Abstract
Background and Objectives:
Uterine fibroids are common in women and can lead to symptoms of abnormal uterine bleeding, pelvic pain and bulk symptoms. Treatment can be medical or surgical. This study aims to describe characteristics and outcomes of women undergoing combined laparoscopic radiofrequency ablation (lap-RFA) and laparoscopic myomectomy (lap-MYO) to treat symptomatic uterine fibroids.
Methods:
This is a multicenter prospective cohort study including both academic centers and private practices. Women in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study who were scheduled to undergo surgical management of fibroids underwent a combined lap-RFA and lap-MYO. We assessed quality of life and sexual function changes from before to 12 months after surgery using validated questionnaires.
Results:
Of the 480 participants in ULTRA, 49 underwent a combined lap-RFA and lap-MYO procedure between 2014 and 2022. The mean number of fibroids treated was 3.6 (standard deviation [SD] 2.0). The mean number of days to return to usual activities was 12.7 (SD 10.1). The Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire symptom severity score (0–100 points) improved by 36.4 points (SD 27.0, P < .001) at 12 months and the Sexual Health Outcomes in Women Questionnaire (0–100 points) assessment of pelvic problems interference with sex improved by 13 points (SD 34.4 P = .02) as early as 6 weeks. About 75% of women were satisfied with the surgery at 12 months.
Conclusion:
Combining lap-RFA and lap-MYO is associated with few peri-operative events, satisfactory recovery time, and significant improvement in quality-of-life measures with high patient satisfaction through 12 months after surgery.
Keywords: Abnormal uterine bleeding, Myomectomy, Pelvic pain, Radiofrequency ablation, Uterine fibroids
INTRODUCTION
Uterine fibroids are benign smooth muscle tumors estimated to occur in 70%–80% of women.1 Despite being common, they can cause debilitating symptoms and have a significant impact on quality of life.2 Symptoms of fibroids include irregular and or heavy bleeding, abdominal pain and bulk symptoms such as constipation, pelvic pressure and urinary frequency.3 The treatment of fibroids can be medical, interventional and surgical. Myomectomy is the gold standard uterine preserving surgical option, and whenever possible, a minimally invasive approach requires less pain medication, faster recovery, decreased intraoperative blood loss and shorter hospital stay compared to open myomectomy.4
Laparoscopic radiofrequency ablation (lap-RFA) of fibroids has gained popularity in recent years as another uterine preserving option for management of fibroids. It is an outpatient procedure that was United States Food and Drug Administration approved in 2012 for the treatment of fibroid related symptoms.5 The treatment is delivered laparoscopically and guided by intra-abdominal ultrasound (US) allowing most women returning to normal activities in 3–4 days.6
The heterogeneity of fibroid symptoms and disease burden necessitate individualized, tailored approach to treatment. Combining laparoscopic myomectomy (lap-MYO) and lap-RFA offers surgeons the possibility to optimize outcomes and successful symptom management without the constraints of a single technique. However, there is little information on outcomes after this combined approach. The aim of this study was to describe participant characteristics, surgical complications and quality of life outcomes after combined lap-RFA and lap-MYO.
METHODOLOGY
The Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) study is an IRB approved multicenter longitudinal study of lap-RFA. Starting in 2014, ULTRA enrolled women undergoing lap-RFA procedures at a single academic center and then expanded the study to other sites. In 2020, ULTRA also enrolled women undergoing planned lap-MYO or abdominal myomectomy to develop a uterine sparing surgical comparison group for lap-RFA. We describe a subgroup of ULTRA participants who underwent combined, simultaneous minimally invasive procedures of lap-RFA and lap-MYO.
Eligibility criteria for the ULTRA cohort included women who spoke English or Spanish who were scheduled to undergo lap-RFA ablation of fibroids or, starting in 2020, abdominal myomectomy or lap-MYO. Exclusion criteria included women less than 21 years old or those scheduled to undergo hysteroscopic myomectomy.
