Author Archives: scott

Ovarian Cysts

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Ovarian cysts are one of the most common reasons for a women to visit a gynecologist. Many are benign and self-limited. Others require more evaluation to rule out the possibility of a neoplasm. Neoplasm means new growth, which can be, and often is, benign. Malignant neoplasms of the ovary do occur however making the evaluation of ovarian cysts important in early detection of ovarian cancer.

I have created an Overview of Ovarian Cysts complete with images. There is also an external video that details ovarian cysts.

Please share any feedback.

Mirena IUD

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The Mirena IUD

 

is an extremely effective method of birth control. It is a long term (5 years) reversible method with a quick return to fertility. One of its “side effects” is lighter or absent periods. This effect is so pronounced that the company (Bayer) received FDA approval for use of Mirena for the treatment of menorrhagia (heavy menstrual bleeding).

One study in England demonstrated that half of women waiting for a hysterectomy cancelled the surgery after placement of the Mirena to control menorrhagia.

As far as contraceptive efficacy, Mirena is one of the most effective reversible methods of birth control available. The Mirena IUD is 99.9 percent effective. This means that less than one out of every 100 women who use Mirena will become pregnant in one year. 

Of special caution: Most pregnancies happen to Mirena users when their IUDs slide out without them realizing it. This is uncommon and most likely to happen during the first month.  Even though the chance of pregnancy while an IUD is in place is extremely low, if it does happen, you should have the IUD removed as soon as you are aware that you’re pregnant.

The Mirena device costs about $710 retail when ordered in the United States. Your health insurance may cover this but deductibles/coinsurance would apply. Some patients order the device from Canada at a cost of about $210. It will be mailed to their home. They can bring it to the office to be inserted by their gynecologist. You should know that NONE of the Mirena devices are manufactured in the United States; all are imported from Finland.

New In-office Treatment for Urinary Incontinence – Renessa

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We now have a  non-surgical approach to treat stress urinary incontinence (SUI). The Renessa treatment by Novasys uses a small probe which a physician passes through the urethra. The treatment can be performed in the convenience of a physician’s office or other outpatient setting. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. 

 

The Renessa procedure uses radiofrequency energy (RF) to generate controlled heat at low temperatures in tissue targets within the lower urinary tract. The heat denatures collagen in the tissue at multiple small treatment sites. Upon healing, the treated tissue is firmer, increasing resistance to involuntary leakage at times of heightened intra-abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating SUI episodes. 

RF has been routinely used by physicians in the treatment of numerous conditions for many decades. At higher temperatures than those generated by the Renessa System, RF energy can cut and/or ablate tissue for the treatment of upper airway disorders, cardiac arrhythmias, benign prostate hyperplasia, excessive uterine bleeding (menorrhagia) and other conditions. Low temperature RF is used to treat luminal disorders such as gastroesophageal reflux disease, fecal incontinence, and now, female stress urinary incontinence. 

 

Benefits of the Renessa treatment include:

  • Non-surgical, in-office procedure
  • Single treatment
  • No incisions, bandages, or dressings
  • Excellent safety profile, well tolerated
  • Can be performed using local anesthesia + oral sedation
  • Rapid recovery with minimal limitationsIn a U.S. clinical study, the majority of women who underwent the Renessa treatment experienced a significant improvement in quality of life measures such as reduced daily leak episodes and reduced or eliminated pad use. Key 12 month clinical outcomes in Renessa patients are as follows:  
  • 76% of patients reported a reduction in incontinence episodes;
  • 59% of women reduced their daily episodes by at least half;
  • 58% of women eliminated the need for pads;
  • More than a third of the women treated were completely dry.
  • The Renessa? TreatmentThe Renessa Treatment:  Once the patient has received the appropriate anesthetic (either local anesthesia or conscious sedation), her physician passes the Renessa probe through the urethral opening and the urethra into the bladder. With the end of the probe positioned within the bladder, a small balloon is inflated to maintain the probe in its proper position during treatment. With the probe in place, radiofrequency energy is delivered from a compact RF generator to four small needles which are deployed from the probe into the tissue of the bladder neck and upper urethra. No visualization of the treatment site is required. RF is delivered for 60 seconds, heating small areas of tissue around the needle tips to a temperature at which collagen undergoes a structural change (denatures). The probe is located and repositioned using a series of simple maneuvers and RF is delivered for 60 seconds a total of nine (9) times, thus denaturing collagen at 36 tissue sites.

