Laparoscopic radiofrequency fibroid ablation: Phase ii and phase iii results

Donald I. Galen, Rodolfo Robles Pemueller, José Gerardo Garza Leal, Karen R. Abbott, Janice Lynn Falls, James Macer

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background and Objectives: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). Methods: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasoundguided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P<.001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P <.001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P =.008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related qualityof- life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural devicerelated adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. Conclusions: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

Original languageEnglish (US)
Pages (from-to)182-190
Number of pages9
JournalJournal of the Society of Laparoendoscopic Surgeons
Volume18
Issue number2
DOIs
StatePublished - 2014

Fingerprint

Leiomyoma
Myoma
Hot Temperature
Quality of Life
Matched-Pair Analysis
Outpatients
Hemorrhage
Equipment and Supplies
Pregnancy
Health
Therapeutics

Keywords

  • Fibroid
  • Laparoscopic ultrasound
  • Laparoscopy
  • Myoma
  • Radiofrequency ablation

ASJC Scopus subject areas

  • Surgery

Cite this

Laparoscopic radiofrequency fibroid ablation : Phase ii and phase iii results. / Galen, Donald I.; Pemueller, Rodolfo Robles; Leal, José Gerardo Garza; Abbott, Karen R.; Falls, Janice Lynn; Macer, James.

In: Journal of the Society of Laparoendoscopic Surgeons, Vol. 18, No. 2, 2014, p. 182-190.

Research output: Contribution to journalArticle

Galen, Donald I. ; Pemueller, Rodolfo Robles ; Leal, José Gerardo Garza ; Abbott, Karen R. ; Falls, Janice Lynn ; Macer, James. / Laparoscopic radiofrequency fibroid ablation : Phase ii and phase iii results. In: Journal of the Society of Laparoendoscopic Surgeons. 2014 ; Vol. 18, No. 2. pp. 182-190.
@article{5f4517b41f52478e8b131a68a3ba72a3,
title = "Laparoscopic radiofrequency fibroid ablation: Phase ii and phase iii results",
abstract = "Background and Objectives: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). Methods: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasoundguided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P<.001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P <.001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P =.008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4{\%} (1 of 69). In the phase III study, approximately 98{\%} of patients were assessed at 12 months, and their transformed symptom severity scores, health-related qualityof- life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural devicerelated adverse events was 3.5{\%} (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. Conclusions: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.",
keywords = "Fibroid, Laparoscopic ultrasound, Laparoscopy, Myoma, Radiofrequency ablation",
author = "Galen, {Donald I.} and Pemueller, {Rodolfo Robles} and Leal, {Jos{\'e} Gerardo Garza} and Abbott, {Karen R.} and Falls, {Janice Lynn} and James Macer",
year = "2014",
doi = "10.4293/108680813X13693422518353",
language = "English (US)",
volume = "18",
pages = "182--190",
journal = "Journal of the Society of Laparoendoscopic Surgeons",
issn = "1086-8089",
publisher = "Society of Laparoendoscopic Surgeons",
number = "2",

}

TY - JOUR

T1 - Laparoscopic radiofrequency fibroid ablation

T2 - Phase ii and phase iii results

AU - Galen, Donald I.

AU - Pemueller, Rodolfo Robles

AU - Leal, José Gerardo Garza

AU - Abbott, Karen R.

AU - Falls, Janice Lynn

AU - Macer, James

PY - 2014

Y1 - 2014

N2 - Background and Objectives: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). Methods: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasoundguided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P<.001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P <.001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P =.008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related qualityof- life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural devicerelated adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. Conclusions: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

AB - Background and Objectives: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). Methods: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasoundguided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P<.001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P <.001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P =.008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related qualityof- life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural devicerelated adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. Conclusions: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

KW - Fibroid

KW - Laparoscopic ultrasound

KW - Laparoscopy

KW - Myoma

KW - Radiofrequency ablation

UR - http://www.scopus.com/inward/record.url?scp=84902951074&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84902951074&partnerID=8YFLogxK

U2 - 10.4293/108680813X13693422518353

DO - 10.4293/108680813X13693422518353

M3 - Article

C2 - 24960480

AN - SCOPUS:84902951074

VL - 18

SP - 182

EP - 190

JO - Journal of the Society of Laparoendoscopic Surgeons

JF - Journal of the Society of Laparoendoscopic Surgeons

SN - 1086-8089

IS - 2

ER -