YOU and Uterine fibroids - Zuellig Pharma · PDF file04 You and uterine fibroids_ 05 What are uterine fibroids? How common are they? Uterine fibroids are unusual growths found in the

YOU and UterinefibroidsA guide for women

who have been diagnosed with uterine fibroids

This material provides important information about uterine fibroids. It will help you to understand your condition and your treatment.Please speak to your doctor or pharmacist if you have any additional queries.

[ Introduction ]

Contents

What are uterine fibroids?

How common are they?

Are there different types of uterine fibroids?

What are the symptoms?

What types of treatments can be used to treat fibroids?

Useful resources

Tools to track your treatment progress

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Uterine fibroids

Are unusual growths found in the muscle wall of the uterus (the medical term for your womb)

Can cause heavy and painful periods and have a negative impact on your day to day life

Respond to changes in progesterone levels(a type of natural hormone)

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What are uterine fibroids? How common are they?

Uterine fibroids are unusual growths found in the muscle of the uterus (the medical term for your womb). They grow very slowly and over time can become very large. When this happens, they can cause pain and discomfort and (unsurprisingly) have a negative impact on your day to day life. Sometimes you may hear them referred to as ‘tumors’, which may sound alarming, but rest assured uterine fibroids are not a type of cancer. ‘Tumor’ simply means an unexpected growth.

Uterine fibroids are very common: more than 40% of women will develop them at some point in their lives. Typically, they affect women of childbearing age (usually over the age of 35). However, the causes of uterine fibroids are not fully understood. What we do know is that they respond to changes in progesterone levels in your body – a naturally occurring hormone. Treatments that target progesterone, like selective progesterone-receptor modulators (SPRMs), can help control the growth of uterine fibroids and the symptoms that they can cause.


Are there different types of uterine fibroids?

There are many different types of uterine fibroids. Each type is found in a different location in the uterus, and a combination of different types can also occur:

Illustration shows different types of uterine fibroids

Intramural fibroids are found within the wall of the uterus and are the most common type.

Subserosal fibroids are found on the outer wall of the uterus. Sometimes they are attached by a thin stalk called a peduncle.* These types are called ‘pedunculated subserosal fibroids’ and can cause a lot of pain because they can twist around or compress other organs in the stomach.

Submucosal fibroids grow on the inner wall of the uterus (endometrium). Because they push into the uterus, they can cause it to change in shape and size. Submucosal fibroids can also be pedunculated.

Cervical fibroids are found in the ‘neck’ (cervix) of the uterus.

Intraligamentous fibroids grow on the ligaments that hold the uterus in place.

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ARE THERE DIFFERENT TYPES OF UTERINE FIBROIDS?

There are many different types of uterine fibroids. Each type

is found in a different location in the uterus, and a combination

of different types can also occur:

Intramural fibroids are found within the wall of the uterus

and are the most common type

Subserosal fibroids are found on the outer wall of the

uterus. Sometimes they are attached by a thin stalk called

a peduncle. These types are called ‘pedunculated subserosal

fibroids’ and can cause a lot of pain because they can twist

around or compress other organs in the stomach

Submucosal fibroids grow on the inner wall of the uterus

(endometrium). Because they push into the uterus, they can

cause it to change in shape and size. Submucosal fibroids

can also be pedunculated

Cervical fibroids are found in the ‘neck’ (cervix) of the uterus

Intraligamentous fibroids grow on the ligaments that

hold the uterus in place

Intramural fibroids

Pedunculatedsubmucosal

fibroid

Submucosalfibroid

Intraligamentousfibroid

Endometrium

Cervix

Fallopian tube

Uterus wall

Subserosalfibroids

Pedunculatedsubserosal

fibroid

Cervicalfibroid

Illustration shows different types of uterine fibroids

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* A peduncle is an elongated stalk of tissue. In medicine, a mass such as a tumor is said to be pedunculated if it is supported by a peduncle.


Medications

What are the symptoms?


There's no single best approach to uterine fibroid treatment — many treatment options exist. If you have symptoms, talk with your doctor about options for symptom relief.

