Urethral Bulking Injection

Coaptite urethral bulking injection provides coaptation of the bladder neck and/or mid-urethra for women who have stress urinary incontinence (SUI). This long lasting* yet non-permanent option provides a less invasive choice to meet the individual treatment goals of each SUI patient.3

Coaptite Product image 1
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Coaptite Product Image 3
Coaptite injection procedure
  • Coaptite Product image 1
  • Coaptite Product Image 2
  • Coaptite Product Image 3
  • Coaptite injection procedure
  • Rigid Needle — Designed for patient comfort, to reduce trauma to surrounding tissue and to guide placement.
  • Easy-to-Use Syringe — Comfortable fit in hand without need for additional administration device.
  • Coaptite injection is used to obtain closure at the bladder neck to mid-urethra.

Coaptite urethral bulking injection provides coaptation of the bladder neck and/or mid-urethra for women who have stress urinary incontinence (SUI). This long lasting* yet non-permanent option provides a less invasive choice to meet the individual treatment goals of each SUI patient.3

Product Details

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Ordering Information

Ordering Information Image
How To Order
  • Coaptite Product image 1
  • Coaptite Product Image 2
  • Coaptite Product Image 3
  • Coaptite injection procedure
  • Rigid Needle — Designed for patient comfort, to reduce trauma to surrounding tissue and to guide placement.
  • Easy-to-Use Syringe — Comfortable fit in hand without need for additional administration device.
  • Coaptite injection is used to obtain closure at the bladder neck to mid-urethra.

*based on 36-month data

Product Details

Safe, inherently biocompatible material

  • Biodegradable, composed of particles made of the same components that make up bone and teeth, and a saline-based carrier gel
  • Forms an even distribution of particles with a degree of interstitial space that creates a scaffold for possible tissue ingrowth
  • Adds volume to coapt the urethra for women who suffer from SUI due to intrinsic sphincteric deficiency (ISD)

Procedural ease-of-use

  • Designed to provide procedural ease-of-use and durability without the need for additional, bulky administration devices
  • Achieves comparable outcomes to traditional, gold-standard bovine collagen* with fewer re-injections and less material volume
Rigid Needle
  • Small, 21 mm gauge needle designed for patient comfort
  • Designed to reduce product extravasation and trauma to surrounding tissue
  • Circumferential needle markings help to guide placement
Easy-to-Use Syringe
  • Comfortable fit in hand without need for an additional administration device
  • Allows smooth, consistent pressure to prevent material from occluding needle

Post-Approval Study Demonstrates Long-Lasting Relief and High Efficacy

Coaptite maintains high success rates through 3 years2

Success rates infographic.

Comparable efficacy to traditional bovine collagen3

Comparable efficacy infographic.

A More Natural Bulk

Coaptite's inherently biocompatible material not only provides volume, it also facilitates the in-growth of new tissue in the area injected.1

Less Volume, Less Hassle

Less material volume means fewer syringe exchanges, potentially reducing time in the procedure and the risk of needle movement during injections.3

Sinlge injection vs total injection infographic.

Ordering Information

All orders and/or product questions should be directed to us either via Customer Solutions by calling 1-855-4MERZTX (855-463-7989) or via online order. If you are a new Merz customer, please reach out directly to Customer Solutions by calling 855-4MERZTX (855-463-7989) to establish an account.

Product Code Description
8005M0 Coaptite® Implant, 1 ml syringe each
9012M0 Rigid Needle, 21 ga X 37 cm, Pencil Point

Summary of Clinical Trials

See how the Coaptite® Injectable Implant, a natural, minimally invasive option for effective SUI relief compares to other bulking agents and clinical trial outcomes.

View full summary

*Based on 36-month data.

  1. Chapple C, Dmochowski R. Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence. Res Rep Urol. 2019;11:299-310. Published 2019 Nov.
  2. Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence Post-market Study. Clinical Study Report Protocol #P1005185. Merz North America, Inc. Coaptite P040047/R027. OSB Lead PMA Post-Approval Study Report. June 14, 2018.
  3. Mayer RD, Dmochowski RR, Appell RA, et al. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology. 2007;69(5):876-880.

IMPORTANT SAFETY INFORMATION FOR COAPTITE®

INDICATIONS:

Coaptite Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (lSD) in adult females.

CONTRAINDICATIONS:

The Coaptite Injectable Implant is contraindicated for use in a patient: who has significant history of urinary tract infections without resolution; who has current or acute conditions of cystitis or urethritis; who has fragile urethral mucosal lining.

POTENTIAL ADVERSE EVENTS that may occur include: Urinary Tract Infection, Cystitis, Vulvovaginal Mycotic Infection, Urinary Retention, Urge Incontinence, Micturition Urgency, Pollakiuria, Hematuria, Nocturia, Urethritis non-infective, Hemorrhage Urinary Tract, dysuria, erosion, erythema, embolic phenomena, and vascular occlusion.