Participants of the study completed a baseline, preoperative assessment including questions regarding reproductive health, demographics, medical history and medication use. Preoperative imaging with US or magnetic resonance imaging (MRI) was used to document fibroid characteristics including size and number. We estimated total leiomyoma volume by summing the estimated spherical volume of each fibroid based on the available report dimensions using the following formula V = (4/3) * 3.14159 * (mean(fibroidsize A, fibroidsize B, fibroidsize C, etc.)/2).7 For uterine volume, we used the following formula V = 0.52 * (L * AP * T).8 Medical records provided peri-operative details including estimate blood loss, intraoperative complications, and length of hospital stay. The decision behind which fibroids were removed by lap-RFA and which were removed by lap-MYO was determined by each individual surgeon. To assess postoperative complications and recovery, ULTRA asked participants at 2 days, 1 week, three weeks and six weeks about prespecified or other adverse events (incisional, urinary tract or intraabdominal infections, deep vein thrombosis, blood transfusion, incisional hernia, or abnormal vaginal discharge) and to rate their postoperative pain on a scale from 0 to 10, report their use of pain medication and when they returned to their usual activities and work. At baseline and then at six weeks, three months, six months and 12 months after surgery, ULTRA assessed fibroid-related symptom impact and quality of life impact with the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) and sexual functioning with the Sexual Health Outcomes in Women (SHOW-Q) questionnaire. The UFS-QOL measures the domains of symptoms severity (higher scores indicated greater severity) and health related quality of life including activities, concern, control, energy/mood, self-consciousness, sexual function and overall (higher scores indicate better quality of life) and scores them from 0 to 100.9,10 The SHOW-Q measures 4 domains with scores ranging from 0 to 100.11 Orgasm frequency and quality was measured only in sexually active women and higher scores indicate better frequency and quality. Measured in all women, higher scores for pelvic problems interference with sex indicate worse interference whereas higher scores for sexual desire and satisfaction with sex indicate better sexual function. Finally, women were asked whether they were satisfied with their surgery and would recommend it to a friend at six weeks and 12 months.
We used descriptive statistics to report demographic and clinical characteristics of participants. Categorical variables were reported as counts and percentages. To assess, change from baseline in outcome measures, we used the Wilcoxon signed rank test. All statistical analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, NC), with P-value of <.05 considered statistically significant.
RESULTS
Demographics and Clinical Characteristics
Forty-nine participants enrolled in ULTRA (N = 480) underwent combined lap-RFA and lap-MYO between Apr 2015 to May 2022. Of the 49 participants, 45 (92%) contributed follow-up observations at 6 weeks and 41 (84%) contributed follow-up observations at 12 months. The mean age at enrollment was 40.4 (standard deviation [SD] 4.3) years with an average body mass index (BMI) of 30.0 (SD 7.2) (Table 1). Most women self-reported race as Black (N = 37, 76%) and White (N = 8,16%). Most women worked full time (N = 42, 86%) and had completed a college degree or higher education (N = 38, 78%). Most of the participants either had never given birth (N = 22, 45%), or had had 1–2 live births (N = 20, 40%). Preoperative imaging revealed an average of 3.5 (SD 2.0) fibroids with an average total fibroid volume of 161.2 (SD 150.4) cm3 and uterine volume of 519.5 (SD 345.4) cm3. Meanwhile, the average number and volume of fibroids noted with intraoperative laparoscopic US (LUS) was higher at 6.1 (SD 3.6) and a fibroid volume of 178.1 cm3 (SD 190.6).
Table 1.
