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Female Incontinence & Vaginal Prolaspe

Pelvic Prolapse Resources

What is Pelvic Prolapse?
Pelvic Floor Reconstruction?
Types of Prolapse?
Download Patient Guide on Pelvic Prolapse

Incontinence Resources

What is Stress Urinary Incontinence?
Conditions that cause Stress Urinary Incontinence
How can a mid-urethral sling system help my incontinence?
What can I expect during my sling procedure?
A minimally invasive approach to treating Stress Urinary Incontinence
What to expect after the procedure
Download Patient Guide on Stress Urinary Incontinence (SUI)

Coaptite Injectable Implant for the treatment of Incontinence in women

Introduction
Contraindication & Warnings
What are the risks?
Are there other options?
What are the benefits of Coaptite Implant Injections?
What can I expect during my procedure with the Coaptite Implant Injection?
Download Patient Guide on Coaptite Injectable Implant

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Pelvic Prolapse

When an organ becomes displaced, or slips down in the body, it is referred to as a prolapse. Your physician has diagnosed you with a pelvic organ prolapse if part of the vagina has become weakened or displaced.

Women affected by pelvic prolapse sometimes refer to their “dropped bladder” or “fallen uterus.” In the medical profession, these conditions are referred to in more technical terms – such as “cystocele”, “uterine prolapse” or “rectocele”, which will be explained in this brochure.

Symptoms of pelvic prolapse can include pressure or discomfort in the vaginal or pelvic area, often made worse with physical activities such as prolonged standing, jogging or bicycling. For other women, diminished comfort and control in the bladder and/or the bowels can be an indicator of a worsening prolapse condition.

Vaginal prolapse can be treated in several ways, depending on the exact nature of the prolapse and its severity. You and your physician may discuss:

  • Changes to your diet and fitness routine
  • Considering a “pessary” – a rubber or plastic device, inserted vaginally and designed to relieve symptoms when in place
  • Surgical procedures to improve the prolapse. In recent years, dramatic advances have been made in the surgical treatment of this common gynecological condition

This patient guide will help discuss the various types of prolapse, and the surgical procedures that may help to improve your prolapse.


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What is Pelvic Floor Reconstruction?

Pelvic prolapse repairs can be performed in a few basic ways:

(1) through vaginal incisions, (2) through traditional abdominal incision, or (3) through a laparoscopic approach. In recent years, general trends have favored vaginal repair techniques – as they often provide excellent outcomes.

Surgical repairs for prolapse sometimes involve the placement of ‘mesh’ or ‘graft’ materials, to reinforce areas of weakened tissues. This is especially common with the repair of more advanced prolapse conditions, or cases where a previous operation has failed.


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Types of Prolapse

Cystocele: The Bulging Bladder: is often referred to as a dropped bladder, and it is one of the most common prolapses within the vagina among women following pregnancy and childbirth. A cystocele forms when the normally flat upper vaginal wall loses its support and sinks downward. This allows the bladder, which is located right above the upper vaginal wall, to drop right along with it. When a cystocele becomes advanced, the bulge may become visible outside the vaginal opening. The visible tissue is the weakened vaginal wall; the bladder is right behind the skin but cannot be seen. The symptoms caused by cystoceles can include vaginal bulging or pressure, slowing of the urinary stream, overactive bladder symptoms, and an inability to fully empty the bladder.

Enterocele The Female Hernia: When the intestines bulge downward into the upper vagina, then you have an enterocele. It’s the last of the pelvic bulges you should know about, and the most difficult to conceptualize. Among all types of female prolapse, enteroceles share the most similarities with hernias that can develop in the abdominal and groin areas of both women and men: both involve bulging of the intestines into weakened supports nearby. In a man, hernias bulge through the abdominal wall; in a woman, enteroceles bulge into the top of the vagina. The symptoms are often vague, including a bearing down pressure in the pelvis and vagina, and perhaps a lower backache. They often exist alongside vaginal vault prolapse in women who have had a hysterectomy.

Rectocele The Bulging Rectum: is the mirror image of a cystocele. Cystoceles result from a weak upper vaginal wall, allowing the bladder to bulge downward, while rectoceles result from a weak lower vaginal wall, allowing the rectum to bulge upward. This creates an extra pouch in the normally straight rectal tube.

Rectoceles cause symptoms related to incomplete emptying of the rectum, just like the cystoceles cause incomplete emptying of the bladder. But unlike cystoceles, which tend to cause few symptoms until they become quite large, rectoceles often cause symptoms in their early stages. Even a rectocele bulge that cannot be visualized at the vaginal opening may cause difficulty with bowel movements – including the need to strain more forcefully, a feeling of rectal fullness even after a bowel movement, increased fecal soiling, and in some cases incontinence of stool or gas. Those symptoms result from stool and air remaining within the rectocele pouch even after defecation, in contrast to the normal rectum, which fully empties. Larger rectoceles can bulge right through the vaginal opening and look like a cystocele, although this time it is the lower vaginal wall accounting for the bulge.

