Heavy Menstrual Bleeding (HMB) has replaced the old term "menorrhagia". It is not usually practical to accurately measure menstrual fluid volume except in clinical studies, although the more frequent use of menstrual cups recently can allow a more accurate assessment of the volume of bleeding.
HMB is a practical term to describe the effect of the heavy periods on the woman. Do your periods cause you to flood? Do you routinely pass large clots? Do you need double protection with pads and tampons, and flood the bed at night? Are you actually housebound by your bleeding? Does it interfere with your work and enjoyment of life? Have you become fatigued, iron deficient or even anaemic? These are the practical questions that matter to women.
HMB affects women throughout their lives from their teens to their fifties, but fortunately most types are readily treated rather simply, in contrast to days gone by when a high proportion of women would be forced to endure a hysterectomy. In recent years the incidence of hysterectomy has reduced (by about 40% in Australia) thanks to advances in conservative treatments.
Heavy regular periods, especially if it is a lifelong pattern from the time the periods commence, may be due to local abnormalities of bleeding control in the lining of the uterus (endometrium) or due to inherited defects of coagulation such as Von Willebrand's disease. Acquired abnormalities of blood clotting, for instance with medications taken for deep venous thrombosis and heart disease, can also affect the ability of the endometrium to shut down menstrual bleeding.
Anovulatory bleeding usually results in irregular cycles and often occurs at either end of reproductive life and in women with PCOS; the ovaries may be producing oestrogen which causes growth of the uterine lining, but ovulation is impaired and insufficient progesterone is secreted to temper this growth.
Many women will respond to simple treatments such as the oral contraceptive pill, Implanon, Nuvaring, Depo Provera, and the Mirena IUD, with the added benefit of safe and effective contraception. For women who cannot use these methods, non hormonal methods that preserve fertility include Tranexamic Acid and non steroidal anti-inflammatory drugs.
Insertion of the Mirena IUD can often be performed in the clinic. I have performed successful IUD insertions for thousands of women of all ages, including those who have not given birth or have only had caesarean sections, as outpatients. It may be necessary to remain in the clinic for monitoring for 30 minutes or so afterwards, especially if the patient experiences cramping or symptoms of vasovagal stimulation (sweating, faintness) with procedures in the past. These patients should consider having someone to drive for them after the procedure. For most women Mirena insertion is straight forward and involves minimal discomfort but for those who have had difficulties, taking paracetamol and an anti-inflammatory medication such as Naproxen 550 mg 1-2 hours, or Tramadol 50 mg, before the IUD insertion might be helpful. If you experience fainting with blood tests or pain you should let us know this, so that we can plan your visit. Some patients, particularly those who find they have had difficulties with IUD insertions in the past might benefit from using a Penthrox inhaler during the procedure. This inhaler is very safe, provides excellent pain relief, and is available on prescription for less than $60. This can be arranged for you at your visit, if you would prefer it, and we will instruct you on its use before the IUD insertion. You must have someone to drive you home after use of Penthrox.
Women whose HMB does not respond to the methods described above may need further investigation by ultrasound scanning to rule out fibroids, polyps, endometriomas (cysts on the ovary containing endometriosis) and adenomyosis.
Of course any woman with irregular bleeding in between periods, or bleeding after intercourse, needs to have lesions of the cervix and cancer of the uterus excluded. This might require further investigation with a colposcopy.
Some women will need to undergo hysteroscopy to exclude polyps, fibroids and cancer. Often polyps and fibroids substantially inside the cavity of the uterus can be resected with a camera inserted into the cervix, as a day procedure, with no cuts in the body, and minimal down time.
Women who have a normal or only modestly enlarged uterus and who have definitely finished their families, may also be offered the day surgery procedure of Endometrial Ablation; it is not contraceptive so attention must be paid to ensuring some other contraceptive method is used. In addition, endometrial ablation destroys the lining of the uterus, so pregnancy is contraindicated afterwards; it is only suitable for women who have definitely finished their families for good.
