Volume 200, Issue 5 , Pages e21-e23, May 2009
Patient satisfaction with thermal balloon ablation for treatment of menorrhagia
Article Outline
Objective
The purpose of this study was to determine whether satisfaction in women who have undergone the thermal balloon ablation (TBA) procedure for menorrhagia at the Penn State Milton S. Hershey Medical Center is consistent with initial published studies.
Study Design
Two hundred sixteen patients were mailed a survey regarding patient satisfaction, postoperative bleeding patterns, and need for additional surgery. The follow-up interval was 13-60 months.
Results
The survey response rate was 88%. Eighty-nine percent of women were satisfied with the results of their procedure. After 3-5 years, 37% of women reported amenorrhea and 44% reported minimal/light bleeding. Only 9% of women eventually required hysterectomy.
Conclusion
This study confirms a patient satisfaction rate in our institution that is consistent with initial published studies.
Key words: patient satisfaction, thermal balloon ablation, treatment of menorrhagia
Menorrhagia is a gynecological problem that affects approximately 20% of women and accounts for a significant number of office visits each year. It can be managed in a variety of ways, both medically and surgically, but hysterectomy is considered the definitive surgical treatment. Such an invasive procedure, however, is not always feasible or desired. Many endometrial ablation techniques have been developed and improved, providing women with more conservative surgical options.1
The Thermachoice system, developed by Gynecare, was the first global technique to be approved by the Food and Drug Administration.2 Many comparative studies have shown it to be as effective as hysteroscopic ablation techniques.3, 4 Early studies report the patient satisfaction rate of the thermal balloon ablation (TBA) to be approximately 85%.5, 6 More recent retrospective studies, however, have reported much lower rates of patient satisfaction; in 1 case, 40% of women were dissatisfied enough to pursue hysterectomy within 2 years of the TBA procedure.7
This study was undertaken to compare patient satisfaction in women who have undergone the TBA procedure at the Hershey Medical Center in the past 5 years with initial published reports.
Materials and Methods
Before the onset of data collection, approval was obtained from the institutional review board to survey all patients who underwent the TBA procedure at the Hershey Medical Center between January 1, 2001 and December 31, 2004. All TBA procedures at the Hershey Medical Center were done under the guidance of experienced senior medical staff, and patients routinely had a concomitant fractional dilation and curettage. Two hundred sixteen women underwent the procedure during this time and were included in this study. See Table 1 for patient demographics. Our primary outcome measure in this study was patient satisfaction with the TBA procedure at our institution. Secondary outcome measures included postprocedure bleeding patterns and need for additional surgical interventions.
TABLE 1. Patient demographics
| Patient characteristics | Median | Range |
|---|---|---|
| Age (y) | 42 | 25-73 |
| Height (in) | 66 | 58-71 |
| Weight (lb) | 150 | 100-353 |
| Gravity | 2 | 0-9 |
| Parity | 2 | 0-6 |
| Smokers | Yes | No |
30 (17%) | 147(83%) | |
| Ethnicity | ||
| White | 159(91%) | |
| African American | 6(3.4%) | |
| Hispanic | 4(2.3%) | |
| Asian | 2(1%) | |
| Othera | 4(2.3%) |
aPacific Islander, Greek American Indian. |
Our study patients received a 2-page written survey by mail that included questions about patient demographics, surgery date, indication, and medical or surgical therapy received prior to the TBA procedure. They were also asked to rate their satisfaction, quantify their menstrual bleeding since the procedure, and comment on any additional surgical procedures. Up to 3 reminder postcards were mailed to those who had not returned their surveys. All mailings and data collection were done by the Survey Research Center at University Park, State College, PA. Surveys received by January 1, 2006, were included in the analysis representing a 13-60 month follow-up interval for all cases.
Results
Two hundred sixteen surveys were mailed initially, but 14 were ultimately determined undeliverable due to incorrect address. Of the 202 surveys received by patients, 178 patients (88%) participated by completing their surveys in the allotted time.
Of all patients surveyed, 158 (89%) reported they were satisfied or very satisfied with the procedure results and would recommend the procedure to a friend or family member. The patients who were dissatisfied ranged in age from 26-53 with a median age of 44 years, which is representative of the entire sample. In the cohort of patients who underwent the procedure prior to 2003, 57 (92%) were satisfied (Table 2).
