Menstrual CupNCT07137663
The Use of Menstrual Cups in the Menstrual Health and Hygiene Management of Women Who Use Wheelchairs
A study testing Educational and practical intervention on menstrual cup use in people with Menstrual Cup and Menstrual Hygiene Management, run by Hülya ULAŞLI KABAN.
Trial summary
This study is designed to evaluate the impact of menstrual cup use on menstrual health and hygiene management among women who use wheelchairs.In addition, the study will serve as a reference for future research that includes other groups of people with disabilities and will contribute to the literature. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Menstrual Cup, Menstrual Hygiene Management, Disabled People
- What is being tested?
- Educational and practical intervention on menstrual cup use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 2 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having previously used a method other than a menstrual cup during menstruation,
- Being between 18 and 45 years of age,
- Having a regular menstrual cycle between 21-35 days,
- Not having a diagnosed and treated sexually transmitted infection,
- Not having a silicone allergy,
- Not having a known vaginal anatomical defect,
- Being able to actively use both arms and hands.
Who cannot join
- Planning to become pregnant,
- Having had a urogenital tract infection in the past 3 months (based on self-report),
- Having known conditions such as fibroids, endometritis, gynecological disorders, renal colic, or hydronephrosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Use of Menstrual Cups in the Menstrual Health and Hygiene Management of Women Using Wheelchairs
This study is designed to evaluate the impact of menstrual cup use on menstrual health and hygiene management among women who use wheelchairs.In addition, the study will serve as a reference for future research that includes other groups of people with disabilities and will contribute to the literature. The main questions it aims to answer are:
How does menstrual cup use affect the menstrual hygiene management experiences of women who use wheelchairs?
Read more
What impact does menstrual cup use have on women's comfort, perception of hygiene, and participation in social life?
Do women's knowledge, attitudes, and satisfaction levels regarding menstrual cup use change over time?
Why do women who use wheelchairs choose to use or not to use menstrual cups? This quasi-experimental study will use a repeated measures design (within-subjects design). Participants included in the study will be scheduled for an appointment to receive training on menstrual cup use and to be provided with a menstrual cup. The training will be conducted face-to-face in the education room of the relevant association. During this session, the participant will first respond to the initial part of the questionnaire. Following that, she will receive training on menstrual cup use (supported by video, models, etc.), and based on the information obtained, a menstrual cup in a suitable size will be provided. The menstrual cups to be used by the participants will be supplied by the researcher.
After the initial meeting, six follow-up interviews will be conducted following the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual periods. In each session, participants will be asked to complete a follow-up-specific questionnaire, and any questions they have will be answered. Their use of the menstrual cup will be assessed during each follow-up. If a participant is not using the cup, the reasons for non-use will be explored, and if desired, the training will be repeated or individual counseling will be provided. If the participant refuses counseling or states that she no longer wishes to use the cup, she will be withdrawn from the study. If a participant drops out during the first three follow-ups, a new participant will be recruited to replace her.