Currently I use the Novasure Endometrial Ablation System and I perform this procedure in the Day Surgery Unit of the Wesley Hospital, under a very light anaesthetic, which means you have an Anaesthetic Specialist to care for you during the procedure, and get excellent pain relief, whilst being fit to return home the same day and resume normal activities the day after. I may discuss with you other contraceptive measures including vasectomy, tubal ligation or the Mirena IUD. Please note the ESSURE device for permanent contraception has been withdrawn from the Australian market. If you decide to have a Mirena placed after endometrial ablation, you need to be aware it can occasionally (but certainly not always) be difficult to remove on the couch subsequently, and could require a light anaesthetic so to do. However, for those women for whom the only other alternative is the more invasive procedure of hysterectomy, the addition of Mirena insertion to Endometrial Ablation may be a very acceptable contraceptive option which has the potential to markedly reduce recurrence of heavy bleeding (thanks to the progesterone in the device) whilst they await the onset of natural menopause. In addition the Mirena IUD has been shown to reduce the incidence of polyps, pre cancers and cancers in the uterus, and in women over the age of 45 can provide contraception for up to 10 years. We will discuss all these options fully at your visit, but I am aware that many women want to avoid major surgery such as hysterectomy with its attendant down time and risks, so I am willing to tailor a solution to their problem that suits them individually.
Finally, there will be some women for whom a hysterectomy may be the only solution, especially in the case of very large fibroids or severe adenomyosis. Fortunately, in most cases now it is possible to perform these procedures with laparoscopic surgery which means less risk and downtime to the woman.
Since all women with HMB have different causes, medical issues, and social and work concerns, it is necessary to take an individualistic approach.My belief, supported by evidence from studies, is that we should try the safest and least invasive options first, which are often cheaper as well. First do no harm.
You should remember that any surgical or invasive procedure carries risks. Before proceeding, you should completely familiarise yourself with all the options and risks, and if you are uncertain, seek a second opinion from an appropriately qualified health practitioner.
References for Mirena IUD at the same time as Endometrial Ablation for women wishing to avoid hysterectomy:
(2) Comparison of combined transcervical resection of the endometrium and levonorgestrel-containing intrauterinesystem treatment versus levonorgestrel-containing intrauterine system treatment alone in women with adenomyosis: a prospective clinical trial.Zheng J1, Xia E, Li TC, Sun X.
(3) Combined Endometrial Ablation and Levonorgestrel Intrauterine System Use in Women With Dysmenorrhea and Heavy Menstrual Bleeding: Novel Approach for Challenging Cases.Papadakis EP1, El-Nashar SA1, Laughlin-Tommaso SK1, Shazly SA1, Hopkins MR1, Breitkopf DM1, Famuyide AO2.
(4) An evaluation of the simultaneous use of the levonorgestrel-releasing intrauterine device (LNG-IUS, Mirena®) combined with endometrial ablation in the management of menorrhagia.Vaughan D1, Byrne P. J Obstet Gynaecol. 2012 May;32(4):372-4. doi: 10.3109/01443615.2012.666581.
(5) Longterm menstrual outcomes 5 years post endometrial ablation with concurrent insertion of Levonorgestrel intrauterine device in women seeking treatment for benign heavy menstrual bleeding. Poster presentation at RCOG World Congress Singapore 2018. Yeoh M, Buttini M.
(Below is the text of a quality assurance audit performed in 2016 in this practice for follow up women 5 years post Mirena insertion at the time of endometrial ablation which might be of assistance to women suitable for the procedure considering this option as an alternative to hysterectomy)
Long term menstrual outcomes 5 years post Endometrial Ablation with concurrent insertion of Levonorgestrel Intrauterine Device in women seeking treatment for benign heavy menstrual bleeding
Authors: Dr Melissa Yeoh M.B.B.S.; Dr Melissa Buttini M.B., B.S FRANZCOG.