WARNINGS:

  • Note: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. WARNING: Following injection of The COAPTITE Injectable Implant, dissection of the device through tissue may lead to 1) tissue erosion and may require corrective surgery or 2) elevation of the bladder wall causing ureteral obstruction. This may be caused by improper injection technique using The COAPTITE Injectable Implant. Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of The COAPTITE Injectable Implant.
  • The COAPTITE Injectable Implant in patients with urethral or bladder neck strictures should not be used until the strictures have been corrected.
  • Use in patients with strictures may cause injury and/or urethral obstruction.
  • Avoid using in patients with non-viable tissue, e.g., history of significant pelvic irradiation, multiple pelvic surgeries, etc. Scar tissue and significantly compromised tissue will not coapt appropriately.
  • Avoid using in patients with very short urethras and who have had multiple surgeries for stress incontinence. These patients may experience urethral caruncle formation.
  • Over correction using the COAPTITE Injectable Implant may lead to obstruction.
  • Avoid injecting in blood vessels. The COAPTITE Injectable Implant injection into blood vessels may cause vascular occlusion.

PRECAUTIONS:

  • The long-term safety and effectiveness of the COAPTITE Injectable Implant treatment has not been established.
  • Safety and effectiveness of the COAPTITE Injectable Implant in patients with the following conditions has not been established - Urinary incontinence due to detrusor instability, Bladder neuropathy, Nocturnal enuresis (bed wetting), Prolapsed bladder, Overflow incontinence, Functional incontinence.
  • Safety and effectiveness of the COAPTITE Injectable Implant in patients that are pregnant, or lactating has not been established.
  • The effect of the COAPTITE Injectable Implant on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of the COAPTITE Injectable Implant, is unknown. Therefore, the risks and benefits of the implant in women of childbearing potential should be carefully assessed.
  • Patients should be counseled that one or more repeat injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence.

Disclaimers: Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.

Coaptite Injectable Implant is commonly referred to as Coaptite Urethral Bulking Injection. All trademarks are the property of their prospective owners.

Please see Instructions for Use for COAPTITE or call Merz Customer Service at 55-MERZTX (855-463-7989).

IMPORTANT SAFETY INFORMATION FOR COAPTITE®

INDICATIONS:

Coaptite Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (lSD) in adult females.

CONTRAINDICATIONS:

The Coaptite Injectable Implant is contraindicated for use in a patient: who has significant history of urinary tract infections without resolution; who has current or acute conditions of cystitis or urethritis; who has fragile urethral mucosal lining.

POTENTIAL ADVERSE EVENTS that may occur include: Urinary Tract Infection, Cystitis, Vulvovaginal Mycotic Infection, Urinary Retention, Urge Incontinence, Micturition Urgency, Pollakiuria, Hematuria, Nocturia, Urethritis non-infective, Hemorrhage Urinary Tract, dysuria, erosion, erythema, embolic phenomena, and vascular occlusion.

WARNINGS:

  • Note: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. WARNING: Following injection of The COAPTITE Injectable Implant, dissection of the device through tissue may lead to 1) tissue erosion and may require corrective surgery or 2) elevation of the bladder wall causing ureteral obstruction. This may be caused by improper injection technique using The COAPTITE Injectable Implant. Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of The COAPTITE Injectable Implant.
  • The COAPTITE Injectable Implant in patients with urethral or bladder neck strictures should not be used until the strictures have been corrected.
  • Use in patients with strictures may cause injury and/or urethral obstruction.
  • Avoid using in patients with non-viable tissue, e.g., history of significant pelvic irradiation, multiple pelvic surgeries, etc. Scar tissue and significantly compromised tissue will not coapt appropriately.
  • Avoid using in patients with very short urethras and who have had multiple surgeries for stress incontinence. These patients may experience urethral caruncle formation.
  • Over correction using the COAPTITE Injectable Implant may lead to obstruction.
  • Avoid injecting in blood vessels. The COAPTITE Injectable Implant injection into blood vessels may cause vascular occlusion.

PRECAUTIONS:

  • The long-term safety and effectiveness of the COAPTITE Injectable Implant treatment has not been established.
  • Safety and effectiveness of the COAPTITE Injectable Implant in patients with the following conditions has not been established - Urinary incontinence due to detrusor instability, Bladder neuropathy, Nocturnal enuresis (bed wetting), Prolapsed bladder, Overflow incontinence, Functional incontinence.
  • Safety and effectiveness of the COAPTITE Injectable Implant in patients that are pregnant, or lactating has not been established.
  • The effect of the COAPTITE Injectable Implant on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of the COAPTITE Injectable Implant, is unknown. Therefore, the risks and benefits of the implant in women of childbearing potential should be carefully assessed.
  • Patients should be counseled that one or more repeat injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence.

Disclaimers: Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.

Coaptite Injectable Implant is commonly referred to as Coaptite Urethral Bulking Injection. All trademarks are the property of their prospective owners.

Please see Instructions for Use for COAPTITE or call Merz Customer Service at 55-MERZTX (855-463-7989).