This was a prospective observational study over a 1 year period undertaken at the Aga Khan University Hospital Nairobi (AKUH-N) including patients with symptomatic uterine fibroids who had opted for uterine fibroid embolisation (UFE). The patients had presented to the gynaecology clinic with symptomatic fibroid disease and had been offered treatment options including medical approaches, myomectomy (open and laparoscopic), hysterectomy (open and laparoscopic), hysteroscopic resection and UFE after appropriate counselling.
The primary outcome was change in symptom severity using the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL) 1 year after the procedure. This questionnaire is available in the Additional file 1. Secondary outcomes examined were changes in HRQOL, and potential associations of changes in symptom severity and health-related quality of life with age, parity, uterine volume and fibroid number prior to UFE. Additional interventions after UFE were recorded with readmission considered as a complication of the procedure. Subsequent myomectomy and hysterectomy were classified as major surgical procedures while hysteroscopy and curettage were classified as minor surgical procedures.
Following approval by the Aga Khan University Research Ethics Committee, participants were enrolled into the study by consecutive selection. Potential participants of Black African descent scheduled for UFE were approached after MR imaging of the pelvis. Exclusions were made on the basis of clinical assessment, relevant clinical investigations and MRI of the uterus and criteria included difficulty in completing English language questionnaires, pathology other than fibroids on MRI, previous UFE, pregnancy, active infection and suspicion of cancer. Patients with a desire to maintain child bearing potential were only recruited after appropriate counseling owing to the uncertain effects of the procedure on ovarian function . Written informed consent was obtained and a validated English language questionnaire instrument, the UFS-QOL  was then completed by participants after a brief clinical history. The uterine fibroid symptom and quality of life questionnaire (UFS-QOL) is a disease-specific questionnaire. It assesses symptom severity and HRQOL in patients with uterine fibroids and consists of an 8-item symptom severity scale and 29 HRQOL items covering six domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from “not at all” to “a very great deal” for symptom severity items and “none of the time” to “all of the time” for the HRQOL items. Symptom severity and HRQOL subscale scores are summed and transformed into a percentage scale. The symptom severity scale and HRQOL subscale scores are inversely related, with higher symptom severity scores indicating greater symptoms and higher HRQOL subscale scores indicating better HRQOL.
All questionnaires bore a unique participant identification number and names of study participants did not appear on them for purposes of confidentiality. The same questionnaire (UFS-QOL) was administered again after 1 year through email and telephone interviews. Participants were sent reminders after 11 months of the procedure via text messages, telephone calls and email. Follow up for clinical assessment after UFE was undertaken by each patient’s responsible clinician separate from contacts for study data collection.
The uterine volume, volume of the dominant fibroid and number of fibroids prior to UFE were ascertained independently by two radiologists using the pre-UFE pelvic MRI examination. Volumes were determined by measuring the maximum extent of the uterus and dominant leiomyoma in three planes and multiplying the product by 0.5233 (ellipsoid volume formula) . An experienced interventional radiologist (NH) carried out embolisation under conscious sedation using spongostan gelfoam (ETHICON) in the hospital’s cardiac catheterization suite via a transfemoral approach. Pain relief was undertaken using a UFE pain relief protocol previously described  and participants were discharged from hospital within 24 h of the procedure and provided with oral pain medication. Participants did not undergo routine follow up MR imaging as previous work in our unit indicated that the extent of shrinkage did not correlate directly with symptomatic improvement . We based our sample size calculation on the outcomes from the FIBROID Registry  in which the mean change in symptom severity score was −38.94 (SD ± 24.79), SE 0.52. Given a power of 90% with a 5% significance level, and a null hypothesis value of 70% of the mean change in symptom severity, the sample size was 57 having factored an estimated loss to follow-up of 20%. Data were analysed using STATA version 12 Special Edition and summary statistics tabulated. Statistical significance of differences was tested using t tests, Wilcoxon rank sum tests and Fisher’s exact tests as appropriate taking 5% probability as significant. Age, parity, uterine volume, volume of the dominant fibroid and number of fibroids prior to UFE were categorized into groups for analysis using clinically relevant limits. Potential associations between age, parity, uterine volume, fibroid number prior to UFE and the outcome variables of symptom score change and HRQOL score change were examined using Pearson’s correlation coefficient. Scatter plots with superimposed regression lines were used to illustrate the underlying relationships. Study participants whose data were missing were excluded from the final analysis. However, baseline characteristics for those lost to follow-up were compared to those who completed the study.