Background: Heavy menstrual bleeding (HMB) is a common reason for referral to gynaecological health services. Endometrial ablation (EA) Long term menstrual outcomes 5 years post Endometrial Ablation with concurrent insertion of Levonorgestrel Intrauterine Device in women seeking treatment for benign heavy menstrual bleeding and the Levonorgestrel intrauterine device (LNG-IUD) used alone are well accepted treatments, but can be associated with dissatisfaction such as irregular or recurrence of bleeding. The combination of EA and LNG-IUD aims to decrease menstrual bleeding further than either treatment alone and reduce the rate of more invasive treatments such as hysterectomy.
Aims: To assess menstrual outcomes and patient satisfaction 5 years post treatment in a cohort of patients treated with a combination of EA and LNG-IUD.
Method: A cohort of 148 consecutive patients who had undergone EA and concurrent insertion of LNG- IUD at least 5 years post treatment were identified. Seventy-six of these patients consented to and undertook a phone questionnaire to determine patient satisfaction and need for more definitive management. Long term qualitative was obtained by chart reviews and phone interviews in a total of 98 patients.
Results: Patient satisfaction was very high with an overall average rate of 9.6/10 at an average of 75 months. Complete amenorrhoea at greater than five years was 53.9%. 27.6% patients describing light PV spotting on average every 3.3 months, lasting and average 2.1 days. Eight hysterectomies were performed in 98 subjects subsequent to the original procedure.
Conclusions: EA with concurrent insertion of an LNG-IUD is an effective treatment for benign HMB with high rates of patient satisfaction and low rates of hysterectomy in up to 5 years of follow up in this cohort.
Heavy menstrual bleeding (HMB) is a benign and common reason for referral to gynaecological health services with up to 30% women seeking medical advice in their reproductive years(1). With newer, less invasive treatments such as endometrial ablation (EA) and the levonorgestrel-releasing intrauterine device (LNG-IUD), rates of hysterectomy have fallen by 45% in the past 30 years (2). There is well documented evidence for short and long term outcomes for EA and LNG-IUD alone (3,4,5). They are both valid alternatives to hysterectomy for the management of HMB, with lower complication rates, initial costs, and social inconvenience for the woman (6).
There is some information on short term outcomes for EA plus LNG-IUD (7,8,9). There is very limited information regarding outcomes greater than 24-48 months post procedure and information regarding outcomes of greater than four years (7,8,9). The use of both EA and the LNG-IUD aims to decrease bleeding symptoms further than either treatment alone, and possibly obviate the need for the more invasive and costly solution of hysterectomy altogether, with the expectation of more rapid return to normal work, social and sexual functioning. In addition to this, the LNG-IUD protects the endometrium against neoplastic change and can be used as a reliable long term contraceptive which is less invasive than tubal ligation for at least 5 years (10). Recent studies have shown is can be effective as a contraceptive for up to seven years (11).
The objective of this study is to ascertain short and long term outcomes and patient satisfaction for a combination of EA in addition to LNG-IUD in the treatment of HMB. Patient satisfaction was a self- assessment of their symptoms, with a rating out of ten.
Participants in the study were identified through a review of patients who had undergone EA in addition to insertion of an LNG-IUD from October 2009 to August 2011 at a private practice at Wesley Hospital, Brisbane, by searching the practice computer database for patients billed for the Medicare Benefits Schedule item number 35616, and undertaking chart reviews to identify those who had a LNG-IUD inserted at the time of the procedure. All patients who had undergone this procedure had signed a consent form and no longer wished to retain their fertility. They understood that pregnancy was contraindicated after EA, and subsequent removal of the LNG-IUD could be difficult due to intra- uterine adhesions. They understood that EA alone was not contraceptive. They were advised to return for a 6 week post-operative visit, and to return at 5 years to assess their menstrual function and contraceptive requirements, or sooner if they had concerns.