Characteristics of Women Undergoing Combined Laparoscopic Radiofrequency Ablation of Fibroids and Laparoscopic Myomectomy in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study (2014–2022)
| Variable | |
|---|---|
| Age at enrollment | |
| Mean (SD) | 40.3 (4.3) |
| Median [IQR] | 40.0 [38.0–43.0] |
| Range | 31.0–50.0 |
| Body mass index (BMI) | |
| Mean (SD) | 30.0 (7.2) |
| Median [IQR] | 28.3 [24.1–34.3] |
| Range | 18.6–48.6 |
| Race or ethnicity, N (%) | |
| Black | 37 (76) |
| White | 8 (16) |
| Hispanic | 4 (9) |
| Asian | 2 (4) |
| Highest level of education, N (%) | |
| Some college or less | 10 (20) |
| College graduate (4 years BA or equivalent) | 15 (31) |
| Advanced degree | 23 (47) |
| Full time employment, N (%) | 42 (86) |
| Current relationship status | |
| Married or domestic partner | 15 (31) |
| Divorced/widowed/separated | 5 (10) |
| In a significant relationship | 12 (24) |
| Single | 17 (35) |
| Parity, N (%) | |
| 0 | 22 (45) |
| 1 | 10 (20) |
| 2 | 10 (20) |
| 3+ | 7 (14) |
| Symptoms reported as indications for surgery, N (%) | |
| Bleeding | 41 (85) |
| Pelvic pain/pressure/bloating | 41 (85) |
| Painful sex | 20 (42) |
| Urinary symptoms | 30 (63) |
| Constipation | 19 (40) |
| Fibroid characteristics—Preoperative | |
| Number of fibroids | |
| Mean (SD) | 3.5 (2.0) |
| Median [IQR] | 3.0 [2.0–5.0] |
| Range | 1.0–9.0 |
| Fibroid volume (cm3) | |
| Mean (SD) | 161.2 (150.4) |
| Median [IQR] | 112.5 [65.4–199.0] |
| Range | 5.5–661.9 |
| Uterine volume (cm3) | |
| Mean (SD) | 519.5 (345.4) |
| Median [IQR] | 477.9 [314.0–714.8] |
| Range | 87.9–2226.1 |
| Fibroid characteristics—Intraoperative | |
| Number of fibroids | |
| Mean (SD) | 6.1 (3.6) |
| Median [IQR] | 5.0 [3.0–8.0] |
| Range | 1.0–17.0 |
| Fibroid volume (cm3) | |
| Mean (SD) | 178.1 (190.6) |
| Median [IQR] | 94.1 [64.2–233.5] |
| Range | 7.6–988.6 |
N = 49 contributed characteristic data for all variables except as follows: preoperative uterine fibroid number and volume (N = 48) and uterine volume (N = 43). Abbreviations: IQR, intraquartile range; SD, standard deviation.
Perioperative Outcomes and Complications
The median estimated blood loss was 54.9 (SD 63.8) cc. One participant reported an intraoperative blood transfusion and five reported overnight hospitalization for observation. No women reported complications at 2 days after their surgery. One participant reported a wound infection at seven days. Three participants reported minor infections (1 bladder and 2 uterine infections) necessitating the use of antibiotics. One participant reported heavy vaginal bleeding with anemia at six weeks requiring surgical intervention of a myomectomy. The most commonly reported symptom in the six weeks after surgery was vaginal discharge and spotting.
Pain and Reported Opioid Use
The mean self-reported pain score (0–10) fell from 5.4 at 2 days to 1.9 at 3 weeks and 1.4 at 6 weeks. Mirroring this, reported opioid use fell from 60% at 2 days to 7% at 3 weeks and 5% at 6 weeks (Figure 1).
Figure 1.
Percent of women using opioid pain medication and average self-reported pain score with 95% confidence intervals* by weeks after combined laparoscopic radio-frequency ablation and myomectomy surgery in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study (2014–2022).
Return to Usual Activities and Work
Return to work and usual activities were similar across time from baseline to 6 weeks following surgery (Figure 2). By 20 days, 85% of participants reported returning to usual activities and 83% reported returning to work. The mean number of days for returning to usual activities was 12.4 (SD 10.1) and returning to work was 13.7 (SD 9.8).
Figure 2.
Percent of women reporting return to usual activities and work with 95% confidence intervals* by days after combined laparoscopic radio-frequency ablation and myomectomy surgery in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) study (2014–2022).
