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The Colpexin Sphere

An innovative Intra-Vaginal Device offering pelvic organ support while strengthening pelvic floor muscles It's easy, it's uplifting, it's COLPEXIN SPHERE Intra-Vaginal Device

About Colpexin

The Colpexin Sphere is an intravaginal device designed to treat pelvic organ prolapse and enhance the performance of pelvic floor muscle exercises.

The COLPEXIN SPHERE Product image

Product Description

The Colpexin Sphere is a smooth, round sphere made of medical grade polycarbonate plastic with an attached braided nylon string for easy removal. It provides dual benefits for the management of pelvic organ prolapse and improvement of pelvic floor muscle weakness. The Colpexin Sphere is available only by prescription.

How the Colpexin Sphere works

It's simple and safe

The Colpexin Sphere is an intravaginal device that elevates and supports the pelvic organs that may be used with pelvic floor muscle exercises to treat pelvic organ prolapse (sometimes called "POP"). The Colpexin Sphere is inserted into the vagina using the provided applicator or by hand and should be used as part of a program that includes pelvic floor muscle exercises. The Colpexin Sphere is available by prescription only.

About Colpexin

Is it right for me?

the Colpexin Sphere If you are experiencing the symptoms of pelvic organ prolapse or pelvic muscle weakness such as:

  • Pelvic pressure
  • Lower back pain
  • Loss of urine or stool
  • Inability to urinate or move your bowels
  • A feeling of something falling out of your vagina
  • A bulge in your vagina

You may be a candidate for Colpexin. Only a health care professional can diagnose these conditions and decide if the Colpexin Sphere is right for you.

About Colpexin

Safety Information

Contraindications

You should not use the Colpexin Sphere if you have any of the following:

  • Vaginal infection, breaks in the vaginal skin, or abnormal vaginal/uterine bleeding
  • You have had recent vaginal surgery
  • Severe pelvic nerve damage with no perineal sensation
  • Pelvic inflammatory disease, endometriosis, pelvic mass, prolapse limited to a large rectocele, or retroversion of the uterus
  • Pregnancy
  • You have an intrauterine device (IUD)
  • During sexual intercourse
  • During menstruation

Warnings

Contact your health care professional immediately if you experience any changes in color, amount, odor, and consistency of vaginal discharge, and/or if you have bleeding, discomfort, burning with urination, increased urinary frequency, and/or vaginal itching.

Cautions

The Colpexin Sphere should not be worn continuously for longer than 24 hours without removing and properly cleaning the device. (See Instructions for Care in Patient Product Information). Remember to remove the device before having sexual intercourse.

What Every Woman Needs to Know about Toxic Shock Syndrome

An association has not been established between the use of the Colpexin Sphere and toxic shock syndrome (TSS). However, wearing the device for prolonged periods of time may promote the growth of certain bacteria in the vaginal tract, especially during menstruation. Under certain conditions, the overgrowth of these bacteria could lead to symptoms of toxic shock syndrome. Primary symptoms of TSS are sudden high fever (usually 102°F or more), vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like sunburn. There may also be other signs of TSS, such as aching of muscles and joints, redness of the eyes, sore throat, and general weakness. If you have a sudden high fever and one or more of the other symptoms, remove the Colpexin Sphere at once and consult your health care professional immediately.

About Pelvic Organ Prolapse

What is it?

To understand what Colpexin is prescribed for, you need to understand the pelvic floor. The pelvic floor is a group of muscles, ligaments, and connective tissues that form a bowl or hammock, to support the pelvic organs (bladder, rectum and uterus) and keep the organs in place. In women, the pelvic floor muscles form a sort of supportive sheet with an opening for the urethra, vagina and rectum. Like a trampoline or net the pelvic floor muscles are attached to the fixed framework of the pelvic bones.

Pelvis, Normal
Pelvic organs
The pelvic organs and pelvic floor muscles
click here to enlarge

In addition to supporting the pelvic organs, the pelvic floor muscles assist in stopping and starting the flow of urine or the passage of gas or stool (bowel movement) and aid in sexual intercourse or stimulation. When these muscles contract or pull together, women sense deep feeling or tension and firmness as the tailbone moves toward the pubic bone and the openings of the vagina and anus close. Here's an illustration that shows you a woman's lower abdomen, including the pelvic floor muscles and organs we're talking about. You can see how everything is connected.

What happens with pelvic organ prolapse?

Pelvic organ prolapse, sometimes called just prolapse or POP for short occurs when one or more of the pelvic organs (bladder, rectum and uterus) pushes against the weakened wall of the vagina. Pelvic organ prolapse occurs when the pelvic muscle support system is weakened. It's common among women of all ages and can occur at any time, especially following childbirth.

