Female Incontinence & Vaginal Prolaspe

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.

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.

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.

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.

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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