- Conditions
- Menstrual Cup, Menstrual Hygiene Management, Disabled People
- Being tested
- Educational and practical intervention on menstrual cup use
- Keywords
- Menstrual Cup, Menstrual Hygiene Management, Persons with Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and practical intervention on menstrual cup useOther
The intervention implemented in this study is a unique approach tailored to menstrual hygiene management among women who use wheelchairs. What distinguishes this intervention from others is the combination of both education and practical support for menstrual cup use. While menstrual hygiene management in the literature generally targets the general population, this study specifically addresses the unique needs and challenges faced by women with disabilities by providing individualized menstrual cup selection and usage guidance. Additionally, the intervention includes repeated follow-ups over six menstrual cycles, allowing continuous support and monitoring of the participants' experiences. This approach aims not only to improve hygiene practices but also to enhance user satisfaction and long-term adherence. The comprehensive and personalized nature of this intervention differentiates it from most existing studies and seeks to offer practical, sustainable solutions for menstrual hygiene
| Study group | Role | What they receive |
|---|---|---|
| Study group (Mentrual Cup Group) | Experimental | This is a single-arm study. All participants will receive a structured educational session on menstrual cup use, including hygiene, insertion and removal techniques, maintenance, and troubleshooting. Following the training, each participant will be provided with one menstrual cup for personal use. Participants will be instructed to use the cup over the course of six consecutive menstrual cycles. User satisfaction and experiences with the menstrual cup will be monitored and assessed through follow-up questionnaires at regular intervals throughout the study period. There is no control or comparator arm in this study.The study, which was semi-experimental in nature, used a repeated measures design (within-subjects design). In this type of experimental design, the participants included in the study participate in all experimental conditions. Therefore, the participants form their own control group, which increases the sensitivity of the experiment. The difference between the measurements Receives: Other: Educational and practical intervention on menstrual cup use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Satisfaction and Acceptability Levels in First-Time Menstrual Cup Users Who Use Wheelchairs after 6-Month Menstrual Periods Follow-Up
The study used a structured data collection form developed by the researcher based on the literature and expert opinions. The initial section (23 items) assessed participants' sociodemographic characteristics, parity, and menstrual hygiene management. Follow-up forms after menstrual periods 1-5 (18 items) evaluated menstrual cup use and menstrual hygiene management, while the final follow-up after the 6th menstrual period (23 items) included additional questions on satisfaction with menstrual cup use and perceived changes in menstrual hygiene management.
Satisfaction with menstrual cup use was assessed using a Likert scale regarding insertion, removal, cleaning, leakage prevention, storage, odor control, comfort during daily activities, comfort during sleep, overall comfort, and perceived advantages over other menstrual hygiene products (1 = very poor, 5 = very good). Ease of use for insertion, removal, cleaning, and storage was rated as 1 = easy, 2 = not very easy, 3 = difficult.
Measured: Baseline and 6 months.
Secondary outcomes (1)
Composite questionnaires in Change from baseline in menstrual hygiene management (social life, economic aspects, and overall comfort) compared to the previous menstrual hygiene product at the 6th menstrual period.
The study used a structured data collection form developed by the researcher based on the literature and expert opinions. The initial section (23 items) assessed participants' sociodemographic characteristics, parity, and menstrual hygiene management. Follow-up forms after menstrual periods 1-5 (18 items) evaluated menstrual cup use and menstrual hygiene management, while the final follow-up after the 6th menstrual period (23 items) included additional questions on satisfaction with menstrual cup use and perceived changes in menstrual hygiene management.The menstrual periods during which participants used menstrual cups will be compared with the periods during which they used other sanitary products; perceived changes (positive/negative/no change) in economic and social life and sleep will be measured in the final follow-up form.
Measured: Baseline and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion2 Nov 2025 (estimated)
- Study completion2 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Menstrual CupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hülya ULAŞLI KABAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hülya ULAŞLI KABAN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137663
- Sponsor's protocol ID
- 2025/343
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilbur J, Torondel B, Hameed S, Mahon T, Kuper H. Systematic review of menstrual hygiene management requirements, its barriers and strategies for disabled people. PLoS One. 2019 Feb 6;14(2):e0210974. doi: 10.1371/journal.pone.0210974. eCollection 2019.
PubMed 30726254Weerawatsopon, S., Luangdansakul, W., Prommas, S., Smanchat, B., Bhamarapravatana, K., Suwannarurk, K., 2021, Comparative study of satisfaction and acceptability between using menstrual cup versus sanitary pads in health care personnel: A randomized crossover trial, Journal of the Medical Association of Thailand, 104 (1).
van Eijk AM, Zulaika G, Lenchner M, Mason L, Sivakami M, Nyothach E, Unger H, Laserson K, Phillips-Howard PA. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health. 2019 Aug;4(8):e376-e393. doi: 10.1016/S2468-2667(19)30111-2. Epub 2019 Jul 16.
