Recommendations for research

The guideline committee has made the following recommendations for research.

1 Hysteroscopy compared with ultrasound or empiric pharmacological treatment in the diagnosis and management of heavy menstrual bleeding (HMB)

Is initial testing using hysteroscopy more effective than testing with pelvic ultrasound or empiric pharmacological treatment in the diagnosis and management of HMB?

Why this is important

There is no consensus about the best test-and-treat strategy for women with HMB, and empiric pharmacological treatment is often initiated as a first treatment without investigation. Parameters of diagnostic accuracy give useful information about a test's ability to detect a condition (or the absence of a condition). But accurate diagnosis does not automatically result in a better overall outcome for the woman, because this also depends on treatment decisions after the diagnosis is made. However, it is thought that optimal treatment depends on accurate diagnosis of the underlying pathology causing HMB.

In the absence of clinical trials, decision analytical economic models evaluating all possible outpatient testing algorithms have indicated that using ultrasound or hysteroscopy for initial diagnostic testing for women with HMB are the most effective diagnostic strategies. Pelvic ultrasound has been most commonly used because it has been more widely available and is considered less intrusive than hysteroscopy. However, advances in technology mean that the hysteroscopy is well tolerated in the outpatient setting, and it can potentially be performed outside the traditional hospital environment in a community setting. Moreover, in contrast with ultrasound, hysteroscopy allows concomitant treatment of intrauterine pathologies such as submucosal fibroids and endometrial polyps. It also facilitates the fitting of levonorgestrel-releasing intrauterine systems (LNG-IUS).

A test-and-treat randomised controlled trial with cost-effectiveness analysis could help to answer the crucial question of whether hysteroscopy improves outcomes for women and results in more effective use of NHS resources.

2 Effectiveness of the progestogen-only pill, injectable progestogens, or progestogen implants in alleviating HMB

How effective are the progestogen-only pill, injectable progestogens or progestogen implants in alleviating HMB?

Why this is important

Many women use LNG-IUS as the first-line pharmacological treatment for HMB, but it is not acceptable to all women. Combined oral contraceptives have also been shown to be effective for treating HMB, but their use is contraindicated in some women. Other progestogens used for contraception have far fewer contraindications than combined contraceptives, but their effectiveness as a treatment for HMB has not been studied.

A randomised controlled trial or cohort prospective observational study could compare the effectiveness of progestogens with other pharmacological treatments for HMB.

3 Long-term outcomes of pharmacological and uterine-sparing surgical treatments for HMB associated with adenomyosis

What are the long-term clinical outcomes of pharmacological and uterine-sparing surgical treatments in women with HMB associated with adenomyosis?

Why this is important

Adenomyosis is common, and the symptoms cause significant morbidity, including restriction of daily activities. A wide range of incidences have been suggested, but most studies report a prevalence of between 20 and 35%. Despite this, there is little evidence about the impact of adenomyosis on symptoms of HMB or the best treatment for this condition. Optimising treatment can lead to better patient satisfaction and the avoidance of unnecessary investigations and treatments. In order to do this, a better understanding of the impact of adenomyosis in causing HMB, pain and subfertility is needed.

A prospective clinical registry would allow long-term clinical outcomes such as patient satisfaction and re-intervention for refractory symptoms, to be recorded after pharmacological and uterine-sparing surgical treatments for women with adenomyosis.

4 Hysteroscopic removal of submucosal fibroids compared with other uterine-sparing treatments for HMB

Is hysteroscopic removal of submucosal fibroids more effective and cost-effective than other uterine-sparing treatments for the management of HMB?

Why this is important

HMB is thought to be caused by submucosal fibroids in around 15% of women. Such fibroids are amenable to minimally invasive surgical removal ('hysteroscopic myomectomy'), avoiding the need for surgical incision. Non-comparative data have reported improvement in HMB symptoms and the avoidance of further pharmacological or surgical treatment in 70 to 80% of women treated with hysteroscopic myomectomy.

Specific hysteroscopic surgical skills are necessary to optimise surgical success and minimise complications. However, recent advances in endoscopic technologies have made hysteroscopic myomectomy potentially safer and more feasible.

A randomised controlled trial comparing this technique with long-term pharmacological therapy or more invasive surgical intervention would provide information on long-term outcomes.

5 Second-generation endometrial ablation for HMB associated with myometrial pathology

Are outcomes after second-generation endometrial ablation for women with HMB associated with myometrial pathology (adenomyosis and/or uterine fibroids) equivalent to those for women without myometrial pathology?

Why this is important

With the wider availability of high-resolution transvaginal pelvic ultrasound, adenomyosis and fibroids have been recognised as 2 of the most common uterine pathologies in women presenting with HMB. Pharmacological treatments appear to be less effective in the presence of these conditions, making referral to specialist care for surgery more likely.

Second-generation endometrial ablation is a minimally invasive, uterine-sparing surgical procedure, but its effectiveness in women with adenomyosis or uterine fibroids is unclear. Thus women with these conditions may be denied second-generation endometrial ablation and undergo unnecessary invasive surgery such as hysterectomy. On the other hand, women may be subjected to ineffective second-generation endometrial ablation that delays more effective treatment such as hysterectomy. It is therefore important to evaluate the effectiveness of second-generation endometrial ablation in women with these conditions, and a cohort controlled study is suggested as the best approach for doing this.