Medications for uterine fibroids target hormones that regulate your menstrual cycle, treating symptoms such as heavy menstrual bleeding and pelvic pressure. They don't eliminate fibroids, but may shrink them. These medications include:

Uterine fibroids may cause symptoms such as:

Heavy, painful periods that last a long time

Anemia (a lack of red blood cells) due to heavy periods, causing extreme tiredness

Bleeding between periods

A feeling of pressure in the bladder and stomach

Needing to go to the toilet more often than usual

Discomfort while going to the toilet

A visible increase in the size of the stomach

Constipation

Pain during sex

Complications during pregnancy, such as an increased risk of miscarriage and/or problems during labor

Difficulty getting pregnant

General fatigue

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Gonadotropin-releasing hormone (GnRH) agonists Medications called GnRH agonists treat fibroids by blocking the production of estrogen and progesterone, putting you into a temporary postmenopausal state. As a result, menstruation stops, fibroids shrink and anemia often improves. Your doctor may prescribe a GnRH agonist to shrink the size of your fibroids before a planned surgery. Many women have significant hot flushes while using GnRH agonists. GnRH agonists are typically used for no more than three to six months because symptoms return when the medication is stopped and long-term use can cause bone loss.

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Selective progesterone-receptor modulators (SPRMs)SPRMs are a new class of oral medications that significantly decreases the size of the fibroids found in your uterus. They also significantly reduce the excessive menstrual bleeding which leads to quality of life being restored.

Progestin-releasing intrauterine device (IUD)A progestin-releasing IUD can relieve heavy bleeding caused by fibroids. A progestin-releasing IUD provides symptom relief only and doesn't shrink fibroids or make them disappear.

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A non-invasive treatment option for uterine fibroids that preserves your uterus, requires no incision and is done on an outpatient basis.

Performed while you're inside an MRI scanner equipped with a high-energy ultrasound transducer for treatment. The images give your doctor the precise location of the uterine fibroids. When the location of the fibroid is targeted, the ultrasound transducer focuses sound waves (sonications) into the fibroid to heat and destroy small areas of fibroid tissue.

Newer technology, so researchers are learning more about the long-term safety and effectiveness. But so far data collected show that FUS for uterine fibroids is safe and effective.

Non-invasive procedureMRI-guided focused ultrasound surgery (FUS) is:

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Uterine artery embolization Small particles (embolic agents) are injected into the arteries supplying the uterus, cutting off blood flow to fibroids, causing them to shrink and die. This technique can be effective in shrinking fibroids and relieving the symptoms they cause. Complications may occur if the blood supply to your ovaries or other organs is compromised.

Myolysis In this laparoscopic procedure, an electric current or laser destroys the fibroids and shrinks the blood vessels that feed them. A similar procedure called cryomyolysis freezes the fibroids. Myolysis is not used often. Another version of this procedure, radiofrequency ablation, is being studied.

Laparoscopic or robotic myomectomy In a myomectomy, your doctor removes the fibroids, leaving the uterus in place. If the fibroids are small and few in number, you and your doctor may consider for a laparoscopic or robotic procedure, which uses slender instruments inserted through small incisions in your abdomen to remove the fibroids from your uterus. Your doctor views your abdominal area on a monitor using a small camera attached to one of the instruments. Robotic myomectomy gives your doctor a magnified, 3-D view of your uterus, offering more precision, flexibility and dexterity than is possible using some other techniques.

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Hysteroscopic myomectomy This procedure may be an option if the fibroids are contained inside the uterus (submucosal). Your doctor accesses and removes fibroids using instruments inserted through your vagina and cervix into your uterus.

Endometrial ablation and resection of submucosal fibroidsThis treatment, performed with a specialized instrument inserted into your uterus, uses heat, microwave energy, hot water or electric current to destroy the lining of your uterus, either ending menstruation or reducing your menstrual flow. Typically, endometrial ablation is effective in stopping abnormal bleeding. Submucosal fibroids can be removed at the time of hysteroscopy for endometrial ablation, but this doesn't affect fibroids outside the interior lining of the uterus.

Minimally invasive proceduresCertain procedures can destroy uterine fibroids without actually removing them through surgery. They include:

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Abdominal myomectomy If you have multiple fibroids, very large fibroids or very deep fibroids, your doctor may use an open abdominal surgical procedure to remove the fibroids. Many women who are told that hysterectomy is their only option can have an abdominal myomectomy instead.

Hysterectomy This surgery — the removal of the uterus — remains the only proven permanent solution for uterine fibroids. But hysterectomy is a major surgery. It ends your ability to bear children. And if you also elect to have your ovaries removed, it brings on menopause and the question of whether you'll take hormone replacement therapy. Most women with uterine fibroids can choose to keep their ovaries.