Quality of Life
The mean USF-QOL symptom severity score improved from baseline (−9.9, SD 24.4) starting as early as six weeks after the combined procedure. For all other domains of the UFS-QOL, improvement started at the three-month postoperative evaluation and was greatest at 12 months after the combined procedure (Table 2). For example, mean reduction in symptom severity was −37.7 (SD 26.3) points and increase in overall quality of life was 36.6 (SD 29.8) points from before to 12 months after surgery.
Table 2.
Participant Survey Results from the Uterine Fibroid Symptom & Health-Related Quality of Life Questionnaire (UFS-QOL)18 in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study (2014–2022)
| Baseline |
Follow-Up |
Change† |
||
|---|---|---|---|---|
| Variable | Mean Score (SD) |
Mean Score (SD) |
Mean Change (SD) |
P-Value§ |
| Baseline (N = 49) | ||||
| Symptom severity | 63.8 (22.1) | |||
| Overall QOL score¶ | 39.9 (25.2) | |||
| Activities | 41.9 (29.3) | |||
| Concern | 29.9 (30.5) | |||
| Control | 41.7 (29.2) | |||
| Energy/mood | 43.4 (26.3) | |||
| Self-consciousness | 36.2 (31.1) | |||
| Sexual function | 46.2 (32.9) | |||
| 6 Week postoperative visit (N = 45) | ||||
| Symptom severity | 63.0 (21.9) | 52.1 (24.4) | −10.9 (24.8) | .01 |
| Overall QOL score¶ | 40.3 (24.8) | 44.7 (24.1) | 4.3 (20.6) | .16 |
| Activities | 42.5 (29.6) | 46.3 (27.0) | 3.8 (23.9) | .39 |
| Concern | 30.2 (29.8) | 36.6 (28.7) | 6.3 (22.0) | .03 |
| Control | 42.6 (28.2) | 48.6 (29.0) | 6.1 (25.8) | .04 |
| Energy/mood | 43.7 (26.7) | 46.5 (27.9) | 2.8 (21.9) | .55 |
| Self-consciousness | 36.3 (30.4) | 42.2 (27.1) | 5.9 (28.0) | .05 |
| Sexual function | 46.7 (33.1) | 46.7 (31.8) | 0.0 (36.6) | .76 |
| 3 Month postoperative visit (N = 42) | ||||
| Symptom severity | 61.8 (22.0) | 28.9 (22.5) | −33.0 (29.4) | <.0001 |
| Overall QOL score¶ | 41.9 (25.1) | 72.5 (28.0) | 30.6 (32.0) | <.0001 |
| Activities | 43.9 (29.0) | 74.6 (29.6) | 30.7 (35.0) | <.0001 |
| Concern | 33.0 (31.3) | 68.5 (33.2) | 35.5 (34.0) | <.0001 |
| Control | 43.9 (29.1) | 75.4 (28.7) | 31.4 (36.7) | <.0001 |
| Energy/mood | 44.9 (26.8) | 74.2 (27.7) | 29.3 (31.8) | <.0001 |
| Self-consciousness | 38.1 (31.1) | 70.0 (30.8) | 31.9 (40.3) | <.0001 |
| Sexual function | 47.3 (32.4) | 65.2 (36.3) | 17.9 (41.4) | .0068 |
| 6 Month postoperative visit (N = 41) | ||||
| Symptom Severity | 60.7 (22.0) | 24.5 (18.5) | −36.3 (27.0) | <.0001 |
| Overall QOL score¶ | 42.7 (26.1) | 78.0 (22.7) | 35.4 (27.2) | <.0001 |
| Activities | 45.2 (30.0) | 80.7 (23.7) | 35.5 (28.9) | <.0001 |
| Concern | 34.3 (31.5) | 74.6 (28.0) | 40.4 (32.0) | <.0001 |
| Control | 44.5 (30.0) | 79.9 (23.7) | 35.4 (32.6) | <.0001 |
| Energy/mood | 44.8 (27.8) | 79.9 (22.7) | 35.1 (27.7) | <.0001 |
| Self-consciousness | 40.0 (32.0) | 73.0 (25.3) | 32.9 (34.9) | <.0001 |
| Sexual function | 47.0 (34.1) | 73.8 (28.8) | 26.8 (39.7) | <.0001 |
| 12 Month postoperative visit (N = 41) | ||||
| Symptom severity | 61.0 (22.2) | 24.6 (19.7) | −36.4 (24.7) | <.0001 |
| Overall QOL score¶ | 41.5 (25.2) | 76.5 (23.7) | 35.0 (29.4) | <.0001 |
| Activities | 44.3 (28.8) | 80.9 (24.0) | 36.6 (31.2) | <.0001 |
| Concern | 31.6 (31.0) | 72.0 (30.3) | 40.4 (31.5) | <.0001 |
