Abnormal uterine bleeding associated with a benign polyp Urological and Genital Diseases Abnormal uterine bleeding associated with a benign polyp
Conditions
Interventions
Current interventions as of 01/09/2011:
Outpatient polypectomy will be performed immediately following diagnosis at outpatient hysteroscopy in most instances, although some participants may have their
Sponsors
University of Birmingham and Birmingham Women's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Abnormal uterine bleeding requiring diagnostic microhysteroscopy 2. Finding of a benign polyp (glandulocystic or pedunculated/grade 0 fibroid) on diagnostic microhysteroscopy 3. No hysteroscopic features suspicious of malignancy 4. Need for polypectomy
Exclusion criteria
Exclusion criteria: 1. Hysteroscopic features suggesting malignant lesion 2. Additional pathology necessitating hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/09/2011: The patient's own assessment of bleeding symptoms at 6 months, using a dichotomous outcome measure, will be used to establish if the treatment has been successful. The question used for this measure will be dependent on whether the patient is pre or post-menopausal, predominant complaint at randomisation and type of HRT they may be using. Further details can be seen in Figure 2 (protocol v2.2 page 9). In all cases a 'yes' response will be defined as a success. Previous primary outcome measure: Abnormal uterine bleeding (post-menopausal, unscheduled bleeding on Hormone Replacement Therapy [HRT]/tamoxifen or intermenstrual bleeding) at 6 months measured by visual analogue scale (0 = no bleeding; 10 = continuous bleeding) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/09/2011: The following secondary outcomes will be assessed by a booklet sent to the women at home containing questionnaires/questions at baseline, 6, 12 and 24 months post-randomisation: 1. Shaw Menorrhagia assessment scale A multi-attribute utility, designed to measure the impact of heavy menstrual bleeding (menorrhagia) upon HRQL 2. Likert scale. All patients will be asked how their bleeding has responded to treatment using a Likert scale with four response options 3. Health related quality of life measured by EuroQol EQ-5D Instrument 4. Visual analogue scale (VAS) It is now well established that objective measures of blood loss are not particularly relevant to women's subjective perception of bleeding symptoms Previous secondary outcomes measures: The following secondary outcomes will be assessed by a booklet sent to the women at home containing questionnaires/questions at baseline, 3, 6, 12 and 24 months post-randomisation: 1. Abnormal uterine bleeding (as above) measured at 3, 12 and 24 months 2. Health related quality of life measured by the multi-attribute utility menorrhagia assessment scale (if type of abnormal uterine bleeding is menorrhagia) 3. Satisfaction with treatment outcome 4. Sexual function measured by Sexual Activity Questionnaire 5. Health related quality of life measured by EuroQol EQ-5D Instrument 6. Patient anxiety and preference at baseline 7. Patient acceptability of uterine polypectomy (OPT vs inpatient treatment) 8. Data on economic endpoints (i.e. health resource utilisation e.g. general practice and hospital visits, days off work etc.) at 3, 6 and 12 months 9. Other measures will include information on technical feasibility (baseline) and complications of surgery (baseline, 3, 6 and 12 months). In addition we will perform a follow-up diagnostic outpatient microhysteroscopy at six months to assess completeness of treatment. The uterine cavity will be examined for persistence or recurr | — |
Countries
United Kingdom
Outcome results
None listed