Once the potential candidates
for the study were identified,
attempts to contact them via
their last known telephone
numbers were made in order
to invite them to complete a
short invalidated confidential
regarding their symptoms
and satisfaction. (Figure 1)
Verbal consent was obtained
prior to participants
undertaking the phone
questionnaire and the
telephone survey was
conducted over a six month
period (17/5/16-2/11/16) having been advertised on the practice website. Ethics committee approval for the study was obtained through the UnitingCare Health HREC (Reference No: 2016.12.190). All participants had undergone a hysteroscopy and endometrial biopsy plus EA plus insertion of LNG-IUD under a general anaesthetic at The Wesley Hospital Day Surgery Centre, Brisbane.
Both thermal balloon ablation (Cavaterm) and Bipolar radiofrequency (NovaSure) ablation techniques were used. Endometrial histology was reviewed and no women had endometrial cancer identified at the time of the EA.
Primary outcomes included patient satisfaction at greater than five years after the procedure, and need and indication to proceed to more definitive management such as hysterectomy. Secondary outcomes included adverse short term outcomes, symptom, side effect profile and difficulty of removing or replacing the LNG-IUD (if required).
Figure 2 - flow diagram of short and long term
patient follow up
A total of 148 women who underwent
simultaneous EA in addition to insertion of a
LNG-IUD for the treatment of benign HMB
were identified in the inclusion time frame. Of
these women, 131 patients (88.5%) presented
for follow up at 6 weeks post operatively. A
total of 76 (51.3%) were able to be contacted
after 5 years and agreed to participate in the
telephone questionnaire. Information on
menstrual function from chart notes made at 5
year follow up on an additional 22 patients who
were not able to be contacted by telephone was
identified. Thus, data on 98 patients (66.2%) followed up for at least 5 years (by face to face appointment and/or phone questionnaire) was available. This is demonstrated in Figure 2.
The average age of treatment was 44.5 years (range 34-58), with the most common presenting complaint being heavy, regular bleeding (65.5% women), with a further 10.8% complaining of irregular, heavy bleeding, and 23.6% irregular bleeding. Of the women who complained of irregular bleeding, they had all previously trialled and been dissatisfied with medical management alone (LNG-IUD, combined oral contraceptive pill, Implanon). Associated dysmenorrhoea was noted in 29% participants. A total of 104 patients underwent thermal balloon ablation and 44 patients underwent bipolar radiofrequency for their ablation technique.
Menstrual outcomes at 5 years post treatment were available for a total of 98 patients and is demonstrated in Figure 3.
Fifty-nine (60.2%) patients described complete amenorrhoea at greater than five years, with twenty-three (23.4%) patients describing light PV spotting on average every 3.3 months.
This lasted on average 2.1 days (range 1-5 days), with fifteen women (65.2%) requiring a panty liner as protection, and six women (26%) not requiring any protection. Two women (9%) required a sanitary pad during this time
Eight hysterectomies were undertaken after the initial EA in addition to LNG-IUD, comprising five undergoing a TLH and three laparoscopic assisted vaginal hysterectomies (LAVH). Two patients underwent LAVH six months post initial procedure, both with the primary complaint of severe dysmenorrhoea. Of these, one patient was shown to have significant endometriosis, and both had evidence of adenomyosis on histology at hysterectomy. One patient underwent a TLH at 48 months for bleeding every six months and associated dysmenorrhoea. This patient was noted to have a history of chronic pelvic pain and histology of the uterus was unremarkable. Two patients underwent hysterectomies for new onset HMB, both at over 60 months, with the development during this time of a large, fibroid uterus. Two were performed for subsequent symptoms of pelvic organ prolapse (at 33 and 65 months respectively), and one for significant, constant pelvic pain and deep dyspareunia secondary to adhesions (at 54 months).
