Abnormal Uterine Bleeding, Intrauterine Device (IUD)
Conditions
Brief summary
To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
Interventions
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • Age 18 years or older * Speaks and reads in English * Able to consent on their own * Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group) * Cervix at least 26 mm in diameter * Twenty providers performing this procedure
Exclusion criteria
* • Vaginal bleeding of unknown origin * Cervix less than 26 mm in diameter * Nabothian cyst on anterior lip of cervix * Cervical myomas * Cervical abnormalities * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-perceived Pain | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) | Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. Participants fill out their survey once the procedure and clinical appointment is concluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider-perceived Bleeding | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) | Bleeding perceived by the provider during and after the procedure. |
| Provider-perceived Ease of Use | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) | Providers will report their perceived ease of use with the Carevix device indicating Strongly Disagree, Disagree, Agree, or Strongly Agree and open response. |
| Provider-perceived Satisfaction | Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion) | Providers will report their perceived satisfaction indicating Strongly Disagree, Disagree, Agree, or Strongly Agree and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from a women's health clinic in Indianapolis. Enrolled participants were at least 18 years old, English-speaking, and scheduled to undergo an intrauterine procedure. A total of 73 patients were enrolled with 60 eligible participants who received cervical stabilization during their procedure.
Pre-assignment details
Patients were ineligible if they did not meet these criteria, as well as if they presented with vaginal bleeding of unknown origin, cervix less than 26 mm in diameter, Nabothian cyst on anterior lip of cervix, cervical myomas, cervical abnormalities/shape, or if they were pregnant. Patients were also designated ineligible if they did not receive any cervical stabilization. Patients were recruited in two waves corresponding with each arm.
Participants by arm
| Arm | Count |
|---|---|
| Carevix Suction cervical stabilizer utilized for intrauterine procedures
Carevix: Cervical stabilization device that uses vacuum | 30 |
| Tenaculum Standard of care cervical stabilization device
Tenaculum: standard of care cervical stabilization device | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Carevix | Tenaculum | Total |
|---|---|---|---|
| Age, Customized Age (years) 18-19 | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized Age (years) 20-30 | 14 Participants | 6 Participants | 20 Participants |
| Age, Customized Age (years) 31-40 | 8 Participants | 11 Participants | 19 Participants |
| Age, Customized Age (years) 41-50 | 6 Participants | 8 Participants | 14 Participants |
| Age, Customized Age (years) 51-60 | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized Age (years) 61+ | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Age (years) Missing | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Full-time (40+ hours a week) | 16 Participants | 19 Participants | 35 Participants |
| Employment Status Missing | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Other | 0 Participants | 0 Participants | 0 Participants |
| Employment Status Part-time (less than 40 hours a week) | 3 Participants | 1 Participants | 4 Participants |
| Employment Status Prefer not to say | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Retired | 1 Participants | 1 Participants | 2 Participants |
| Employment Status Self-employed, Freelance, or Contractor | 2 Participants | 3 Participants | 5 Participants |
| Employment Status Student | 3 Participants | 1 Participants | 4 Participants |
| Employment Status Student and Full-time | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Student and Part-time | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Unemployed | 3 Participants | 3 Participants | 6 Participants |
| Highest level of complete education Associate, Technical, or 2 year degree | 3 Participants | 3 Participants | 6 Participants |
| Highest level of complete education Bachelor's or 4 year degree | 10 Participants | 9 Participants | 19 Participants |
| Highest level of complete education Doctorate | 1 Participants | 2 Participants | 3 Participants |
| Highest level of complete education High School, GE, or equivalent | 11 Participants | 5 Participants | 16 Participants |
| Highest level of complete education Less than High School | 0 Participants | 1 Participants | 1 Participants |
| Highest level of complete education License or Professional Certification | 0 Participants | 0 Participants | 0 Participants |