    • Following the Renessa procedure, patients can return to most normal daily activities the same or the next day with minimal limitations. 

    About Stress Urinary Incontinence  

    Stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting 15 million women in the United States alone. SUI is the involuntary leakage of urine which occurs during periods of increased intra-abdominal pressure (?stress?). SUI occurs with laughing, sneezing, coughing, exercise, lifting, and other activities. The primary cause of SUI is inadequate support of the bladder, resulting in bladder outlet hypermobility. SUI affects women of all ages, including approximately 25% of women age 30-59 years, particularly those who have delivered at least one baby vaginally. 

    While not a life threatening disorder, SUI diminishes a woman’s quality of life, often limiting her professional, social, sexual, and recreational activities. A variety of therapeutic options are available to treat women with SUI. These approaches are broadly divided into non-surgical and surgical treatments, and each category has specific benefits and risks. The SUI Therapeutic Spectrum shown below summarizes where the various non-surgical and surgical treatments currently available fall along a continuum of invasiveness. 

    There are several non-surgical approaches to the treatment of SUI; however, these often require multiple and repeated treatments over weeks and months to achieve and maintain effectiveness. Some non-surgical treatments, such as urinary plugs and vaginal pessaries, mechanically block urine leakage. Other therapies, such as Kegel exercises, biofeedback, physical therapy, and pelvic floor electrical stimulation, attempt to strengthen the pelvic floor muscles. These strengthening approaches have limited effectiveness and patient compliance problems. Bulking agents (which are injected into the urethra to partially obstruct the flow of urine) are not approved by the FDA for the treatment of SUI due to hypermobility, but are nonetheless used by some physicians in these patients. Effectiveness is limited, multiple treatments are often required and some agents are associated with a higher incidence of adverse events than other treatment options. While the various surgical treatments have demonstrated adequate effectiveness, they all pose greater risk to the patient than the non-surgical treatments. The most common type of surgical treatments are referred to as sling procedures because they involve insertion of an implant (known as a ?sling?) to support the bladder and urethra. These treatments range from traditional invasive, open surgical procedures to the more recently introduced, less invasive laparoscopic or percutaneous sling insertion techniques. All can result in post-operative pain, prolonged post-operative recovery, and significant costs. Furthermore, some women who have undergone a surgical treatment report continued leaking. Surveys have shown that many women with SUI are not interested in a surgical therapy.

    Novasure Procedure

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    Steps of the NovaSure procedure:

      The NovaSure electrode array expands to conform to the contours of each patient’s uterine cavity.
      The Cavity Integrity Assessment is performed using a small amount of CO2.
      NovaSure endometrial ablation delivers RF energy until the ablation is complete in approximately 90 seconds.
      The electrode array is retracted for easy removal, leaving the uterine lining desiccated down to the superficial myometrium.

    In-office Permanent Treatment for Menorrhagia (heavy menstrual bleeding)

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    Heavy menstrual bleeding or menorrhagia, affects  one out of every 3-5 women. Many women suffer needlessly hoping that menopause will come soon.  Now there is an office procedure that will permanently decrease their menstrual flow and may even eliminate it altogether without affecting their hormone levels. There are no incisions, meaning a quick recuperation and return to normal activities.

    The procedure is called an “Endometrial Ablation”.  This is one of the latest tools for the gynecologist that has dramatically reduced the number of hysterectomies previously performed for menorrhagia. Nowadays many women do not want their uterus removed simply to control heavy menstrual bleeding. This procedure specifically targets and ablates (destroys) the endometrium or lining portion of the uterus which is responsible for the monthly menstrual bleeding. The myometrium (muscle portion of the uterus), cervix, tubes, and ovaries are neither removed nor disturbed by this procedure. (See uterus diagram).