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Women’s Healthwww.womens-health.co.uk/fibroids.asp

NHS Choiceswww.nhs.uk/conditions/Fibroids/Pages/Introduction.aspx

British Fibroid Trustwww.britishfibroidtrust.org.uk

Mayo Clinicwww.mayoclinic.org/

Helthlinewww.healthline.com/health/uterine-fibroids

WebMDwww.webmd.com/women/uterine-fibroids/uterine-fibroids

MedicinNETwww.medicinenet.com/uterine_fibroids/article.htm

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Traditional surgical proceduresOptions for traditional surgical procedures include:

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Useful resourcesWhat types of treatments can be used to treat fibroids?


Visual analogue scale (VAS) for assessment

Example of a completed Pictorial Blood Assessment Chart (PBAC) showing a score of 320

Pictorial Blood Assessment Chart(PBAC)

Visual Analogue Scale(VAS)

The pictorial blood assessment chart (PBAC) consists of a series of diagrams representing lightly, moderately and heavily soiled towels and tampons. The numbers at the top of the chart represent the day of menstruation. The woman is instructed to insert a mark in the appropriate box at the time each towel and/or tampon is discarded and if sufficient they are counted in groups of five. Passage of clots (size equated with the size of different coins) and episodes of flooding are also recorded.The woman is given the chart to complete with her next menstrual period, with clear instructions and an explanation of how it should be used. After completion, the woman returns the chart by post (stamped addressed envelops are provided) or during her next appointment to the clinic.

Using a visual analogue scale (VAS), patients are instructed to point to the position on the line between faces to indicate how much pain they feel. In this system the total scores range from 0 to 100 based on the distance in millimeters from the left end bar to the mark made on the 10 cm line anchored by happy to sad faces, with a higher score indicating more severe pain.

[ Choose a Number from 0 to 10 That Best Describes Your Pain]

[ ASK PATIENTS ABOUT THEIR PAIN ]

INTENSITY - LOCATION - ONSET - DURATION - VARIATION - QUALITY

Large clots/flooding

Small clots/flooding

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Tools to track your treatment progress

No Hurt

No Pain

DistressingPain

UnbearablePain

HurtsLittle More

HurtsWhole Lot

HurtsLittle Bit

HurtsEven More

Worst

Visual analogue scale

"Faces” pain rating scale

PEARL I web appendix

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Supplementary Figure 1. Example of a completed PBAC showing a score of 320

(equivalent to a menstrual blood loss of approximately 250 mLs).

The investigators used imaging to assess the likely contribution of fibroids to the

symptoms of menorrhagia, and, in nearly all cases, ultrasound and MRI

demonstrated the presence of at least one submucosal or intramural myoma

distorting the intrauterine cavity.


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Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire

During the previous 3 months, how distressed were you by…

Not at all

A little bit

Some-what

A great deal

A very great deal

1. Heavy bleeding during your menstrual period 1 2 3 4 5

2. Passing blood clots during your menstrual period 1 2 3 4 5

3. Fluctuation in the duration of your menstrual period compared to your previous cycle 1

2 3 4 5

4. Fluctuation in the length of your monthly cycle compared to your previous cycles 1 2 3 4 5

5. Feeling tightness or pressure in your pelvic area 1 2 3 4 5

6. Frequent urination during the daytime hours 1 2 3 4 5

7. Frequent nighttime urination1 2 3 4 5

8. Feeling fatigued1 2 3 4 5

During the previous 3 months, how often have your symptoms related to uterine fibroids…

