Menstrual Cup Removal for IUD Complications

Overseen By Eva Dindinger, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Silicone allergy, Vaginal infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how menstrual cups might affect the position of an intrauterine device (IUD), a form of birth control. Researchers seek to determine if the suction created during menstrual cup removal could cause the IUD to shift or become expelled. The findings will help healthcare providers offer better advice to those using both IUDs and menstrual cups. The trial seeks women aged 18-45 who currently have an IUD and are visiting a clinic for IUD removal. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve guidance for IUD and menstrual cup users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for IUD users?

Research has shown that using a menstrual cup while having an IUD (a small device placed in the uterus to prevent pregnancy) might increase the chance of the IUD coming out. Discussing this risk is important for anyone considering participation in a study on this topic.

Some reports also indicate that using a menstrual cup can sometimes cause severe pain or injuries in the vaginal area. A few individuals have experienced allergic reactions, skin rashes, or problems with their bladder or kidneys.

These findings suggest that while menstrual cups are generally safe for many, they can cause issues for some. Anyone interested in the study should be aware of these possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using menstrual cup removal to address IUD complications because it offers a non-invasive alternative to traditional methods like surgical removal or manual extraction. Unlike standard procedures, which can be more invasive and require a clinical setting, this approach utilizes suction to gently remove the cup, potentially reducing discomfort and the risk of further complications. This trial could lead to a simpler, more patient-friendly option for those experiencing issues with their IUDs.

What evidence suggests that menstrual cup removal is effective for IUD complications?

Research has shown that using a menstrual cup might increase the chance of an IUD (intrauterine device) moving out of place. A review of studies found a possible link between menstrual cup use and higher rates of IUD expulsion. One study found that certain IUDs were more likely to be expelled in menstrual cup users over three years. Another study reported that 2.3% of IUDs were expelled after one year, and 4.8% after five years, in users of a specific type of IUD. These findings suggest that menstrual cup use can affect IUD stability. This trial will investigate the removal of menstrual cups as a potential intervention for addressing IUD complications. ^{3 6 7 8 9}

Who Is on the Research Team?

Cara Clure, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who currently have an FDA-approved IUD and are visiting CWHC for IUD removal. They cannot participate if they have a vaginal infection, can't see their IUD strings, are pregnant, or allergic to silicone.

Inclusion Criteria

I am female.

Present to CWHC for IUD removal

Currently has an FDA approved IUD

Exclusion Criteria

IUD strings not visible

I do not have an active vaginal infection.

Positive pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo pelvic exam and transvaginal ultrasound, followed by menstrual cup placement and removal to assess IUD displacement

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for IUD displacement and any adverse effects after menstrual cup use

12-18 months

What Are the Treatments Tested in This Trial?

Interventions

• Suction

Trial Overview The study is testing whether removing menstrual cups in the way manufacturers recommend (by breaking the seal) affects the position of an intrauterine device (IUD). The goal is to understand if suction contributes to IUD displacement.

How Is the Trial Designed?

Group I: Mentrual Cup Removal Experimental Treatment 1 Intervention

Menstrual Cup Removal.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A novel ultrasound-guided technique using laparoscopic forceps was developed to safely and effectively remove intrauterine devices (IUDs) in 254 nonpregnant patients who had previously experienced failed removal attempts.

This approach addresses the common issue of 'lost threads' during speculum examinations, improving the success rate of IUD extractions and enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Extraction of Intrauterine Devices With Nonvisible Threads: 254 Consecutive Cases: An Effective, Noninvasive Technique. Kottmann, C., Troncoso, M., Valenzuela, I., et al.[2020]

In a study of 2,625 women, those who reported intermenstrual bleeding were nearly three times more likely to have their IUD removed due to bleeding or pain, highlighting the importance of monitoring menstrual symptoms after IUD insertion.

Women experiencing excessive menstrual flow were 3.5 times more likely to remove their IUD within a year, suggesting that addressing these issues with counseling and NSAIDs could improve user retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can intrauterine device removals for bleeding or pain be predicted at a one-month follow-up visit? A multivariate analysis. Stanback, J., Grimes, D.[2019]

The systematic review of seven studies found a possible association between menstrual cup use and an increased risk of IUD expulsion, with reported expulsion rates ranging from 3.7% to 18.6%.