    To be eligible, women must have completed their childbearing; have a normal endometrial biopsy; and a uterus of sufficient size/architecture to undergo the procedure. (Women with very large fibroids that distort the endometrial cavity do not have the same rates of success although smaller fibroids are often amenable to the procedure).

    The most common procedure performed is the NovaSure type ablation. This uses an expandable array to ablate the endometrium. It is microprocessor controlled to ensure uniform treatment of the endometrium and will shut itself off when the tissue resistance indicates a complete treatment. Treatment time averages 90 seconds, (although equipment set up will take longer).

    Women are generally given pre-operative sedation with Valium and Vicodin, an injection of Toradol at the office; as well as a paracervical anesthestic. (This involves using local anesthetics lidocaine and bupivicaine in the paracervical tissues).  Because of the sedation, it is recommended that a friend or family member be available to drive.

    While no treatment is perfect, endometrial ablation offers 95% improvement with up to 40% of women achieving amenorrhea (no periods at all). The minimal investment in downtime and recuperation is well worth the potential life changing reward of freedom from heavy menstrual bleeding.

    Tranexamic Acid for Menorrhagia Significantly Improves Quality of Life

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    May 28, 2010 (San Francisco, California) — Women who took tranexamic acid (Lysteda, Ferring Pharmaceuticals) for heavy menstrual bleeding experienced significant improvements in quality of life after 3 cycles — and were more able to participate in social, leisure, physical, and social activities after taking the medication, said researchers here at the American Congress of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting.

    In several studies unveiled at the meeting, more than 70% of women who took the highest dose of tranexamic acid (3.9 g/day) responded to the medication.

    Xanodyne Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for the drug in late November 2009. Ferring Pharmaceuticals acquired Lysteda from Xanodyne Pharmaceuticals on May 10, 2010.

    Tranexamic acid is the first nonhormonal product approved by the FDA for use in treating menorrhagia. It works by inhibiting fibrinolysis. “If you can block that activity within the endometrium, clots remain for a longer time, are more stable, and women bleed less,” said researcher Andrea Lukes, MD, from the Carolina Women’s Research and Wellness Center in Durham, North Carolina.

    Tranexamic acid was first approved by the FDA in 1986 as an injection under the brand name Cyklokapron and has been used to prevent bleeding in patients with hemophilia after tooth extraction. Lysteda is a new oral formulation of tranexamic acid.

    As many as 25% of women (3 million women of reproductive age) in the United States experience menorrhagia, often when there is no underlying medical condition. As part of its requirements for the approval of tranexamic acid, the FDA asked that clinical trials demonstrate a significant improvement in quality of life for women who take the drug, and that women perceive the drug as beneficial, Dr. Lukes noted.

    In a multicenter double-blind placebo-controlled study, 294 women 18 to 49 years of age with heavy menstrual bleeding (defined as menstrual blood loss of greater than 80 mL per cycle averaged over 2 cycles) received a dose of 3.9 g/day of tranexamic acid, 1.9 g/day of tranexamic acid, or placebo for up to 5 days per cycle for 3 menstrual periods.

    The Menorrhagia Impact Questionnaire (MIQ) was administered at baseline and after 3 treatment cycles. The MIQ assesses limitations in physical, social, and leisure activities, reductions in the ability to work inside or outside the home, and perceived mean blood loss reduction. Most of the women who participated in the study had experienced heavy menstrual periods for a significant length of time (mean, 10 to 12 years), Dr. Lukes said.

    When the women were asked on the MIQ to rate the extent to which their menstrual bleeding limited their work outside and inside the home, on a scale of 1 to 5 (with 1 being “not at all” and 5 being “extremely” limiting), women taking tranexamic acid experienced a 1-point reduction in their restrictions, which was significantly more than those in the placebo group (P < .0001). When asked about how much their menstrual bleeding limited their social and leisure activities, women taking tranexamic acid experienced a similar drop in limitations after being on the drug for 3 cycles. The effect on quality of life was dose-dependent, however, with the greatest benefit seen in those receiving 3.9 g/day. This dose is now considered to be the standard dose for menorrhagia, Dr. Lukes said.

