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

Trial Summary

Will I have to stop taking my current medications?

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

Is menstrual cup removal for IUD complications safe?

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 menstrual cup to remove an IUD. More research is needed to understand the safety of this specific procedure. ^{1 2 3 4 5}

How does menstrual cup removal differ from other treatments for IUD complications?

Menstrual cup removal is unique because it addresses the potential risk of IUD expulsion associated with the simultaneous use of menstrual cups, which is not a concern with other menstrual products like tampons or pads. This treatment focuses on preventing complications by managing the interaction between menstrual cups and IUDs, which is a novel approach compared to standard IUD management practices. ^{1 2 3 6 7}

What is the purpose of this trial?

This study will provide pilot data examining suction as a mechanism of IUD displacement with menstrual cup use. The investigator hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. The investigator will also use this data to explore variables associated with IUD displacement and menstrual cup use. By examining the role of suction as a possible mechanism of IUD displacement, this research will allow healthcare providers to better counsel patients who use IUDs regarding menstrual cup use. Having a better understanding of the mechanics of IUD displacement could lead to the development of strategies to prevent expulsion.

Research Team

Cara Clure, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Menstrual cup and risk of IUD expulsion - a systematic review. [2023]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Unintentional IUD expulsion with concomitant menstrual cup use: a case series. [2020]

4. United States 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Intrauterine devices. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Does using tampons or menstrual cups increase early IUD expulsion rates? [2013]

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Extraction of Intrauterine Devices With Nonvisible Threads: 254 Consecutive Cases: An Effective, Noninvasive Technique. [2020]