperative assembly steps.
- Design addressing infection risk: reduced manipulation and component count are positioned by the manufacturer as contributing to a lower infection risk.
- Operating time: according to manufacturer data, the same theatre time as conventional approaches is targeted.
- Single cuff configuration: the adjustable 4–6 cm curved cuff covers different urethral diameters with a single reference, which simplifies stock management.
- Patient use: the large buttons in the scrotum and the automatic re-inflation simplify day-to-day use.
- Imaging and travel compatibility: designed for safe use in medical scanners; not detected by airport security scanners.
- Warranty: the manufacturer defines a warranty period of 5 years.
07 Positioning
Surgical implant or external device?
The treatment steps in male urinary incontinence are structured according to the patient's degree of incontinence, surgical suitability and preference. The table below summarises the institutional positioning of the surgical and non-invasive options in the portfolio; the clinical choice rests with the specialist physician.
| Criterion | ZSI 375 PF (surgical implant) | External clamp / strap |
|---|---|---|
| Approach | Surgical implantation | ✓ Non-invasive, no surgery |
| Degree of incontinence | ✓ Moderate – severe | Mild – moderate |
| Use | Permanent; inside the body, invisible | Applied and removed during the day |
| Continence mechanism | Controlled compression with a urethral cuff | External penile compression |
| Patient intervention | Deflation with the pump; automatic return | Manual opening/closing at every micturition |
| Portfolio equivalent | ZSI 375 PF | Pacey Cuff · Prosecca Strap |
08 Technical summary
Institutional evaluation table.
| Manufacturer / brand | Zephyr Surgical Implants (ZSI) — Geneva, Switzerland |
|---|---|
| Model | ZSI 375 PF |
| Product family | Surgical implant / male urinary incontinence |
| Product type | Artificial urinary sphincter (AUS) |
| Indication area | Moderate to severe urinary incontinence in men |
| Components | Inflatable adjustable cuff + scrotal pump with pressure-regulating balloon — pre-connected and pre-filled |
| Cuff | Curved, 4–6 cm; quick lock and temporary extension tab |
| Pelvic component | None |
| Material | Medical-grade silicone elastomer |
| Automatic re-inflation | Approximately 2–3 minutes |
| Additional design elements | Hydraulic septum (access through the scrotum), silencer, large activation buttons |
| Imaging compatibility | Safe use in medical scanners; not detected by airport scanners |
| Warranty | 5 years (manufacturer) |
| Regulatory status | CE-marked medical device; classification, ÜTS and TİTCK registration details are confirmed with the supply file |
| Documentation | CE certificates, instructions for use, cuff sizing file, surgical technique and training materials |
| Target audience | Urology and functional urology physicians, procurement and tender units |
09 Questions & answers
Frequently asked institutional questions.
What is an artificial urinary sphincter and how does it work?
An artificial urinary sphincter (AUS) is an implantable device that supports the natural urinary sphincter's function of restricting urine flow. In the ZSI 375 PF, the inflatable cuff placed around the urethra provides continence by compressing the urethra; when the patient squeezes and releases the pump in the scrotum, the cuff deflates, the urethra is decompressed and the bladder is emptied. After approximately 2–3 minutes the cuff automatically re-inflates and restores continence.
In which patients is the ZSI 375 PF considered?
The device is considered in cases of moderate to severe urinary incontinence in men; it most often comes into question in sphincteric insufficiency after radical prostatectomy. The indication, urodynamic assessment and patient suitability are determined solely by the specialist urology team.
What are the ZSI 375 PF cuff sizes?
The cuff has a curved design and offers a length between 4 cm and 6 cm. Its inflatable, adjustable construction is designed to accommodate different urethral diameters, so that a wide anatomical range is covered with a single cuff configuration.
What does it mean that the ZSI 375 PF requires no pelvic component?
In classic three-component systems the pressure-regulating reservoir is placed in the pelvis. In the ZSI 375 PF the pressure-regulating balloon is integrated inside the pump unit in the scrotum; there is no component whatsoever in the pelvic region. This eliminates the need for pelvic dissection and simplifies surgical planning, particularly in cases with a history of previous pelvic surgery or radiotherapy.
What is the warranty and documentation scope for the ZSI 375 PF?
The manufacturer defines a warranty period of 5 years. Cuff size options, set contents, CE and ÜTS documents, lot/serial traceability, the surgical technique document and the training plan are compiled according to the institution's procurement format. No public pricing is published.
10 Related products
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Explore the complementary products in the surgical implant family and the male incontinence portfolio.
Request the technical file for the ZSI 375 PF.
State your institution type, case profile and the documents you need, and we will respond with cuff sizes, surgical training and a quotation schedule.