Hysteroscopic treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study

Clark, T. Justin; Mahajan, Deepa; Sunder, Ponnamal; Gupta, Janesh

doi:10.1016/s0301-2115(01)00485-7

Cited by 65 publications

(26 citation statements)

References 13 publications

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“…l VAS to measure monthly bleeding quantity and duration It is now well established that objective measures of blood loss are not particularly relevant to women's subjective perception of bleeding symptoms. 126 For those patients with HMB (group A in Figure 6), our pilot work 97,128 has demonstrated that improvements in VAS scores correlate very well with improvements in categorical and condition-specific quality-of-life measures. The reliability of VAS has been established in the assessment of chronic gynaecological conditions, such as pain, 129 and change in individual VAS scores were considered to have sufficient psychometric strengths to be used in the research of AUB involving large group comparisons.…”

Section: Secondary Clinical Outcome Measuresmentioning

confidence: 94%

“…It is for this reason that many recommend polypectomy under direct visualisation using hysteroscopic methods. 32,81,84,107,128 It is possible that the likelihood of unrecognised injury is greater where conventional, more traumatic blind techniques using larger mechanical equipment are adopted in an unconscious inpatient. Such approaches were observed much less frequently in the outpatient treatment group of the OPT Trial.…”

Section: Evidence Of Effectivenessmentioning

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: Secondary Clinical Outcome Measuresmentioning

confidence: 94%

Section: Evidence Of Effectivenessmentioning

confidence: 99%

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

Clark

Middleton

Cooper

et al. 2015

Health Technol Assess

View full text Add to dashboard Cite

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“…7 This is consistent with Sculpher et al who reported little change in health-related quality of life between 4 months and 1 year after hysterectomy. 30 Utility following treatment with MRgFUS is 0.783 (based on UF002). Similar utility is assumed following UAE.…”

Section: Methodsmentioning

confidence: 99%

Cost-Effectiveness of Magnetic Resonance-Guided Focused Ultrasound Surgery for Treatment of Uterine Fibroids

Zowall

Cairns

Brewer

et al. 2008

Obstetrical &Amp; Gynecological Survey

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Objective To estimate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids, which starts with Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) as compared with current practice comprising uterine artery embolisation, myomectomy and hysterectomy.Design Cost-utility analysis based on a Markov model.Setting National Health Service (NHS) Trusts in England and Wales.Population Women for whom surgical treatment for uterine fibroids is being considered.Methods The parameters of the Markov model of the treatment of uterine fibroids are drawn from a series of clinical studies of MRgFUS, and from the clinical effectiveness literature. Healthrelated quality of life is measured using the 6D. Costs are estimated from the perspective of the NHS. The impact of uncertainty is examined using deterministic and probabilistic sensitivity analysis. Main outcome measures Incremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained.Results The base-case results imply a cost saving and a small QALY gain per woman as a result of an MRgFUS treatment strategy. The cost per QALY gained is sensitive to cost of MRgFUS relative to other treatments, the age of the woman and the nonperfused volume relative to the total fibroids volume.Conclusions A treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective.Keywords Cost-utility analysis, focused ultrasound surgery, uterine fibroids.Please cite this paper as: Zowall H, Cairns J, Brewer C, Lamping D, Gedroyc W, Regan L. Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids. BJOG 2008;115:653-662.

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“…18 EA is recommended as a second-line treatment where fertility is not desired and medical treatment has failed in DUB, but can also be used in the presence of uterine fibroids where there is a relatively normal-sized and -shaped uterine cavity. Hysteroscopic resection of focal intracavity lesions, including polyps 40,41 and SMFs, [42][43][44][45][46] has been shown to improve HMB symptoms found in association with these pathologies. Hysteroscopic removal is standard practice in the UK 47 and in the case of polyps can be achieved in the majority of cases in the outpatient setting.…”

Section: Surgical Treatmentmentioning

confidence: 99%

“…Nine studies reported satisfaction after transcervical myomectomy but seven were rejected because they had fewer than 40 patients 121,122 or reported satisfaction data from more than 3 years after treatment. 44,[123][124][125][126] The two remaining studies 42,46 were both prospectively conducted and had populations of over 100 women, with more than 90% being pre-menopausal.…”

Section: Polyp/submucosal Fibroids Removalmentioning

confidence: 99%

Cost-effectiveness of diagnostic strategies for the management of abnormal uterine bleeding (heavy menstrual bleeding and post-menopausal bleeding): a decision analysis

Cooper

Barton

Breijer

et al. 2014

Health Technology Assessment

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Hysteroscopic treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study

Cited by 65 publications

References 13 publications

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

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

Cost-Effectiveness of Magnetic Resonance-Guided Focused Ultrasound Surgery for Treatment of Uterine Fibroids

Cost-effectiveness of diagnostic strategies for the management of abnormal uterine bleeding (heavy menstrual bleeding and post-menopausal bleeding): a decision analysis

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