| Highest level of complete education Master's degree | 3 Participants | 5 Participants | 8 Participants |
| Highest level of complete education Other | 2 Participants | 0 Participants | 2 Participants |
| Highest level of complete education Prefer not to say | 0 Participants | 0 Participants | 0 Participants |
| Highest level of complete education Some college | 0 Participants | 5 Participants | 5 Participants |
| Marital Status Divorced | 1 Participants | 2 Participants | 3 Participants |
| Marital Status Domestic partnership (or living together but not married) | 5 Participants | 2 Participants | 7 Participants |
| Marital Status Married | 10 Participants | 13 Participants | 23 Participants |
| Marital Status Other | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Prefer not to say | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Single | 13 Participants | 13 Participants | 26 Participants |
| Marital Status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Nulliparous/Multiparous Caesarean Section delivery | 4 Participants | 3 Participants | 7 Participants |
| Nulliparous/Multiparous Multiparous | 18 Participants | 17 Participants | 35 Participants |
| Nulliparous/Multiparous Nulliparous | 12 Participants | 13 Participants | 25 Participants |
| Nulliparous/Multiparous Vaginal delivery | 14 Participants | 16 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 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 / 36 | 0 / 37 |
| other Total, other adverse events | 0 / 36 | 0 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 |
Outcome results
Primary
Patient-perceived Pain
Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. Participants fill out their survey once the procedure and clinical appointment is concluded.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Population: Participants who underwent an intrauterine procedure with either the Carevix device or the Tenaculum.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carevix | Patient-perceived Pain | 3 score on a scale |
| Tenaculum | Patient-perceived Pain | 4 score on a scale |
p-value: 0.21Wilcoxon (Mann-Whitney)
Secondary
Provider-perceived Bleeding
Bleeding perceived by the provider during and after the procedure.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Population: Providers who completed the intrauterine procedure with their respective participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carevix | Provider-perceived Bleeding | Had to manage/stop bleeding on cervical tissues | 3 Participants |
| Carevix | Provider-perceived Bleeding | Did not have to manage/stop bleeding | 27 Participants |
| Tenaculum | Provider-perceived Bleeding | Had to manage/stop bleeding on cervical tissues | 9 Participants |
| Tenaculum | Provider-perceived Bleeding | Did not have to manage/stop bleeding | 21 Participants |
p-value: 0.1Fisher Exact
Secondary
Provider-perceived Ease of Use
Providers will report their perceived ease of use with the Carevix device indicating Strongly Disagree, Disagree, Agree, or Strongly Agree and open response.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Population: Providers were only asked about the Ease of use for the Carevix device.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carevix | Provider-perceived Ease of Use | Strongly Agree | 12 Participants |
| Carevix | Provider-perceived Ease of Use | Agree | 17 Participants |
| Carevix | Provider-perceived Ease of Use | Disagree | 1 Participants |
| Carevix | Provider-perceived Ease of Use | Strongly Disagree | 0 Participants |
| Carevix | Provider-perceived Ease of Use | I don't know/Not sure | 0 Participants |
Secondary
Provider-perceived Satisfaction
Providers will report their perceived satisfaction indicating Strongly Disagree, Disagree, Agree, or Strongly Agree and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.
Time frame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Population: Providers who completed the intrauterine procedure with their respective participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carevix | Provider-perceived Satisfaction | Agree | 10 Participants |
| Carevix | Provider-perceived Satisfaction | Disagree | 5 Participants |
| Carevix | Provider-perceived Satisfaction | I don't know not sure | 0 Participants |
| Carevix | Provider-perceived Satisfaction | Strongly Disagree | 1 Participants |
| Carevix | Provider-perceived Satisfaction | Strongly Agree | 14 Participants |
| Tenaculum | Provider-perceived Satisfaction | Strongly Disagree | 1 Participants |
| Tenaculum | Provider-perceived Satisfaction | Strongly Agree | 2 Participants |
| Tenaculum | Provider-perceived Satisfaction | Agree | 8 Participants |
| Tenaculum | Provider-perceived Satisfaction | I don't know not sure | 16 Participants |
| Tenaculum | Provider-perceived Satisfaction | Disagree | 3 Participants |
p-value: 0.001Fisher Exact