About Pelvic Organ Prolapse

What are the symptoms of pelvic organ prolapse?

In the early stages of pelvic organ prolapse, you may not notice any symptoms. Some women, especially those with more severe cases of pelvic organ prolapse, may experience:

  • Bulge in the vaginal area
  • Feeling like something is "falling out"
  • Pressure or lower back pain
  • Leaking urine or urinary incontinence
  • Difficulty in urinating
  • Discomfort during sexual intercourse
  • Difficulty having a bowel movement
  • Fecal incontinence

These symptoms can influence important aspects of a woman's life, from her ability to perform daily activities to her self-image and sense of control.

About Pelvic Organ Prolapse

What are the risk factors?

Many women suffer in silence and embarrassment, not realizing that these are common problems that can be effectively treated.

Some risk factors for prolapse include:

  • Pregnancy
  • Vaginal delivery
  • Hysterectomy
  • Obesity
  • Chronic cough
  • Chronic straining/ constipation
  • Repetitive heavy lifting
  • Pelvic fractures or trauma
  • Increasing age
  • Genetics

About Pelvic Organ Prolapse

Diagnosis

Pelvic organ prolapse may only be diagnosed by a health care professional skilled in performing pelvic exams. During a pelvic exam you may be asked to strain, contract or tighten the pelvic floor muscles.

Many women with prolapse don't go to their health care professional because they are embarrassed or afraid of what they might find. Before you seek help, it may be useful to make a list of symptoms or unusual things you've been feeling and questions you may have. Remember, prolapse is very common among women of all ages. Don't be embarrassed. Get help and feel better.

Are there different types of prolapse?

Yes, there are. Each of the following types of prolapse deals with a different pelvic organ that is affected by the weakening of pelvic floor muscles.

Cystocele

Cystocele Diagram
Cystocele
A cystocele refers to a protrusion of the bladder against the front wall of the vagina.
click here to enlarge

Cystocele (bladder prolapse, pronounced sis-to-seal) refers to a protrusion or jutting of the bladder against the vagina. Women with a cystocele may feel vaginal discomfort or pain, and may experience some leaking of urine (incontinence) or difficulty/ability to urinate. Some women with cystocele may not be able to completely empty their bladders and may need to push the bulge back into the vagina in order to urinate.

Rectocele

Rectocele Diagram
Rectocele
A rectocele is a bulge of the rectum pressing against the back wall of the vagina.
click here to enlarge

Rectocele (pronounced rek-toe-seal) refers to a bulge of the rectum against the back wall of the vagina. Women with a rectocele may feel vaginal pressure, constipation, or may have difficulty emptying their bowels. Some women with rectocele need to press down on the bulge in order to have a bowel movement.

Enterocele

Enterocele Diagram
Enterocele
An enterocele refers to a bulge (hernia) of the small intestine pressing against the back wall of the vagina near the cervix.
click here to enlarge

Enterocele (pronounced enter-o-seal) refers to a bulge of the small intestine against the backwall of the vagina. Women with an enterocele may feel pelvic pressure, lower backache that worsens throughout the day and is relieved by lying down. Some women with enteroceles may need to press down on the bulge in order to have a bowel movement.

Vaginal Vault Prolapse

Vaginal Vault Prolapse Diagram
Vaginal Vault Prolapse
A vaginal vault prolapse is a weakening at the top of the vagina that causes the vagina to start to fold onto itself moving towards the opening of the vagina.
click here to enlarge

Vaginal vault prolapse refers to a weakening at the top of the vagina that causes the vagina to start to fold onto itself, moving towards the opening of the vagina. Women with vaginal vault prolapse may feel pelvic or vaginal pressure, may have difficulty emptying their bladder or moving their bowels. They may also have pain or discomfort when standing for prolonged periods. This discomfort is relieved by lying down.

Uterine Prolapse

Uterine Prolapse Diagram
Uterine Prolapse
A uterine prolapse is the downward movement of the cervix or neck of the uterus into the vagina.
click here to enlarge

Uterine prolapse refers to a downward movement of the cervix or neck of the uterus into the vagina. It may occur when the pelvic muscles have weakened and the vaginal opening has widened. Women with uterine prolapse may feel discomfort or pressure in the pelvic or vaginal area and may have bloodstained vaginal discharge. Some women may also have lower back pain/discomfort that worsens during the day and is relieved by lying down.

About Pelvic Organ Prolapse

Treatment Options

Treatment of pelvic organ prolapse may be accomplished through surgery or by nonsurgical methods.

