Follow-up of Women After a First Episode of Postmenopausal Bleeding and Endometrial Thickness Greater Than 4 Millimeters

Timmermans, Anne; Doorn, Lena C. van; Opmeer, Brent C.; Kroeks, M. V. A. M.; Duk, M. Jitze; Bouwmeester, Annette M.; Kruitwagen, Roy F.P.M.; Dijkhuizen, F. P. H. L. J.; Mol, Ben Willem J.

doi:10.1097/01.aog.0000296654.43944.e6

Cited by 18 publications

(16 citation statements)

References 14 publications

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“…23,97 The majority of studies defined the primary outcome as an improvement in symptoms of AUB as perceived by the patient. All of the studies 23,75,91,97,101,[105][106][107][108][109][110][111][112][113][114][115] (plus TJ Clark, unpublished) reported an improvement in symptoms from 60% to 100%. The study looking exclusively at postmenopausal patients presented a survival analysis curve.…”

Section: Discussionmentioning

confidence: 99%

“…The 17 studies 23,75,91,97,101,[105][106][107][108][109][110][111][112][113][114] (including TJ Clark, Birmingham Women's Hospital, 2013, unpublished) that met our inclusion criteria enrolled a total of 1829 patients between 1989 and 2009. The population size ranged from 8 to 311, with only five studies having a population size of > 100.…”

Section: Included Studiesmentioning

confidence: 99%

“…105 The remaining 13 articles were uncontrolled observational studies. Only six of the studies were prospective, although the majority of the studies 23,75,97,113,114 (plus TJ Clark, unpublished) collected the data consecutively (Figures 2 and 3; Table 2). …”

Section: Included Studiesmentioning

confidence: 99%

“…One study looked exclusively at women suffering from PMB, 113 seven studies looked at only women who were premenopausal 23,75,106,107,109,111,112 and the remaining nine studies 91,97,101,105,108,110,114,115 (plus TJ Clark, unpublished) examined mixed populations of women with AUB. Per cent (%)…”

Section: Participant Characteristicsmentioning

confidence: 99%

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A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding

Clark

Middleton

Cooper

et al. 2015

Health Technol Assess

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BackgroundUterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited.ObjectivesTo test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined.DesignA multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study.SettingOutpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals.ParticipantsWomen with AUB – defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding – and hysteroscopically diagnosed uterine polyps.InterventionsWe randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia.Main outcome measuresThe primary outcome was successful treatment at 6 months, determined by the woman’s assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained.ResultsAt 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively.ConclusionsWhen treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower.Trial registrationCurrent Controlled Trials ISRCTN 65868569.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 61. See the NIHR Journals Library website for further project information.

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Section: Discussionmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

Section: Participant Characteristicsmentioning

confidence: 99%

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A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding

Clark

Middleton

Cooper

et al. 2015

Health Technol Assess

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“…A multicentre study by Ferrazzi et al (2009) found only one case of a grade-1 endometrial cancer in 1152 asymptomatic women with endometrial polyps. Another cohort study found no difference in the recurrence rate of PMB between those women who had a polypectomy, those who had a normal hysteroscopy, and those patients who had just office endometrial sampling (Timmermans et al, 2008). Ultimately, the decision as to whether a polyp is removed or not needs to be made in secondary care.…”

Section: Endometrial and Cervical Polypsmentioning

confidence: 99%

Postmenopausal bleeding

Pugh

Humphries

2013

InnovAiT: Education and inspiration for general practice

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Postmenopausal bleeding (PMB) is one of the most common reasons for referral to gynaecology services. This is due to the concern of possible underlying malignancy, as approximately 10% of women with PMB will have endometrial cancer. With growing use of hormone replacement therapy there is increased uncertainty as to what constitutes unscheduled bleeding and careful history and examination is required. Although benign conditions represent the most frequent cause of PMB, all women will require urgent referral and investigation in secondary care.

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