Vaginal Vault Prolapse: If you have already had a hysterectomy, the top of the vagina (called the vault or apex) should be attached to supportive ligaments on either side of the pelvis. These attachments prevent the top of the vagina from bulging outward beneath the constant pressure of the abdominal contents. However if these attachments weaken and the vaginal apex drops, a bulge may form near the vaginal opening. This is called vaginal vault prolapse, a condition that only happens to women who have had a hysterectomy, and one that can cause severe pressure and bulging symptoms. Similar to cystoceles,
rectoceles and uterine prolapse, some case of vaginal vault prolapse can be managed with simple devices. Surgical repair is also common and can be performed by a number of vaginal, abdominal, and even laparoscopic techniques.


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What is Stress Urinary Incontinence?

Urinary incontinence is defined as the involuntary leakage of urine. The problem afflicts approximately 13 million adults in the United States, 85% of them being women. There are many conditions that can cause loss of bladder control. Among women, the problem is most commonly associated with a specific condition called Stress Urinary Incontinence or SUI. Stress urinary incontinence is the involuntary loss of urine during physical activity such as coughing, laughing, or lifting. The muscles that support the urethra (the small tube that carries urine out of the body) and bladder neck (the opening that connects the urethra to the bladder) have weakened, causing the urethra to drop during physical activity, resulting in urine leaking out of the body. This type of incontinence can be treated both surgically and nonsurgically. The next few pages will describe a minimally invasive surgical approach called a sling procedure.


Conditions that cause Stress Urinary Incontinence

The first condition is called hypermobility, (“hyper” means too much and “mobility” refers to movement) which is a common condition resulting from childbirth, previous pelvic surgery or hormonal changes. Hypermobility occurs when the normal pelvic floor muscles can no longer provide the necessary support
to the urethra and bladder neck. As a result, the bladder neck is free to drop when any downward pressure is applied and thus, involuntary leakage occurs. The second condition is called intrinsic sphincter deficiency, usually called ISD. This medical term refers to the weakening of the urethral sphincter muscles or closing mechanism. As a result of this weakening, the sphincter does not function normally regardless of the position of the bladder neck on urethra.


How can a mid-urethral sling system help my incontinence?

A minimally invasive sling procedure using a mid-urethral sling system is designed to provide a ribbon of support under the urethra to prevent it from dropping during physical activity. The dropping of your urethra out of the correct anatomical position may be what causes your incontinence. Providing support that mimics the normal anatomy should prevent urine from leaking or reduce the amount of leakage.


What can I expect during my sling procedure?

Your sling procedure with a mid-urethral sling system will take an estimated 30-45 minutes. Dr. Sunkavally will determine the type of anesthesia you will have during the procedure. Once the anesthesia takes effect, Dr. Sunkavally will begin the procedure. A small incision will be made in the vaginal area and two small incisions will be made through the skin in the groin area. Next, the synthetic mesh is placed. When it is placed, it will extend from one skin incision, in towards the vagina, around the urethra and back out though the second skin incision. This creates a “hammock” of support around the urethra. Dr. Sunkavally will adjust the mesh tension so that the leakage of urine is reduced. When Dr. Sunkavally is satisfied with the position of the mesh, he or she will close and bandage the small incisions in the groin area and the top of the vaginal canal.


A minimally invasive approach to treating Stress Urinary Incontinence

Many surgical options have been developed for the correction of SUI due to hypermobility and/or ISD. Boston Scientific offers many different minimally invasive procedures, the difference being in the placement of the “anchoring” location of the mesh material. Dr. Sunkavally will recommend which anchoring location is right for you.

The sling system is designed to add support to the urethra and stabilize it as well. With the sling system in place, normal urinary function may be restored.


What to expect after the procedure

To help with the healing process, a catheter may be placed into your bladder. The catheter will be connected to a drainage bag, which will collect your urine. The catheter will be removed within a short period of time. After the procedure is complete, specialized nurses will monitor you. You will probably be discharged within 24 hours.

Before your discharge from the hospital, Dr. Sunkavally and nurse will provide you information on what to expect and how to care for yourself during your recovery time. Below are a few things included in these instructions:

  • You may be given a prescription for an antibiotic. It is important to take the medication as
    prescribed.
  • You may be given a prescription for pain medication. If not, your physician or nurse may recommend an over-the-counter drug that should relieve any discomfort you may experience.
  • If you need to go home with a catheter, your physician or nurse will also instruct you on how to take care of it.
  • You will be instructed on how to care for your incision area.
  • Routine physical activity may be restricted for a short time after the procedure. Strenuous activity may be restricted for 6-12 weeks. Dr. Sunkavally or nurse will provide you with specific guidelines.


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Coaptite Injectable Implant

The Coaptite Injectable Implant is a material that is used to bulk or fill out the tissues surrounding the urethra to provide additional support during physical activity. The Coaptite Implant is made of round particles made of calcium hydroxylapatite, which is a natural component of your teeth and bones, in a water-based gel.

Stress Urinary Incontinence is the involuntary loss of urine during physical activity such as coughing, laughing or sneezing. The round muscle (sphincter) used to keep urine in the bladder can become weak and urine leaks out during these activities (See Figure 1). This type of incontinence is treated both surgically and non-surgically. Bulking with the Coaptite Injectable Implant increases the resistance of the urethra to urine leakage.

