Health-Related Quality of Life Among Iranian Women With Uterine Fibroids: A Cross Sectional Study.

Uterine fibroids (UFs) are the most common benign gynecological tumors that originate from the smooth muscles of the uterus ( 1 ). The prevalence of UFs in reproductive-aged women ranges from between 5.4 to 77.0%, depending on the diagnostic methods and the study population ( 2 ). However, owing to many asymptomatic cases, the majority of UFs remain undiagnosed, leading to the underestimation of their prevalence ( 2 ). Several risk factors such as age, race, obesity, parity, hypertension, vitamin D deficiency, and late-life diets, contribute to the development of UFs ( 3 ). Untreated UFs can lead to various debilitating complications, including acute or chronic pelvic pain, anemia, hydronephrosis, premature delivery, and fetal intrauterine growth retardation ( 4 ). Beyond the impact on individual health, the high prevalence of UFs has substantial implications for global healthcare expenditure. The annual direct and indirect costs associated with UFs are estimated at $34.4 billion in the United States ( 5 ). Moreover, symptomatic UFs cause substantial morbidity and profoundly impact the quality of life of reproductive-aged women, thereby presenting a growing public health concern worldwide ( 5 ). Recent surveys on women in the United States, Canada, France, and Spain have highlighted the substantial impact of fibroid-related symptoms on health-related quality of life (HRQOL). These symptoms are associated with prolonged menstruation, increased healthcare visits and analgesic consumption, greater direct and indirect costs, and increased workplace absenteeism ( 6 ). Furthermore, the symptoms of UFs have a negative impact on both affected women and the general population due to economic loss and decreased productivity ( 7 ). Since the Persian version of UFS-QOL questionnaire is validated recently ( 8 ), this study aimed to investigate the HRQOL in Iranian women with UFs considering the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) questionnaire.

Baseline characteristics of the patients: Of 234 patients initially included in the study, 14 were excluded due to the following reasons: adenomyosis ( 3 ), gynecologic cancers ( 10 ), and pregnancy ( 1 ). Finally, 220 samples with a mean age of 43.10±5.01 years (range: 18 to 45 years) entered the analysis. The majority of them had a normal body mass index (BMI) (43.1%), while others were overweight (36.7%) or obese (20.2%). On ultrasound assessment, 56.4% had one UFs, 21.3% had two UFs, and the remaining (22.3%) had three or more UFs. According to the International Federation of Gynaecology and Obstetrics (FIGO) classification system, the most common location of the UFs was 4 or intramural (49.1%), followed by 6 (19.5%), 5 (15.9%), 7 (5.3%), 2 (3.5%), 0 (2.7%), 1 (2.7%), and 8 (1.3%). Patients had total UFS-QOL score of 64.11±20.35 with the following subscales’ scores: symptom severity: (19.00±6.39), concern: (60.79±26.47), activities: (71.76±23.02), energy/mood: (54.39±25.14), control: (66.52±22.82), self-consciousness: (77.63±26.39), and sexual function: (59.40±31.18) ( Table 1 ). Total UFS-QOL Score and its subscales UFS-QOL; Uterine Fibroid Symptom and Health-Related Quality of Life, SD; Standard deviation Table 2 illustrates the association between variables and the total HRQOL score. According to the findings, these variables were not significantly associated with the HRQOL. Patients with multiparity history had significantly lower HRQOL scores than those with monoparity (P=0.213) and nulliparity (P=0.001). Obese patients had significantly lower HRQOL scores than those with normal BMI (P=0.002) and overweights (P<0.001) ( Figure 1 ). Regarding menstrual duration, women with increased menstrual duration had lower HRQOL scores than those with normal (P<0.001) or decreased (P=0.013) menstrual duration. Patients with regular menstrual cycles had higher HRQOL scores than those with irregular menstrual cycles (P<0.001). Furthermore, women with hypermenorrhea had lower HRQOL scores than those with normal menstrual volume (P<0.001) or hypomenorrhea (P=0.009) ( Figure 2 ). Association between Demographic factors (Parity and BMI) and UFS-QOL Association between Menstrual features and HRQOL Association between variables and health-related quality of life (HRQOL) score HRQOL; Health-related quality of life, UFs; uterine fibroids, FIGO; International Federation of Gynaecology and Obstetrics ANOVA, Independent Sample T-Test

The study results indicated that patients with UFs had acceptable UFS-QOL scores. Health-related quality of life in these patients can be affected by certain factors, such as features of the menstrual cycle, multiparity, and obesity.