TABLE 2. Patient satisfaction 1-5 years postablation
| Variable | 3-5 year follow-up n = 62 | All patientsN = 178 |
|---|---|---|
| Satisfied | 57(92%) | 158(89%) |
| Not satisfied | 5(8%) | 20(11%) |
Seventy (40%) women reported amenorrhea after the procedure, 68 (39%) reported minimal or light bleeding, 26 (15%) reported moderate bleeding, and only 13 (7%) reported persistent heavy or worsened bleeding. These numbers are consistent in the subgroup that underwent the procedure more than 3 years ago (Table 3).
TABLE 3. Menstrual status of patients 1-5 years postablation
| Variable | 3-5 year follow-up n = 62 | All patients N = 177a |
|---|---|---|
| Amenorrhea | 23(37%) | 70(40%) |
| Minimal/light bleeding | 27(44%) | 68(39%) |
| Moderate bleeding | 8(13%) | 26(15%) |
| Menorrhagia/heavy bleeding | 4(6%) | 13(7%) |
aOne patient did not answer the question. |
Sixteen (9%) of our patients went on to have a hysterectomy after the TBA procedure, 7 (4%) had a dilation and curettage (D&C), and 4 (2%) underwent repeat TBA (Table 4). Of the 27 patients who indicated they had additional surgery following the TBA, 17 reported they were still satisfied with the initial procedure.
TABLE 4. Postablation procedures
| Variable | All patients N = 178 |
|---|---|
| Hysterectomy | 16(9%) |
| D&C | 7(4%) |
| Repeat TBA | 4(2%) |
Comment
Endometrial ablation is an attractive treatment option to offer patients suffering from menorrhagia who would like to avoid hysterectomy. However, review of the literature addressing patient satisfaction with the TBA, postprocedure bleeding patterns, and need for additional surgery reveals a wide variation in results. Many of the studies are small and the follow-up time is short. This makes counseling patients who are considering TBA for treatment difficult.
In our study, we had an excellent response rate to our survey, with 88% of our patients completing and returning the survey. We were able to analyze results covering a significant postoperative follow-up time frame (13-60 months). Our results are consistent with other TBA studies that report medium and long-term satisfaction rates of 70-90%, proving the validity of the survey questions asked.5, 8, 9, 10
Regarding bleeding patterns after the TBA procedure, our reported amenorrhea rate was 40%. In the cohort of women 3-5 years after the procedure, the amenorrhea rate was well maintained at 37%. In addition, another 39% of our patients reported only minimal to light bleeding. That rate was 44% when analyzed as a cohort 3-5 years postprocedure.
In conclusion, this study confirms that patient satisfaction with TBA is high, and we believe this is related to the reduced menstrual flow after the procedure. The results of this study will help physicians set patient expectations appropriately regarding satisfaction with the TBA, success in reducing menstrual flow, and potential need for additional surgery.
References
- . Global endometrial ablation technologies. Obstet Gynecol Clin North Am. 2000;27:385–396
- . The endometrial ablator: a new instrument. Obstet Gynecol. 1994;83:792–796
- . Microwave and thermal balloon ablation for heavy menstrual bleeding: a systematic review. BJOG. 2005;112:12–23
- . Efficacy and satisfaction rate comparing endometrial ablation by rollerball electrocoagulation to uterine balloon thermal ablation in a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2004;114:97–103
- . Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998;92:98–103
- . Clinical trial of the uterine thermal balloon for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 1997;4:559–565
- . Patient satisfaction with thermal balloon endometrial ablation (A retrospective review). J Reprod Med. 2003;48:635–636
- Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicentre follow-up study. Hum Reprod. 2003;18:1082–1087
- . Hysteroscopic transcervical endometrial resection versus thermal destruction for menorrhagia: a prospective randomized trial on satisfaction rate. Am J Obstet Gynecol. 2002;187:545–550
- . The medium- and long-term outcome of endometrial ablative techniques. Eur J Obstet Gynecol Reprod Biol. 2005;121:233–235
This study was supported by an educational Grant from Ethicon Women's Health and Urology.
PII: S0002-9378(08)01043-0
doi:10.1016/j.ajog.2008.09.006
© 2009 Mosby, Inc. All rights reserved.
Volume 200, Issue 5 , Pages e21-e23, May 2009