A total of twenty-eight IUDs were removed from those patients who had long term follow up, fourteen were replaced, with fourteen removed. A total of eight were removed or replaced under general anaesthetic, with two having hysteroscopically documented evidence of intra- uterine adhesions affecting the removal of the LNG-IUD. Twenty LNG-IUDs were removed in clinic with no difficulty. Of the women who had it replaced, 50% were for contraception and 28.5% were replaced to control bleeding. Two were replaced secondary to abnormal location. The indication for removal of 78% of LNG-IUD was because it had been 5 years since initial insertion. Of these women, six were over the age of 55 or documented menopause, and seven had documented forms of permanent contraception or tubal pathology.
No patient experienced postoperative complications. All ablations were performed as day only procedures, and there were no readmissions in the 6 weeks post ablation. One patient had her LNG-IUD removed by her general practitioner at one month as a result of a sensation of vaginal scratching and PV spotting and subsequently developed a painful haematometra requiring repeat hysteroscopy and reinsertion of the LNG-IUD seven months later.
Phone questionnaires were completed for 76 patients. Average time from treatment to phone questionnaire was 75 months (range 62-91 months). Overall satisfaction with the procedure was very high, with an average rating of 9.6/10 (range 0-10), and 72.7% of women rating the procedure at 10/10 for satisfaction. Satisfaction rates were similar between Cavaterm compared with Novasure (9.64 vs. 9.56/10).
Five patients (6.5%) of patients surveyed rated a satisfaction <8/10. Of these women, two went on to have a hysterectomy. One patient had a total laparoscopic hysterectomy (TLH) at 48 months for bleeding every 6 months with associated dysmenorrhoea on the background of chronic pelvic pain with normal histology. The second underwent a TLH for a large fibroid uterus at 64 months. Of the other three patients, one went on to have the LNG-IUD removed secondary to lower abdominal pain at three months, and two had the LNG-IUD at five years and had no further management for HMB.
Thirty-six (47.3%) women described menopausal symptoms at the time of the survey. Of these, three patients had some sort of hormone replacement therapy in the last 5 years. No patients had fallen pregnant since the procedure.
At the time of the telephone interview fifty-six (73.7%) women still had their original LNG-IUD in situ, whilst twelve (15.7%) had the LNG-IUD replaced at 5 years, mainly for contraception. Eight patients (10%) patients had the LNG-IUD removed and not replaced. Six patients had it removed at 5 years, one
following a new diagnosis of breast cancer, and one for ongoing lower abdominal pain at three months post procedure (pelvic ultrasound unremarkable). All women who had the LNG-IUD removed were either documented as menopausal or had another form of permanent contraception.
Both EA and LNG-IUD alone have been shown to be effective in the treatment of HMB (3,12,13) and are an alternative to the definitive, but more costly alternative of hysterectomy with its potential surgical risks in women who no longer desire to retain their fertility. Complete amenorrhoea is a highly desired outcome of treatment for HMB, and recurrent irregular and inconvenient vaginal bleeding, even if light, is a source of dissatisfaction deriving from less invasive treatments which can lead to requests for hysterectomy. Improving the woman’s bleeding pattern by combining less invasive treatments might prevent requests for subsequent hysterectomy, whilst awaiting the onset of natural menopause. Destroying as much endometrium as possible by ablation might help prevent ongoing annoying irregular bleeding in users of the LNG-IUD. In addition insertion of an LNG-IUD at the time of ablation might help prevent post ablation haematometra, and protect the endometrium against neoplastic transformation in the perimenopause, whilst providing highly effective contraception.
The Cochrane Database of Systematic Reviews examined the topic of EA alone (3) and noted that 88% of women had an improvement in menstrual bleeding within one year following treatment for second generation EA techniques, and 35% reported amenorrhoea at one year. 26% required additional treatment (mostly hysterectomy) within five years of initial treatment (3). Patient factors for requiring additional treatment include younger age, parity greater than three, previous caesarean section and pre- operative dysmenorrhoea (14).
The rates of amenorrhoea with LNG-IUD for the treatment of abnormal uterine bleeding after one year has been reported at 35% at two years (12). Irregular bleeding was the most common reason for removal. Additional treatment for the treatment of HMB to be approximately 25% (12,13).