None of the time

A little

of the time

Some of the time

Most of the time

All of the time

9. Made you feel anxious about the unpredictable onset or duration of your periods? 1 2 3 4 5

10. Made you anxious about traveling? 1 2 3 4 5

11. Interfered with your physical activities? 1 2 3 4 5

12. Caused you to feel tired or worn out? 1 2 3 4 5

13. Made you decrease the amount of time you spent on exercise or other physical activities? 1 2 3 4 5

14. Made you feel as if you are not in control of your life? 1 2 3 4 5

15. Made you concerned about soiling underclothes? 1 2 3 4 5

16. Made you feel less productive?1 2 3 4 5

17. Caused you to feel drowsy or sleepy during the day? 1 2 3 4 5

18. Made you feel self-conscious of weight gain? 1 2 3 4 5

19. Made you feel that it was difficult to carry out your usual activities? 1 2 3 4 5

20. Interfered with your social activities? 1 2 3 4 5

21. Made you feel conscious about the size and appearance of your stomach? 1 2 3 4 5

22. Made you concerned about soiling bed linen? 1 2 3 4 5

Uterine Fibroid Symptom and Quality of Life (UFS - QOL) questionnaire

The UFS-QOL questionnaire was developed from focus groups of women with uterine fibroids. The final questionnaire consists of an eight-item symptom severity scale and 29 health-related QOL (HRQOL) questions, which comprise six subscales: concern, activities, energy/mood, control, self-consciousness, and sexual function.

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Uterine fibroid symptom and health-related quality of life questionnaire

• Pt. Initials :

• Date :

• Pt. ID :

Listed below are symptoms experienced by women who have uterine fibroids. Please consider each symptoms as it relates to your uterine fibroids or menstrual cycle. Each question asks how much distress you have experienced from each symptom during the previous 3 months.

There are no right or wrong answers. Please be sure to answer every question by checking ( ) the most appropriate box. If a question does not apply to you, please mark "not at all" as a response.

The following questions ask about your feelings and experiences regarding the impact of uterine fibroid symptoms on your life. Please consider each question as it relates to your experiences with uterine fibroids during the previous 3 months.

There are no right or wrong answers. Please be sure to answer every question by checking ( ) the most appropriate box. If the question dose not apply to you, please check ”none of the time” as your option.


During the previous 3 months, how often have your symptoms related to uterine fibroids…

None of the time

A little

of the time

Some of the time

Most of the time

All of the time

23. Made you feel sad, discouraged, or hopeless? 1 2 3 4 5

24. Made you feel down hearted and blue? 1 2 3 4 5

25. Made you feel wiped out?1 2 3 4 5

26. Caused you to be concerned or worried about your health? 1 2 3 4 5

27. Caused you to plan activities more carefully? 1 2 3 4 5

28. Made you feel inconvenienced about always carrying extra pads, tampons, and clothing to avoid accidents?

1 2 3 4 5

29. Caused you embarrassment?1 2 3 4 5

30. Made you feel uncertain about your future? 1 2 3 4 5

31. Made you feel irritable?1 2 3 4 5

32. Made you concerned about soiling outer clothes? 1 2 3 4 5

33. Affected the size of clothing you wear during your periods? 1 2 3 4 5

34. Made you feel that you are not in control of your health? 1 2 3 4 5

35. Made you feel weak as if energy was drained from your body? 1 2 3 4 5

36. Diminished your sexual desire?1 2 3 4 5

37. Caused you to avoid sexual relations? 1 2 3 4 5

Uterine Fibroid Symptom and Quality of Life (UFS - QOL) questionnaire

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References

1. Data on file: HRA.

2. Uterine Fibroids FAQ. American College of Obstetricians and Gynecologists.

3. Vilos GA, et al. The management of uterine leiomyomas. J Obstet Gynaecol Can. 2015;37(2):157–78.

4. Olive DL. Radiological Interventions in Obstetrics and Gynaecology. pp.17-27.

5. Donnez J and Dolmans MM. Uterine fibroid management: from the present to the future. Hum Reprod

Update. 2016 Jul 27 [Epub ahead of print]

6. Donnez J, et al; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery.

N Engl J Med. 2012;366(5):409-20.

7. Lee CA, et al. Inherited Bleeding Disorders in Women. Blackwell Publishing Ltd. 16 Feb 2009.

8. Ghaderi F, et al. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized

clinical trial". Dent Res J (Isfahan). 2013;10(6):790-4.

9. Coyne KS, et al. Validation of the UFS-QOL-hysterectomy questionnaire: modifying an existing measure for

comparative effectiveness research. Value Health. 2012;15(5):674-9.

10. Spies JB, et al. The UFS-QOL, a new disease-specific symptom and health-related quality of life

questionnaire for leiomyomata. Obstet Gynecol. 2002;99(2):290-300.


NOTES NOTES

You and Uterinefibroids

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YOU and Uterine fibroids - Zuellig Pharma · PDF file04 You and uterine fibroids_ 05 What are uterine fibroids? How common are they? Uterine fibroids are unusual growths found in the