| Control | 43.7 (29.3) | 79.8 (23.8) | 36.1 (33.8) | <.0001 |
| Energy/mood | 44.3 (27.1) | 77.3 (24.1) | 33.0 (31.2) | <.0001 |
| Self-consciousness | 38.6 (30.5) | 70.7 (26.9) | 32.1 (37.5) | <.0001 |
| Sexual function | 45.1 (33.2) | 70.4 (28.2) | 25.3 (38.7) | .0001 |
†Change is calculated as follow-up value minus baseline value; §Signed Rank test. Symptom severity: scores range from 0 to 100, higher scores indicate greater severity. ¶UFS-QOL Overall score and domain scores (concern, activities, energy/mood, control, self-consciousness, sexual function): range from 0 to 100, higher score indicates better quality of life. Abbreviation: SD, standard deviation.
Satisfaction
By six weeks after surgery, 37 (82%) patients expressed that they were satisfied with the combined lap-RFA and lap-MYO procedure, 41 (91%) would recommend it to friends, and 42 (93%) felt it was effective in eliminating fibroid symptoms. When considering longevity of satisfaction, 32 (78%) patients remained satisfied, 31 (76%) would recommend it to friends, and 30 (73%) felt it was effective in eliminating symptoms at 12 months.
Sexual Function
Overall, SHOW-Q scores in the domains of interference with sex, sexual desire, and satisfaction with sex improved from baseline at 3, 6, and 12 months of follow-up (Table 3). However, perceptions of pelvic problem interfering with sex was the only domain to significantly improve by 6 weeks after treatment with a mean change of −13.0 (SD 34.4, P = .02). The only domain that did not demonstrate significant improvement by 12 months postprocedure for women who were sexually active was orgasm frequency and quality.
Table 3.
Participant Survey Results from the Sexual Health Outcomes in Women Questionnaire (SHOW-Q)11 in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study (2014–2022)
| Baseline |
Follow-Up |
Change† |
|||
|---|---|---|---|---|---|
| Meanǂ | Meanǂ | Meanǂ | |||
| Variable | N | (SD) | (SD) | (SD) | P-Value‖ |
| Baseline | |||||
| Orgasm frequency and quality scale¶ | 38 | 55.2 (28.0) | |||
| Pelvic problem interference with sex# | 48 | 38.5 (32.5) | |||
| Sexual desire** | 48 | 45.7 (33.1) | |||
| Satisfaction with sex** | 47 | 49.5 (32.8) | |||
| 6 Week postoperative visit | |||||
| Orgasm frequency and quality scale¶ | 22 | 58.5 (22.7) | 62.6 (26.3) | 4.1 (17.1) | .21 |
| Pelvic problem interference with sex# | 43 | 40.1 (31.4) | 27.1 (29.3) | −13.0 (34.4) | .02 |
| Sexual desire** | 43 | 48.1 (32.4) | 52.1 (29.6) | 4.1 (31.6) | .33 |
| Satisfaction with sex** | 41 | 49.4 (31.9) | 56.7 (29.7) | 7.3 (31.4) | .20 |
| 3 Month postoperative visit | |||||
| Orgasm frequency and quality scale¶ | 30 | 55.9 (26.3) | 65.0 (25.2) | 9.1 (21.4) | .02 |
| Pelvic problem interference with sex# | 41 | 40.4 (30.8) | 14.8 (20.7) | −25.6 (33.7) | <.0001 |
| Sexual desire** | 41 | 49.7 (30.8) | 57.6 (25.5) | 7.9 (32.3) | .15 |
| Satisfaction with sex** | 40 | 50.9 (32.7) | 67.8 (28.0) | 16.9 (35.9) | .0026 |
| 6 Month postoperative visit | |||||
| Orgasm frequency and quality scale¶ | 28 | 60.7 (22.6) | 66.4 (22.5) | 5.7 (23.7) | .22 |
| Pelvic problem interference with sex# | 39 | 37.2 (32.2) | 12.0 (15.9) | −25.2 (33.6) | <.0001 |