    The researchers concluded that the MIQ is an important instrument for assessing treatments for heavy menstrual bleeding. “Future studies need to address women’s perspectives on these medications,” Dr. Lukes said.

    “I think it’s important that both women and clinicians be aware of yet another option in terms of management of abnormal and heavy menstrual bleeding,” said Paula Hillard, MD, chief of the Division of Gynecologic Specialties in the Department of Obstetrics and Gynecology at Stanford University School of Medicine in California.

    Dr. Hillard noted that a number of hormonal options, such as birth control pills and the progesterone-containing Intrauterine device (IUD), are quite useful in controlling menorrhagia. Hormonal medications can have adverse effects; however, the rates of significant adverse effects are actually quite low, especially for the progesterone IUD, she said. The most common adverse effects for women who took tranexamic acid in the studies presented at ACOG were headache, abdominal discomfort, menstrual discomfort, diarrhea, and nausea.

    The combination of tranexamic acid and hormonal contraceptives can increase the risk for blood clots, stroke, and heart attack. However, for women who can’t take hormonal medications, such as those with migraines who are at increased risk of stroke from estrogen medications, tranexamic acid might be one alternative, Dr. Hillard said.

    “It’s another option and options are good for management of a problem that can truly be life-changing for many women,” she said.

    The studies were funded by Ferring Pharmaceuticals, Inc. Dr. Lukes reports receiving research support from Xanodyne, Interlace Medical, Merck, Bayer, Hologic, and Duramed; and speaker/consultant fees from Xanodyne, Bayer, Interlace Medical, Myriad, and Boehringer Ingelheim. Dr. Hillard has disclosed no relevant financial relationships.

    American Congress of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting: Presented May 17 and May 18, 2010.

    What is a pessary?

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    A pessary is a device typically made out of siliconized rubber that is placed in the vagina to elevate the bladder or uterus to treat prolapse and/or incontinence. (See image) There are many sizes, shapes and configurations. Common forms are the ring, ring with support, and ring with incontinence knob.

    Pelvic Prolapse Animation

    Placement of a pessary often produces dramatic and instant results. Compared with surgery there is no significant risk  or recuperation involved. The results are, however, variable. The pessary needs to be maintained with periodic cleaning and examinations to ensure that there are no erosions. Some women are able to clean and re-insert it themselves; others come in to the office every 2-3 months.

    There are some risks to using it: 1.Erosion or ulceration of the vagina can happen, particularly if the pessary is left unattended for long periods of time. 2. Expulsion, often into the toilet during straining. 3. Decreased efficacy over time, a larger pessary may be necessary or it may cease to provide the same relief of symptoms, particularly incontinence.

    For those whom a  pessary has failed, surgical correction of prolapse remains an option.

    Stop having heavy periods (menorrhagia)

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    I am continually amazed at how many women in my practice describe their cycles as “normal”. While it may be their usual pattern to bleed for 5-7 days and need to curtail their work or social lives, it is far from normal. Most women who seek treatment are at the severest end of the spectrum with anemia and “accidents” where both a tampon and maxi-pad have failed.

    Estimates are that 1 in 3 women suffer from heavy periods or menorrhagia. Menorrhagia by the way is derived from the latin meaning “heavy” periods. Variations include metrorrhagia (frequent periods) or menometrorrhagia (frequent heavy periods). Many women are unaware that effective reversible and permanent treatments exist.

    Some treatments are permanent and extremely effective for those who have completed their childbearing ; endometrial ablation being the most effective/least invasive. Reversible treatments involve a variety of medical therapies, ranging from regular use of NSAID’s (non-steroidal anti-inflammatory drugs), hormonal management,and now finally a drug that stabilizes clots and specifically has been shown to reduce menstrual bleeding called Lysteda. Lysteda(brand name) or Tranexamic Acid (generic name) is a non-hormonal reversible treatment NOW available in the United States for treatment of menorrhagia. We now have another tool in our chest to treat menorrhagia. 

    While the latest addition of Lysteda increases the number of treatment options, what is really needed is greater recognition of heavy menstrual bleeding as a problem. Probably the most frequent comment I hear in my practice is a women asking, “Why didn’t I do this sooner?”