When EA was compared to LNG-IUD, subjective control of bleeding was more likely to have occurred in the LNG-IUD group (12). There was no difference in patient satisfaction at two years (12). There appeared to be higher rates of hysterectomy (24% vs. 3.7%) and lower rates of patient satisfaction in the EA group at 5 years compared to the LNG-IUD group (5 ). When comparing these results to our study, our rates of hysterectomy were significantly lower at 8.1% (total eight patients) when compared to endometrial ablation, however this trial showed much lower rates of hysterectomy or treatment failure with LNG-IUD compared to other trials usually approximately 25%(12,13). This is possibly due to sample size of the study, with 30 and 28 patients in each group. The age of our cohort was slightly older (average 44.5 years compared to 42 and 43). There was limited information regarding the reasons for hysterectomy in each group. EA in addition to LNG-IUD can also be used as an alternative for women with symptoms suggestive of adenomyosis who may have a less than optimal outcome with EA or LNG-IUD alone.
EA plus LNG-IUD was associated with a significant decrease in the rates of patient perceived treatment failure compared to EA alone, including rates of subsequent treatment. The need for further treatment in the EA only group was higher than the EA plus LNG-IUD group (29% compared to 8.7% at four years) ( 8,14). Rates of amenorrhoea were significantly higher in the EA plus LNG-IUD group compared to EA alone at one year (14). When comparing EA plus LNG-IUD versus LNG-IUD alone, there appeared to be a significant reduction in menstrual flow in both groups follow up for 12 months (9). Short and medium outcomes for the use of EA plus LNG-IUD have been compared to the treatments with an average follow-up of 25 months. Our study adds to these findings, with high satisfaction rates at greater than 60 months and low rates of subsequent procedure, including hysterectomy.
Removal of the LNG-IUD post EA has been one concern raised when employing both treatments simultaneously. Documented rates of intra-uterine scar tissue post procedure and difficulty of removing LNG-IUD was low (10.5%) in this cohort, but did require a subsequent hysteroscopy on eight occasions. Patients should be advised of this possibility.
Finally, the LNG-IUD is licenced (in Australia) for contraception for 5 years, so ongoing contraceptive requirements of women need to be assessed and the IUD replaced, alternative contraception arranged, or menopause documented by serial estimation of Follicle Stimulating Hormone at 5 years post insertion. It should be noted however that contraceptive efficacy for up to 7 years has more recently been established (11). For this reason, combining EA with the LNG-IUD as an alternative to hysterectomy for women 45 years of age or older who are anticipating the natural onset of menopause in that time frame, and wish to avoid major surgery.
Our response rate to the phone survey was 51.3%. Of these women, eleven did not have a current phone number on record, two women had moved overseas, and three declined to participate in the phone survey. The remainder did not answer on multiple attempts and did not respond to a voice message. A total of fifty women did not have long term follow-up with the treating gynaecologist despite instructions to do so. Clinicians should be mindful of loss to follow up with long term treatments and
emphasise as part of the initial consent process the importance of returning to discuss ongoing contraceptive requirements and potential implications associated with a pregnancy after an EA.
EA in addition to LNG-IUD for the treatment of HMB has been shown to be an effective treatment for benign HMB in this cohort at 5 years follow up, and could be an alternative to hysterectomy for women no longer desirous of retaining their fertility. Long term satisfaction at greater than five years in this cohort of women was high (average rating 9.6 out of 10) and rates of hysterectomy in the follow up period were low (8%). Further long term studies of this combination of treatment could help to provide information useful to patients and clinicians.
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" Although hysterectomy is a definitive treatment for heavy menstrual bleeding, it can cause serious complications and most women may be well advised to try a less radical treatment as first-line therapy. Both LNG-IUS (Mirena) and conservative surgery (Endometrial Ablation) appear to be safe, acceptable and effective."
(Cochrane Database of Systematic Reviews, January 2016)
Dr Melissa Buttini m.b.b.s franzcog