In the current study, we evaluated the association between total HRQOL and socio-demographic characteristics, familial history of UF, size of the largest UF, number of UFs, FIGO of the largest UF, and menstrual cycle features of patients. Our study findings revealed that menstrual features such as menstrual regularity, volume, and duration were associated with HRQOL. This study showed that the most common anatomical location of the UFs was intramural, followed by subserosal and submucosal, which is consistent with previous studies reporting the anatomical distribution of UFs ( 12 , 13 ). In our study, most patients were in the fourth decade of their lives. According to a study, the risk of UF grows with age, peaks at 35 to 44 years, and then gradually decreases. In this study, it was found that age was not associated with HRQOL score, which is similar to the findings of a publication from Japan ( 14 ). However, another study found that older patients had significantly lower symptom severity and higher HRQOL scores ( 15 ). Older patients may unaccuartely respond the questionnaire. Additionaly, other medical conditions, which effect on quality of life, can play the role of confounding variables. This discrepancy among the results regarding the association between age and HRQOL score may be attributed to varying age limits used across studies. While we found that obese women had significantly lower HRQOL scores, a previous study reported that the only UFS-QOL subscale that was affected negatively by BMI was self-consciousness ( 15 ). Inconsistent with our finding, a study by Soliman et al. reported that almost all subscales of HRQOL were negatively associated with educational level ( 15 ). This difference could be resulted from variations in sample sizes of different studies. We also excluded illiterate patients, which could significantly influence the evaluation of the relationship between HRQOL and educational level. The results of the study by Zimmermann et al. showed that bleeding symptoms of UFs had a significant negative impact on women’s quality of life ( 16 ). We found that patients with prolonged menstrual duration, hypermenorrhea, and irregular menstruation had significantly lower HRQOL scores. These findings are consistent with several previous studies that have demonstrated the negative impact of bleeding symptoms on HRQOL ( 14 , 15 ). A study by Brito et al. showed that patients with UFs who suffered from bleeding symptoms often felt fear and anxiety due to the unpredictability of these symptoms ( 17 ). Most of them reported that they had to carry extra pads with themselves most of the time. They were concerned and embarrassed about the soiling of underclothing ( 15 , 17 ). Patients stated that irregular and prolonged menses made them think of having no control over their lives. They also reported using pads during the night, which caused sleep impairments ( 17 ). Furthermore, heavy and irregular menstruation can lead to abstinence from school and work, reduced social activities, and impaired sexual functions ( 18 ). Other consequences of these symptoms include adverse effects of hormonal treatments, anemia, and as a result, fatigue and loss of concentration ( 17 ). In the present study, we found no significant relationship between the size or number of UFs and HRQOL scores. Inconsistent with our findings, another study showed that the size of leiomyoma was significantly correlated with the severity of genitourinary symptoms and impairment of quality of life ( 19 ). Unlike the mentioned study, we excluded patients with fibroids larger than 10 cm, which could contribute to the conflicting findings observed. However, other studies reported that size of the uterine fibroid did not affect HRQOL ( 20 , 21 ). This study was the first study that assessed the health related quality of life in Iranian women with UFs based on UFS-QOL questionnaire. Face to face interview can establish connection between the interviewer and patients and can provide better understanding, thus using this method instead of online questionnaires, which are commonly used in studies, is considered a substantial strength of this study. Our study had some limitations. The cross-sectional design of the study and lack of a control group restricted the capability of exploring causality, and only associations between variables could be evaluated. Our research project was carried out in only one medical center, and the sample size was small, which limited the generalizability of the findings.

Study design and participants: This cross-sectional study was performed at Imam Hossein Hospital, Tehran, Iran, between November 2023 and February 2024. The inclusion criteria were: women with UFs diagnosed with ultrasound by an expert radiologist, largest diameter of UFs between 2 and 10 cm, age between 18 and 45 years, and literacy for reading and writing. Patients with the following features were also excluded: history of surgery due to gynecological diseases, underlying chronic diseases (diabetes, hypertension, rheumatological diseases, psychological disorders, and cancer), presence of other pathologies visualized by ultrasound (e.g., adenomyosis or gynecological malignancies), and pregnancy or breastfeeding. Data collection: In this study, the data were collected using the census method. After explaining the purpose of the study, the eligible patients signed an informed consent form for study participation. The study participants were interviewed by a research team member regarding their demographics and clinical characteristics. Ultrasound findings of the patients were obtained by reviewing their medical records. Finally, participants completed the UFSQOL questionnaire. Study instrument: Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) is a 37-item questionnaire assessing symptom severity and HRQOL in women with UFs over the previous three months. Each item is scored on a Likert scale ranging from 1 (none of the time/not at all) to 5 (a very great deal/all the time). In this questionnaire, higher scores indicate better quality of life. This questionnaire consists of seven subscales, one of them is symptom severity and the others are health-related quality of life as follows: concern, activities, energy/mood, control, self-consciousness, and sexual function. The original English version of the UFS-QOL questionnaire was developed by Spies et al., which had acceptable validity and reliability ( 9 ). Additionally, a study by Najafiarab et al. reported the reliability and validity of the Persian version of the UFS-QOL questionnaire with a Cronbach’s alpha coefficient of 0.956 ( 8 ). Symptom severity score range between 0–100, and score ≥ 40 indicates moderate to severe symptoms, and HRQOL range from 0–100; a higher score indicates better quality of life ( 10 ). Statistical analysis: Data were analyzed using the IBM Statistical Package for Social Sciences (SPSS) ® software version 23.0. Variables were described as frequency, percentage, mean, and standard deviation. Variables were compared between groups using the independent-samples t -test and ANOVA followed by post-hoc tests (Tukey). In this study, a P-value less than 0.05 was considered statistically significant. Ethical considerations: The Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran, approved the study protocol (IR.SBMU.RETECH.REC.1402.384). All the study steps were performed followed by the Declaration of Helsinki 2000.