Intrauterine fluid instillation to confirm tubal occlusion after transcervical permanent contraception: A pilot study,

Eva Patil, Amy Thurmond, Kyle Hart, Jacqueline Seguin, Alison Edelman, Jeffrey T. Jensen

Research output: Contribution to journalArticle

Abstract

Objectives: To determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter. Study design: In this prospective cohort pilot study, we enrolled women with prior Essure® procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure®. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses. Results: We recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure® subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8 mL (7.4, 8.4)] larger than post-Essure® participants [2.2 mL (2.0, 3.8), p < 0.01]. While 50% of control subjects tolerated the full 10 mL of fluid instillation, none of the post-Essure® subjects tolerated this volume (p = 0.03). A combination of saline loss ≤4 mL and participant intolerance of the full 10 mL volume yielded sensitivity of 0.80 (95% CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion. Conclusion: Instillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations. Implications: Confirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure® from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Tubal Sterilization
Contraception
Catheters
Infusion Pumps
Intrauterine Devices
Uterus
Cohort Studies
Pressure
Sensitivity and Specificity
Population

Keywords

  • Intrauterine fluid loss
  • Nonsurgical permanent contraception
  • Sensitivity
  • Specificity
  • Sterilization
  • Transcervical permanent contraception
  • Tubal occlusion verification

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Intrauterine fluid instillation to confirm tubal occlusion after transcervical permanent contraception : A pilot study,. / Patil, Eva; Thurmond, Amy; Hart, Kyle; Seguin, Jacqueline; Edelman, Alison; Jensen, Jeffrey T.

In: Contraception, 01.01.2019.

Research output: Contribution to journalArticle

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abstract = "Objectives: To determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter. Study design: In this prospective cohort pilot study, we enrolled women with prior Essure{\circledR} procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure{\circledR}. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses. Results: We recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure{\circledR} subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8 mL (7.4, 8.4)] larger than post-Essure{\circledR} participants [2.2 mL (2.0, 3.8), p < 0.01]. While 50{\%} of control subjects tolerated the full 10 mL of fluid instillation, none of the post-Essure{\circledR} subjects tolerated this volume (p = 0.03). A combination of saline loss ≤4 mL and participant intolerance of the full 10 mL volume yielded sensitivity of 0.80 (95{\%} CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion. Conclusion: Instillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations. Implications: Confirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure{\circledR} from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.",
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AU - Patil, Eva

AU - Thurmond, Amy

AU - Hart, Kyle

AU - Seguin, Jacqueline

AU - Edelman, Alison

AU - Jensen, Jeffrey T.

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Y1 - 2019/1/1

N2 - Objectives: To determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter. Study design: In this prospective cohort pilot study, we enrolled women with prior Essure® procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure®. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses. Results: We recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure® subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8 mL (7.4, 8.4)] larger than post-Essure® participants [2.2 mL (2.0, 3.8), p < 0.01]. While 50% of control subjects tolerated the full 10 mL of fluid instillation, none of the post-Essure® subjects tolerated this volume (p = 0.03). A combination of saline loss ≤4 mL and participant intolerance of the full 10 mL volume yielded sensitivity of 0.80 (95% CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion. Conclusion: Instillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations. Implications: Confirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure® from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.

AB - Objectives: To determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter. Study design: In this prospective cohort pilot study, we enrolled women with prior Essure® procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure®. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses. Results: We recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure® subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8 mL (7.4, 8.4)] larger than post-Essure® participants [2.2 mL (2.0, 3.8), p < 0.01]. While 50% of control subjects tolerated the full 10 mL of fluid instillation, none of the post-Essure® subjects tolerated this volume (p = 0.03). A combination of saline loss ≤4 mL and participant intolerance of the full 10 mL volume yielded sensitivity of 0.80 (95% CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion. Conclusion: Instillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations. Implications: Confirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure® from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.

KW - Intrauterine fluid loss

KW - Nonsurgical permanent contraception

KW - Sensitivity

KW - Specificity

KW - Sterilization

KW - Transcervical permanent contraception

KW - Tubal occlusion verification

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