Contraception
Conditions
Keywords
HSG, HyCoSy, Contraception, Essure, Saline Infused sonography, SIS, Air bubbles
Brief summary
The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.
Detailed description
The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency. This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test. Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.
Interventions
DEVICEHyCoSy
Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes
Sponsors
Bayer
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor does not know which procedure was received first or second.
Intervention model description
Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documentation of normal Pap smear within 1 year prior to enrollment into study. * Written informed consent given * Need for evaluation of tubal status for post-Essure tubal occlusion * Negative urine pregnancy test
Exclusion criteria
* History of unresolved dysfunctional uterine bleeding (DUB). * History of a hysterectomy. * Current urogenital disease. * History of allergic response to IVP dye (exclusion for HSG). * Abnormal pap smear. * Positive urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fallopian Tube Patency - HyCoSy vs HSG | At time of procedure | Observed flow of fluid/bubbles through fallopian tubes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | At time of procedures | Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces) |
| Physician Evaluation of Uterine Cavity | At time of HyCoSy procedure | Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as normal' or not normal. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from existing practice and clinic patients who had the Essure device placed for contraception.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (HyCoSy Followed by HSG) HyCoSy procedure followed by HSG procedure
HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes | 13 |
| Arm 1 (HyCoSy Followed by HSG) HyCoSy procedure followed by HSG procedure
HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes | 26 |
| Arm 2 (HSG Followed by HyCoSy) HSG procedure followed by HyCoSy procedure
HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes | 6 |
| Arm 2 (HSG Followed by HyCoSy) HSG procedure followed by HyCoSy procedure
HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes | 12 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Break (1 Hour) | Withdrawal by Subject | 0 | 1 |
| Second Test (1 Hour) | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 2 (HSG Followed by HyCoSy) | Total | Arm 1 (HyCoSy Followed by HSG) |
|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 6.7 | 37.3 years STANDARD_DEVIATION 6.5 | 37.9 years STANDARD_DEVIATION 6.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 19 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 19 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 6 |
| other Total, other adverse events | 0 / 13 | 0 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 6 |
Outcome results
Primary
Fallopian Tube Patency - HyCoSy vs HSG
Observed flow of fluid/bubbles through fallopian tubes.
Time frame: At time of procedure
Population: Analysis was per fallopian tube.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Arm 1 (HyCoSy Followed by HSG) | Fallopian Tube Patency - HyCoSy vs HSG | Number of tubes closed per first procedure | 24 fallopian tubes observed to be closed |
| Arm 1 (HyCoSy Followed by HSG) | Fallopian Tube Patency - HyCoSy vs HSG | Number of tubes closed per second procedure | 25 fallopian tubes observed to be closed |
| Arm 2 (HSG Followed by HyCoSy) | Fallopian Tube Patency - HyCoSy vs HSG | Number of tubes closed per first procedure | 12 fallopian tubes observed to be closed |
| Arm 2 (HSG Followed by HyCoSy) | Fallopian Tube Patency - HyCoSy vs HSG | Number of tubes closed per second procedure | 12 fallopian tubes observed to be closed |
p-value: <0.01Kappa
Secondary
Pain Scores
Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)
Time frame: At time of procedures
Population: Change in patient reported pain scores (pre-procedure minus post-procedure pain scores)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 (HyCoSy Followed by HSG) | Pain Scores | HSG post procedure pain score | 1.4 units on a scale | Standard Deviation 2.1 |
| Arm 1 (HyCoSy Followed by HSG) | Pain Scores | HyCoSy post procedure pain score | 2.4 units on a scale | Standard Deviation 3.1 |
| Arm 2 (HSG Followed by HyCoSy) | Pain Scores | HSG post procedure pain score | 1.8 units on a scale | Standard Deviation 4 |
| Arm 2 (HSG Followed by HyCoSy) | Pain Scores | HyCoSy post procedure pain score | 2.3 units on a scale | Standard Deviation 2.6 |
p-value: <0.395% CI: [-2.69, 1]t-test, 2 sided
Secondary
Physician Evaluation of Uterine Cavity
Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as normal' or not normal.
Time frame: At time of HyCoSy procedure
Population: Number of uteri assessed as 'normal'
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 (HyCoSy Followed by HSG) | Physician Evaluation of Uterine Cavity | 13 Participants |
| Arm 2 (HSG Followed by HyCoSy) | Physician Evaluation of Uterine Cavity | 6 Participants |
p-value: <0.6795% CI: [-2.4, 1.56]t-test, 2 sided