PubMed 31324419Singh R, Agarwal M, Sinha S, Chaudhary N, Sinha HH, Anant M. Study of Adaptability and Efficacy of Menstrual Cups in Managing Menstrual Health and Hygiene: A Descriptive Longitudinal Study. Cureus. 2022 Sep 28;14(9):e29690. doi: 10.7759/cureus.29690. eCollection 2022 Sep.
PubMed 36187174Shihata, A. A., Brody, S., 2019, Five year study of a unique, eco-friendly, menstrual cup, that enhances the quality of women's lives during menstruation, Journal of Gynecology and Obstetrics, 7, 161-165.
Rinku, N.J., 2022, Experience of female wheelchair users' personal hygiene management during menstruation. Doctoral Thesis. Bangladesh Health Professions Institute, Faculty of Medicine, the University of Dhaka, Banglades
Hennegan J, Orozco A, Head A, Marino JL, Jayasinghe Y, Lim MSC. Menstrual cup acceptability and functionality in real-world use: A cross-sectional survey of young people in Australia. Aust N Z J Obstet Gynaecol. 2025 Jun;65(3):382-389. doi: 10.1111/ajo.13910. Epub 2024 Dec 13.
PubMed 39670424Dündar, T., Özsoy, S., 2025, The use of menstrual cups among visually impaired women, British Journal of Visual Impairment, 43 (2), 423-436.
Dündar, T., Özsoy, S., 2020, Menstrual hijyen yönetiminde menstrual kap kullanımı, Kadın Sağlığı Hemşireliği Dergisi, 6 (1), 14-28.
Gharacheh M, Ranjbar F, Hajinasab N, Haghani S. Acceptability and safety of the menstrual cups among Iranian women: a cross-sectional study. BMC Womens Health. 2021 Mar 13;21(1):105. doi: 10.1186/s12905-021-01259-8.
PubMed 33714263Beksinska M, Nkosi P, Zulu B, Smit J. Acceptability of the menstrual cup among students in further education institutions in KwaZulu-Natal, South Africa. Eur J Contracept Reprod Health Care. 2021 Feb;26(1):11-16. doi: 10.1080/13625187.2020.1815005. Epub 2020 Sep 17.
PubMed 32938248Averbach S, Sahin-Hodoglugil N, Musara P, Chipato T, van der Straten A. Duet for menstrual protection: a feasibility study in Zimbabwe. Contraception. 2009 Jun;79(6):463-8. doi: 10.1016/j.contraception.2008.12.002.
PubMed 19442783
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Use of Menstrual Cups in the Menstrual Health and Hygiene Management of Women Using Wheelchairs
- ClinicalTrials.gov ID
- NCT07137663
- Acronym / sponsor ID
- 2025/343
- Conditions
- Menstrual Cup, Menstrual Hygiene Management, Disabled People
- Keywords
- Menstrual Cup, Menstrual Hygiene Management, Persons with Disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hülya ULAŞLI KABANUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 2 Nov 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the impact of menstrual cup use on menstrual health and hygiene management among women who use wheelchairs.In addition, the study will serve as a reference for future research that includes other groups of people with disabilities and will contribute to the literature. The main questions it aims to answer are:
How does menstrual cup use affect the menstrual hygiene management experiences of women who use wheelchairs?
What impact does menstrual cup use have on women's comfort, perception of hygiene, and participation in social life?
Do women's knowledge, attitudes, and satisfaction levels regarding menstrual cup use change over time?
Why do women who use wheelchairs choose to use or not to use menstrual cups? This quasi-experimental study will use a repeated measures design (within-subjects design). Participants included in the study will be scheduled for an appointment to receive training on menstrual cup use and to be provided with a menstrual cup. The training will be conducted face-to-face in the education room of the relevant association. During this session, the participant will first respond to the initial part of the questionnaire. Following that, she will receive training on menstrual cup use (supported by video, models, etc.), and based on the information obtained, a menstrual cup in a suitable size will be provided. The menstrual cups to be used by the participants will be supplied by the researcher.