One nonsurgical way to treat pelvic organ prolapse is with the Colpexin Sphere. Colpexin is an intravaginal device designed to enhance the performance of pelvic floor muscle exercises. Only your health care professional can decide what treatment is best for you.

Prolapse can affect many areas of a women's life, from her ability to perform daily activities to her self-image and sense of control.

About Pelvic Floor Muscle Weakness

Signs and Symptoms

Many women with pelvic organ prolapse also have pelvic floor muscle weakness. Symptoms are often the same. Some women do not experience any symptoms, but others may experience one or more of the following:

  • Pressure or lower back pain
  • Leaking urine or urinary incontinence
  • Difficulty in urinating
  • Discomfort during sexual intercourse
  • Difficulty having a bowel movement
  • Inability to control their bowels

About Pelvic Floor Muscle Weakness

Stress Urinary Incontinence

Stress urinary incontinence (SUI) is an involuntary leaking of urine when coughing, sneezing, laughing, jumping, or lifting heavy objects. It can result from weakened pelvic floor muscles that support the bladder and urethra and commonly occurs with pelvic organ prolapse. Women are often embarrassed by these symptoms or are unaware that there are treatment options. With as many as 50% of women reporting occasional leaking of urine, evaluation for weakened pelvic floor muscles is an important component of any pelvic exam.

About Pelvic Floor Muscle Weakness

Pelvic Floor Muscle Exercises
and the Colpexin Sphere

Pelvic floor muscle exercises are an important part of your treatment regimen. The pelvic floor muscles (PFM) are a very important muscle group for women—they help support the pelvic organs (the bladder, uterus, and colon), assist in stopping and starting the flow of urine or the passage of gas or stool, and aid in sexual satisfaction. Attached to the pelvic bones, PFM are located at the bottom of your pelvis and form a funnel that spans the width and breadth of the pelvis. When contracted, a deep feeling of tension and firmness is sensed, the muscles move upward, and the openings of the vagina and anus close.

PFM Exercise Program with Colpexin
To begin, empty your bladder and lie on your back on a flat surface with your Colpexin Sphere in place. Keep your knees bent and apart and your head elevated and supported with several pillows. Remember, doing your exercises with the Colpexin Sphere in place will allow you to be sure you are using the right muscle group.

How to perform pelvic floor muscle exercises with Colpexin

  1. Contract or tighten the muscles around the vaginal opening and feel for a lifting of the Colpexin Sphere and closure of the vaginal opening. Locate the string on your Colpexin Sphere and gently pull on it so you can feel that the sphere is in the correct position, above the PFM. Now relax your muscles.
  2. Perform the PFM contraction (feel for lifting of the Colpexin Sphere and closure of the vaginal opening).
  3. Initially, you may only be able to hold each contraction for 3-5 seconds, relaxing for 3-5 seconds for up to 5 repetitions. As you get stronger, you can extend the time, holding the contraction for 5-8 seconds for 8 repetitions. Your goal is to reach 10-second contractions for 10 repetitions. Remember to always relax the PFM for an equal amount of time between contractions.
  4. Do these exercises two times a day.

A Few Helpful Hints...

The quality of the exercises is more important than the number you perform or the seconds you are able to hold each contraction. As with all exercise, you will build strength over time as you follow your treatment regimen.

Avoid straining, holding your breath, or using your buttock muscles while you exercise the PFM. Counting out loud can help prevent this from happening. If you still notice that you use your buttock muscles or hold your breath, you are probably contracting your muscles incorrectly. Review your exercise instructions and try again. If the problem continues, notify your health care provider for more instructions.

As your strength continues to improve, you may want to challenge your muscles further by gently tugging on the string while tightening your PFM. Be sure not to pull so hard as to cause the Colpexin Sphere to actually come out while exercising. If the sphere does come out when you add resistance, just reinsert it according to the directions and return to doing the exercises without adding resistance (pulling on the string).

Pelvic floor muscle exercises are a very important part of your treatment, so try to incorporate these exercises into your daily routine. For example, if you wear your sphere only during the day, try doing your exercises once in the morning after inserting the Colpexin Sphere and once in the evening before you remove your sphere. Make it a habit like brushing your teeth and you will be less likely to forget.



     
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OSCAR A. AGUIRRE, MD, FACOG

Dr. Aguirre
Dr. Aguirre is the Director of Aguirre Specialty Care, The Center for Female Pelvic Medicine. Dr. Aguirre is also a member of the Laser Vaginal Rejuvenation Institute of America.
The Laser Vaginal Rejuvenation Institute of America is founded and directed by Dr. David L. Matlock.

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