| Sexual desire** | 39 | 48.6 (31.1) | 62.4 (26.8) | 13.8 (29.4) | .0079 |
| Satisfaction with sex** | 38 | 52.0 (33.6) | 70.4 (23.0) | 18.4 (35.0) | .0029 |
| 12 Month postoperative visit | |||||
| Orgasm frequency and quality scale¶ | 30 | 60.2 (22.2) | 62.9 (24.9) | 2.7 (21.8) | .57 |
| Pelvic problem interference with sex¶ | 40 | 36.0 (31.4) | 15.0 (16.5) | −21.0 (33.2) | <.0001 |
| Sexual desire# | 40 | 47.5 (31.9) | 64.0 (29.5) | 16.5 (33.3) | .0046 |
| Satisfaction with sex** | 39 | 51.0 (32.9) | 69.2 (25.0) | 18.3 (36.6) | .0031 |
†Change calculated as follow-up value minus baseline value. ǂSHOW-Q scores range from 0 to 100. ‖Signed Rank test. ¶Orgasm measured only in sexually active women: higher scores indicate better orgasm frequency and quality. #Pelvic problem interference with sex: higher scores indicate worse interference. **Sexual desire and satisfaction: higher scores indicate better sexual function. Abbreviation: SD, standard deviation.
DISCUSSION/CONCLUSIONS
Treatment options offered by gynecological surgeons available to women with fibroids have long been limited to hysterectomy, myomectomy, and endometrial ablation. With the more recent addition of lap-RFA, women who desire uterine sparing procedures have an additional option, but there may be times when combined treatments will allow better control of symptoms. Our prospective cohort study over 12 months demonstrates that combining lap-RFA and lap-MYO simultaneously had few peri-operative events, satisfactory recovery, as well as improved symptom severity, quality of life and sexual functioning by three months that was durable through 12 months postoperatively.
One of the great benefits of minimally invasive surgery is fewer complications, less postoperative pain and a faster return to work and normal activities compared to open surgery. In our 49 women, we identified few complications and found that our participants reported satisfactory recovery times. For example, the trajectory of opioid medication use was similar to other benign gynecological procedures; a little more than half used opioid pain medication in the first few days of surgery but dropped rapidly to 5% after 6 weeks similar to previous studies of benign hysterectomy.12 Full return to usual activities and work by 3 weeks in our study was similar to that reported for lap-MYO alone, suggesting that the addition of lap-RFA did not considerably increase recovery time in our 49 participants.13
Absolute fibroid reduction can be difficult to achieve during lap-MYO due to reduced tactile feedback and visualization when compared to open abdominal approaches. While preoperative imaging is customary prior to myomectomy, not all fibroids may be detected, even with MRI. For example, there may be as much as a 65% increase in the number of fibroids detected on LUS compared to preoperative US and MRI.14–16 We report similar findings as total fibroid burden was higher when LUS was used compared to those reported on preoperative imaging. As RFA utilizes LUS, combining this procedure with lap-MYO may allow surgeons to have the benefit of increasing the number fibroids treated during surgery, leading to greater effectiveness and durability of treatment.