After the initial meeting, six follow-up interviews will be conducted following the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual periods. In each session, participants will be asked to complete a follow-up-specific questionnaire, and any questions they have will be answered. Their use of the menstrual cup will be assessed during each follow-up. If a participant is not using the cup, the reasons for non-use will be explored, and if desired, the training will be repeated or individual counseling will be provided. If the participant refuses counseling or states that she no longer wishes to use the cup, she will be withdrawn from the study. If a participant drops out during the first three follow-ups, a new participant will be recruited to replace her.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group (Mentrual Cup Group) | Experimental | Other: Educational and practical intervention on menstrual cup useThis is a single-arm study. All participants will receive a structured educational session on menstrual cup use, including hygiene, insertion and removal techniques, maintenance, and troubleshooting. Following the training, each participant will be provided with one menstrual cup for personal use. Participants will be instructed to use the cup over the course of six consecutive menstrual cycles. User satisfaction and experiences with the menstrual cup will be monitored and assessed through follow-up questionnaires at regular intervals throughout the study period. There is no control or comparator arm in this study.The study, which was semi-experimental in nature, used a repeated measures design (within-subjects design). In this type of experimental design, the participants included in the study participate in all experimental conditions. Therefore, the participants form their own control group, which increases the sensitivity of the experiment. The difference between the measurements |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Having previously used a method other than a menstrual cup during menstruation,
- Being between 18 and 45 years of age,
- Having a regular menstrual cycle between 21-35 days,
- Not having a diagnosed and treated sexually transmitted infection,
- Not having a silicone allergy,
Key exclusion criteria (3 listed)
- Planning to become pregnant,
- Having had a urogenital tract infection in the past 3 months (based on self-report),
- Having known conditions such as fibroids, endometritis, gynecological disorders, renal colic, or hydronephrosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational and practical intervention on menstrual cup useThe intervention implemented in this study is a unique approach tailored to menstrual hygiene management among women who use wheelchairs. What distinguishes this intervention from others is the combination of both education and practical support for menstrual cup use. While menstrual hygiene management in the literature generally targets the general population, this study specifically addresses the unique needs and challenges faced by women with disabilities by providing individualized menstrual cup selection and usage guidance. Additionally, the intervention includes repeated follow-ups over six menstrual cycles, allowing continuous support and monitoring of the participants' experiences. This approach aims not only to improve hygiene practices but also to enhance user satisfaction and long-term adherence. The comprehensive and personalized nature of this intervention differentiates it from most existing studies and seeks to offer practical, sustainable solutions for menstrual hygiene | Other | Study group (Mentrual Cup Group) |
Primary outcome
Change from Baseline in Satisfaction and Acceptability Levels in First-Time Menstrual Cup Users Who Use Wheelchairs after 6-Month Menstrual Periods Follow-Up
Time frame: Baseline and 6 months.
The study used a structured data collection form developed by the researcher based on the literature and expert opinions. The initial section (23 items) assessed participants' sociodemographic characteristics, parity, and menstrual hygiene management. Follow-up forms after menstrual periods 1-5 (18 items) evaluated menstrual cup use and menstrual hygiene management, while the final follow-up after the 6th menstrual period (23 items) included additional questions on satisfaction with menstrual cup use and perceived changes in menstrual hygiene management. Satisfaction with menstrual cup use was assessed using a Likert scale regarding insertion, removal, cleaning, leakage prevention, storage, odor control, comfort during daily activities, comfort during sleep, overall comfort, and perceived advantages over other menstrual hygiene products (1 = very poor, 5 = very good). Ease of use for insertion, removal, cleaning, and storage was rated as 1 = easy, 2 = not very easy, 3 = difficult.
1 secondary outcome
Composite questionnaires in Change from baseline in menstrual hygiene management (social life, economic aspects, and overall comfort) compared to the previous menstrual hygiene product at the 6th menstrual period.
Time frame: Baseline and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 30726254Wilbur J, Torondel B, Hameed S, Mahon T, Kuper H. Systematic review of menstrual hygiene management requirements, its barriers and strategies for disabled people. PLoS One. 2019 Feb 6;14(2):e0210974. doi: 10.1371/journal.pone.0210974. eCollection 2019.
