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Treating Stress Incontinence and Vesicoureteric Reflux
For decades particles suspended a in solution have have been injected to cause the narrowing of the urethra or ureter to prevent urine leaking in stress incontinence or reflux from the bladder back up the ureter into the kidneys.
Teflon is now not infrequently used because it has been shown to migrate into lymph nodes, lungs, liver, and other areas.Teflon reacts with surrounding tissue so there is a potential health risk depending on where particles lodge.
Collagen is still used, but because it is resorbed, the effect may last for only 6-12 months. Collagen is derived from cattle and questions have been raised as to its safety.
A silicone product comprising 200 micron jagged particles in a suspension gel is commonly used. However, questions have been raised as to the long term safety of this material and despite wide spread use in Europe, the American FDA has consistantly resisted licensing its sale in the USA. There have been reports of granuloma formation, autoimmune reactions and malignancy.
The shortcomings of the bulking materials have meant that many surgeons have provided this minimally invasive injection procedure only after failure of more major colposuspension procedures.
Now a material that is natural to the body and which provides a totally safe tissue augmentation is available. Many believe this product, Coaptite, will soon become the most widely used material for treating both Stress Incontinence and Vesicoureteric Reflux.
This material, 100 micron spheres of calcium hydroxylapatite, has a long history as an implant material and as it is a synthetic form of the major component of bone, it is tissue friendly.
an easy-to-inject, biocompatible and tissue
friendly augmenting product to treat
Stress Incontinence and Vesicoureteric Reflux
Coaptite comprises smooth 100 micron spheres of synthetic calcium hydroxylapatite
suspended in a mainly glycerine and water gel with a chemically-modified naturally
occuring polysaccharide sodium carboxymethylcellulose as support.
CaHA is natural to the body and is inert in soft tissue. Neither the
CaHA nor the gel cause tissue reaction or inflammation. There is no burning
sensation when Coaptite is injected. The smooth 100 micron spheres are densely
distributed in the gel so less material is needed for bulking.
The patented carrier gel remains in situ until tissue grows in to take its
place. Healthy
tissue grows through the deposit and against
the particles to form a tissue and Coaptite
matrix which remains soft and pliable.
The deposit remains localised and stationary within the injection site. There is no migration nor resorption.
Soft and pliable tissue and Coaptite explant
after 12 months
The three slides are from a dog bladder explanted 12 months after Coaptite injection.
Coaptite ™.
......The only solution to combine so many benefits.
- Neither Coaptite nor the carrier gel cause tissue reaction and no inflammation occurs.
- No capsule is formed.
- Healthy tissue grows without change against and through the smooth CaHA spheres to form a soft and pliable tissue and Coaptite matrix.
- There is no migration and no resorption.
- The 100 micron spheres are smooth and densely packed in the carrier gel so that on average only 2.5ml of material is needed for stress incontinence.
- Coaptite flows smoothly through the 21 guage needle with finger pressure control.
- Five year results are excellent. Patients dry after the procedure are still dry after 5 years.
- Radiopaque
- No sensitivity testing required. No special storage required.
Needle size: 21 guage Catheter size: 5 or 7 Fr to fit standard cystoscopes.
Mean Initial volume injected: 2.5cc Mean total volume: 3.9cc
GSI: Pretreatment mean 24-hr Pad weight: 104.87gm, and at 12 months: 1.46gm.¹
5 year follow-up data shows 12 and 37 month results persisting.
VUR: 80% resolved with one injection and 100% after second injection
²
1.Preliminary Evaluation of Calcium Hydroxylapatite as a Transurethral
Bulking Agent for Stress Urinary
Incontinence. Robert Mayer et
al UROLOGY 57 (3), 2001
2. FDA study. Prof R. A. Mevorach, Univ of Rochester Medical
Center, Rochester, NY.