We found that women who underwent combined lap-RFA and lap-MYO reported improvement in many aspects of their lives as early as three months including symptom severity, quality of life and sexual functioning. These improvements persisted through the 12 months of follow-up. While we are not able to report objective results of the treatment nor able to compare effectiveness with other treatments, improvement on validated questionnaires combined with subjective reporting of high satisfaction with the surgery that our participants would recommend to friends suggests that treating fibroids with a combined procedure is effective for symptom improvement and emotional satisfaction. The most likely explanation is that reducing fibroid volume through shrinkage and excision together were important for these quality of life improvements and procedural satisfaction.
Our study has a number of strengths. First, over 60% of the women recruited were Black, representing an understudied population who is more impacted by uterine fibroids than other racial or ethnic groups.17 Similarly, ULTRA had a high representation of nulliparous women, likely because of the study’s focus on uterine sparing procedures. Second, we prospectively followed women across multiple time points from before their fibroid procedure to 1 year after with good retention (84%), thus reducing recall and attrition bias that are often associated with overestimating satisfaction and effectiveness. Third, ULTRA was multicenter study, including both academic centers and private practices making our results generalizable to multiple types of clinical practice.
Our study also had a few limitations. First, this is a small study without a comparison arm to assess effectiveness of combining lap-RFA and lap-MYO to each alone or other uterine sparing procedures. However, there is little data on this combined approach and the indications for combining the procedures in the same surgery–such as a unique type of fibroid burden–likely make our participants different from those undergoing lap-RFA or lap-MYO alone. Second, we have few objective measures of operative outcomes (e.g., follow-up imaging and records of health care utilization after the procedure), however, our use of standardized quality of life and sexual function measures for fibroids surgery provides comparability with many other fibroid outcome studies.
In conclusion, combining lap-RFA and lap-MYO appears to be associated with few peri-operative events, satisfactory recovery time, and significant improvement in quality of life measures with high patient satisfaction through 12 months after surgery.
Footnotes
Acknowledgments: Study Sites: University of California, San Francisco—V.J., PI 2013–present; University of California, Davis—L.E.W., PI 2013–present; University of California, Los Angeles—Ram Parvataneni, PI 2013–present; University of California, Irvine—Naghmeh Salamat-Saberi, PI 2013–present; University of California, San Diego—Shira Varon, PI 2013–present; University of Texas Southwestern Medical Center—K.A.K., PI 2018–present; MacArthur Medical Center—Brian Enggano, PI 2018–present; Gynecological Institute of Chicago—Nicole Williams, PI 2018–present; Fibroid Pelvic and Wellness Center of Georgia—Soyini Hawkins, PI 2019–present; Dedicated to Women—Robert B. Hartmann, PI 2019–present; Acacia OB/Gyn—Henry Garza, PI 2019–present; Womens Healthcare Associate of Illinois, SC—Biren Shah, PI 2019–present; Duke University—Craig J. Sobolewski, PI 2020–present; Tassone Advanced OB/Gyn—Shawn Tassone, PI 2020–present; Alamo OB/Gyn—Rene Perez, PI 2021–present. We thank the study staff at each site and all the women who participated in ULTRA.
Conflict of interests: none.
Disclosure: none.
Funding sources: This research was funded in part by a grant from Hologic, Inc (formerly ACESSA Health); however, the funder had no role in the design and conduct of this analysis; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Clinical trial registry number: NCT02100904.
IRB approval: April 24, 2014 #14-13325 University of California, San Francisco Institutional Review board.
Data availability: Data are available from the authors upon reasonable request.
Contributor Information
Emily A. Sendukas, Department of Obstetrics & Gynecology, Division of Minimally Invasive Gynecologic Surgery, University of Texas Medical Branch, Galveston, Texas, USA. (Dr. Sendukas).
Jessica K. Shields, Department of Surgery, Division of Gynecology, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA. (Dr. Shields).
Kimberly A. Kho, Division of Advanced Gynecology University of Hawaii, Honolulu, Hawaii, USA. (Dr. Kho).
Marisa Latham, Department of Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas, USA. (Dr. Latham).
Vanessa Jacoby, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, USA. (Drs. Jacoby and Schembri).
Michael Schembri, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, USA. (Drs. Jacoby and Schembri).