- BackgroundWeerawatsopon, S., Luangdansakul, W., Prommas, S., Smanchat, B., Bhamarapravatana, K., Suwannarurk, K., 2021, Comparative study of satisfaction and acceptability between using menstrual cup versus sanitary pads in health care personnel: A randomized crossover trial, Journal of the Medical Association of Thailand, 104 (1).
- Background: PubMed 31324419van Eijk AM, Zulaika G, Lenchner M, Mason L, Sivakami M, Nyothach E, Unger H, Laserson K, Phillips-Howard PA. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health. 2019 Aug;4(8):e376-e393. doi: 10.1016/S2468-2667(19)30111-2. Epub 2019 Jul 16.
- Background: PubMed 36187174Singh R, Agarwal M, Sinha S, Chaudhary N, Sinha HH, Anant M. Study of Adaptability and Efficacy of Menstrual Cups in Managing Menstrual Health and Hygiene: A Descriptive Longitudinal Study. Cureus. 2022 Sep 28;14(9):e29690. doi: 10.7759/cureus.29690. eCollection 2022 Sep.
- BackgroundShihata, A. A., Brody, S., 2019, Five year study of a unique, eco-friendly, menstrual cup, that enhances the quality of women's lives during menstruation, Journal of Gynecology and Obstetrics, 7, 161-165.
- BackgroundRinku, N.J., 2022, Experience of female wheelchair users' personal hygiene management during menstruation. Doctoral Thesis. Bangladesh Health Professions Institute, Faculty of Medicine, the University of Dhaka, Banglades
- Background: PubMed 39670424Hennegan J, Orozco A, Head A, Marino JL, Jayasinghe Y, Lim MSC. Menstrual cup acceptability and functionality in real-world use: A cross-sectional survey of young people in Australia. Aust N Z J Obstet Gynaecol. 2025 Jun;65(3):382-389. doi: 10.1111/ajo.13910. Epub 2024 Dec 13.
- BackgroundDündar, T., Özsoy, S., 2025, The use of menstrual cups among visually impaired women, British Journal of Visual Impairment, 43 (2), 423-436.
- BackgroundDündar, T., Özsoy, S., 2020, Menstrual hijyen yönetiminde menstrual kap kullanımı, Kadın Sağlığı Hemşireliği Dergisi, 6 (1), 14-28.
- Background: PubMed 33714263Gharacheh M, Ranjbar F, Hajinasab N, Haghani S. Acceptability and safety of the menstrual cups among Iranian women: a cross-sectional study. BMC Womens Health. 2021 Mar 13;21(1):105. doi: 10.1186/s12905-021-01259-8.
- Background: PubMed 32938248Beksinska M, Nkosi P, Zulu B, Smit J. Acceptability of the menstrual cup among students in further education institutions in KwaZulu-Natal, South Africa. Eur J Contracept Reprod Health Care. 2021 Feb;26(1):11-16. doi: 10.1080/13625187.2020.1815005. Epub 2020 Sep 17.
- Background: PubMed 19442783Averbach S, Sahin-Hodoglugil N, Musara P, Chipato T, van der Straten A. Duet for menstrual protection: a feasibility study in Zimbabwe. Contraception. 2009 Jun;79(6):463-8. doi: 10.1016/j.contraception.2008.12.002.
- Menstrual Hygiene ManagementLink provided by the sponsor.
- World report on disability 2011Link provided by the sponsor.
- Global report on health equity for persons with disabilitiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and practical intervention on menstrual cup use in people with Menstrual Cup and Menstrual Hygiene Management, run by Hülya ULAŞLI KABAN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hülya ULAŞLI KABAN (+90 5530935775, hulya_ulasli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Satisfaction and Acceptability Levels in First-Time Menstrual Cup Users Who Use Wheelchairs after 6-Month Menstrual Periods Follow-Up (time frame: Baseline and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07137663, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.