This brochure is to help you make a decision as to whether or not to have a urethral bulking procedure with the Coaptite Injectable Implant. Over 13 million adults have Stress Urinary Incontinence in the United States, 85% of these adults being women. Coaptite Implant treatment is only one way to treat Stress Urinary Incontinence. Your physician will provide you with recommended options for treating your incontinence and help you make the right treatment decision.


Contraindication

You should not have the procedure at this time if you have inflammation of the bladder (cystitis) or the urethra (urethritis) or other infections. Tell Dr. Sunkavally if you have pain when you urinate or if you urinate often because these may be signs of a urinary tract infection. After your infection is treated, using the Coaptite Injectable Implant treatment can be considered.

Warnings

  • Narrowing of the bladder neck or urethra is called a urethral stricture. Your urethra could be blocked and you may not be able to pass urine if you are treated when you have these strictures. Tell Dr. Sunkavally if you have to strain in order to start urinating. This may be a symptom of a stricture. Dr. Sunkavally will be able to discuss the treatment options for urethral strictures.
  • Safety and effectiveness of the Coaptite Injectable Implant in pregnant women is unknown. It is unknown whether the Coaptite Implant treatment will harm you or your baby if you are pregnant. It is unknown whether the Coaptite Implant treatment will relieve your stress urinary incontinence if you are pregnant.
  • If Dr. Sunkavally injects too much of the Coaptite Implant, you may not be able to urinate. If this happens, the
    doctor may have to put a catheter in you until you can urinate normally.
  • The Coaptite Implant may erode through your tissue. If that happens, surgery may be needed to repair the
    damaged tissue. In the study, 1 out of 158 patients developed this problem and had to have surgery to correct the problem.
  • The Coaptite Implant may not stay in place where it is injected and this can lead to complications.
  • Contact Dr. Sunkavally if you have any problem that bothers you or lasts longer than 24 hours after your Coaptite Implant bulking procedure. If you do not contact your doctor, your problem may get worse and harm you.
  • Women with peripheral vascular disease and prior pelvic surgery, e.g., hysterectomy or surgery for urinary
    incontinence, may be at increased risk for tissue erosion.


What are the risks of Coaptite® Implant injections?

In the clinical study, 158 patients were treated with the Coaptite Injectable Implant and followed for 12 months after the initial treatment. The adverse events reported included:

  • Retention (41%)
  • Blood in the urine (20%)
  • Painful urination (15%)
  • Urinary tract infection (8%)
  • Urgency (8%)
  • Frequent urination (7%)
  • Exposed bulking material (1%)

Most of these adverse events listed above happened within 24 hours and went away within 30 days.

The Coaptite Injectable Implant did not stay in place where it was injected. As a result, two patients experienced a serious adverse event. One required corrective surgery and the other did not. See the Warning Section to the left for more information.

You may require more than one treatment to achieve dryness or satisfactory improvement, or the Coaptite Implant may not help at all.

It is unknown how long Coaptite Implant treatment will last. So far it has been shown to last at least one year. Over time, the calcium hydroxylapatite (CaHA) particles should break down and be taken up by the body. Some data shows that the CaHA particles can still be there after 3 years, but everyone is different and they may not be there as long for you.


Are there other options?

There are also other ways to treat your problem. They can be non-surgical, including strengthening exercises for the pelvic muscles to improve support of the bladder and urethra, and biofeedback to assist in retraining the pelvic muscles. Drugs, as well as treatment with other bulking agents can help. Surgical procedures can repair and reposition organs, restore support to weakened pelvic muscles, or implant an artificial urinary sphincter. You should discuss these treatment options with Dr. Sunkavally.


What are the benefits of Coaptite Implant Injections?

The Coaptite Injectable Implant may benefit you because it may help you become dry or lessen the amount of urinary leakage. The Coaptite Implant is made of round particles of CaHA in a water-based gel. The body takes up the gel. The particles remain to act as a space filling bulk, causing the closing of the urethra.

In the study, 83 out of 131 (63%) of patients were improved at 12 months following treatment with the Coaptite Injectable Implant. Fifty-one out of 131 (34%) of the patients were dry. A majority of the patients (82 out of 131) (62%) had more than one injection of the Coaptite Implant. Thirteen of 131(10%) patients got worse after one year. For 35 patients (27%), we do not know if they improved, remained the same, or got worse.


What can I expect during my procedure with the Coaptite Implant Injection?

The procedure will take place in a doctor's office, an outpatient surgery center or in an operating room. The
procedure takes approximately 15-20 minutes. Dr. Sunkavally will determine what type of anesthesia is best for you. During the procedure, a needle is placed into the urethra (See Figure 2) using a cystoscope and the Coaptite Implant is injected into the tissues surrounding your urethra providing a bulking effect. The doctor removes the needle and the procedure is completed. After the procedure, you will stay in the office or recovery room until you are able to pass urine on your own, usually within a few hours. Dr. Sunkavally will talk to you so you know what to expect from your treatment.

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