Despite the potential risk, the evidence is limited and inconsistent, highlighting the need for more high-quality randomized controlled trials to better understand the relationship between menstrual cup use and IUD expulsion, especially for younger women who are increasingly using both products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual cup and risk of IUD expulsion - a systematic review. Bowman, N., Thwaites, A.[2023]

The intrauterine device (IUD) is an effective contraceptive method used by approximately 60 million women globally, but its popularity in the U.S. is limited due to nonmedical reasons; its mechanism of action may involve spermicidal activity.

While there is a low risk of pelvic infection associated with IUD use, prophylactic antibiotics during insertion can further reduce this risk, and users do not have increased risks for cervical infections or significant complications from a retroflexed uterine position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrauterine devices. Burkman, RT.[2019]

There have been seven reported cases of intrauterine device (IUD) expulsion occurring while using a menstrual cup, raising concerns about the safety of using both contraceptive methods together.

Further research is necessary to understand the mechanisms behind IUD expulsion during menstrual cup use and to identify predictors and strategies to prevent such expulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional IUD expulsion with concomitant menstrual cup use: a case series. Seale, R., Powers, L., Guiahi, M., et al.[2020]

In a study of 930 women using IUDs, only 2.5% experienced full or partial expulsion of the device within the first 6 weeks after insertion, indicating a generally low expulsion rate.

There was no significant difference in expulsion rates among women using menstrual cups, tampons, or pads, suggesting that using these menstrual products does not increase the risk of IUD expulsion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does using tampons or menstrual cups increase early IUD expulsion rates? Wiebe, ER., Trouton, KJ.[2013]

In a survey of 902 women, 19.7% reported using menstrual cups, and among IUD users, 8.8% experienced IUD expulsion, indicating a notable prevalence of both IUD use and menstrual cup use.

The study found a significant association between menstrual cup use and IUD expulsion, with an odds ratio of 2.75, suggesting that using a menstrual cup may increase the risk of IUD expulsion compared to using tampons or pads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do menstrual cups increase risk of IUD expulsion? A survey of self-reported IUD and menstrual hygiene product use in the United States. Schnyer, AN., Jensen, JT., Edelman, A., et al.[2020]

Citations

1. contraceptionmedicine.biomedcentral.com contraceptionmedicine.biomedcentral.com/articles/10.1186/s40834-022-00203-x

Menstrual cup and risk of IUD expulsion – a systematic review There is a possible association between menstrual cup use and increased risk of IUD expulsion and this information should be shared with patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11081833/

Menstrual Cup Use and Intrauterine Device Expulsion in a ... A large retrospective cohort study found one- and five-year cumulative copper 380 mm2 IUD expulsion rates of 2.3% and 4.8%, respectively [3].

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782424000684

Menstrual cup use and intrauterine device expulsion in a ... We found higher odds of IUD expulsion with menstrual cup and concurrent NTCu380-Mini IUD use over 36 months of use, but not with concurrent TCu380A IUD use.

4. researchstudies.cuanschutz.edu researchstudies.cuanschutz.edu/Study/21-4267

Pilot Study of suction as a mechanism of IUD Expulsion ... We hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. We ...

5. journals.lww.com journals.lww.com/greenjournal/abstract/2020/05001/menstrual_cup_use_and_intrauterine_device.3.aspx

Menstrual Cup Use and Intrauterine Device Expulsion in a... CONCLUSION: We found higher than expected IUD expulsion rates in menstrual cup users amongst participants in a prospective trial of two copper IUDs. Copper IUD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9863186/

Menstrual cup and risk of IUD expulsion – a systematic ... There is a possible association between menstrual cup use and increased risk of IUD expulsion and this information should be shared with patients.

7. withpower.com withpower.com/trial/menstrual-cup-removal-for-iud-complications-58d3f

Menstrual Cup Removal for IUD Complications Using a menstrual cup while having an IUD may increase the risk of the IUD being expelled (coming out), but there is no specific safety data on using a ...

8. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(24)00068-4/abstract

Menstrual cup use and intrauterine device expulsion in a ... Implications. Menstrual cup and NTCu380-Mini use may increase IUD expulsion risk and may increase accidental self-removal risk with TCu380A and NTCu380-Mini use ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669309/

Menstrual cup use, leakage, acceptability, safety, and ... We identified five women who reported severe pain or vaginal wounds, six reports of allergies or rashes, nine of urinary tract complaints (three ...