L. Elaine Waetjen, Department of Obstetrics and Gynecology, University of California, Davis, California, USA. (Dr. Waetjen).
References:
- 1.Yang Q, Ciebiera M, Bariani MV, et al. Comprehensive review of uterine fibroids: developmental origin, pathogenesis, and treatment. Endocr Rev. 2022;43(4):678–719. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Marsh EE, Al-Hendy A, Kappus D, Galitsky A, Stewart EA, Kerolous M. Burden, prevalence, and treatment of uterine fibroids: a survey of U.S. women. J Womens Health. 2018;27(11):1359–1367. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Womens Health. 2012;12:6. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Cardozo ER, Clark AD, Banks NK, Henne MB, Stegmann BJ, Segars JH. The estimated annual cost of uterine leiomyomata in the United States. Am J Obstet Gynecol. 2012;206(3):211.e1–e9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Lee BB, Issacson KB, Diamond MP. Radiofrequency volumetric thermal ablation of symptomatic uterine fibroids: The Acessa procedure. Leiomyomas. 2015;175–193. [Google Scholar]
- 6.Stewart KA, Greenberg JA, Kho KA, Cohen Rassier SL. Radiofrequency ablation of leiomyomas. Obstet Gynecol. 2023;141(6):1063–1071. [DOI] [PubMed] [Google Scholar]
- 7.Quinn SD, Vedelago J, Kashef E, Gedroyc W, Regan L. Measurement of uterine fibroid volume: a comparative accuracy and validation of methods study. Eur J Obstet Gynecol Reprod Biol. 2013;171(1):161–165. [DOI] [PubMed] [Google Scholar]
- 8.Goldstein SR, Horii SC, Snyder JR, Raghavendra BN, Subramanyam B. Estimation of nongravid uterine volume based on a nomogram of gravid uterine volume: its value in gynecologic uterine abnormalities. Obstet Gynecol. 1988;72(1):86–90. [PubMed] [Google Scholar]
- 9.Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. Curr Med Res Opin. 2017;33(2):193–200. [DOI] [PubMed] [Google Scholar]
- 10.Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002;99(2):290–300. [DOI] [PubMed] [Google Scholar]
- 11.Learman LA, Huang AJ, Nakagawa S, Gregorich SE, Kuppermann M. Development and validation of a sexual functioning measure for use in diverse women’s health outcome studies. Am J Obstet Gynecol. 2008;198(6):710.e1–8; discussion 710.e8–9. [DOI] [PubMed] [Google Scholar]
- 12.Hessami K, Welch J, Frost A, et al. Perioperative opioid dispensing and persistent use after benign hysterectomy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2023;229(1):23–32.e3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Laughlin-Tommaso SK, Lu D, Thomas L, et al. Short-term quality of life after myomectomy for uterine fibroids from the COMPARE-UF Fibroid Registry. Am J Obstet Gynecol. 2020;222(4):345.e1–e22. [DOI] [PubMed] [Google Scholar]
- 14.Patel HH, Banerjee D, Goldrath K, et al. Intraoperative laparoscopic ultrasound increases fibroid detection during laparoscopic myomectomy. JSLS. 2022;26(3):e2022.00038. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Shimanuki H, Takeuchi H, Kikuchi I, Kumakiri J, Kinoshita K. Effectiveness of intraoperative ultrasound in reducing recurrent fibroids during laparoscopic myomectomy. J Reprod Med. 2006;51(9):683–688. [PubMed] [Google Scholar]
- 16.Bent RE, Wilson MD, Jacoby VL, et al. Myoma imaging by gynecologic surgeons training in intraoperative ultrasound technique. J Minim Invasive Gynecol. 2019;26(6):1139–1143. [DOI] [PubMed] [Google Scholar]
- 17.Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44(1):81–94. [DOI] [PubMed] [Google Scholar]
- 18.Harding G, Coyne KS, Thompson CL, Spies JB. The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL). Health Qual Life Outcomes. 2008;6:99–94. [DOI] [PMC free article] [PubMed] [Google Scholar]