Primary DysmenorrheaNCT06803173
Pelvic Floor Muscle Activity in Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD). Read more about this study
- Who is it for?
- Ages 19 to 24 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 15 Apr 2025
- Phase
- Observational
- 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 19 to 24 years
- Women only
- No healthy volunteers
- Adult
Study population: Seventy-eight female physiotherapy students with PD will participate in this study. They will be selected randomly from the faculty of physical therapy at Cairo University.
Who may be able to join
- They should be virgin, healthy female physiotherapy students with PD.
- They have regular menstruation (3-8 days in duration, with 21-35 days in between).
- Their ages will range from 18 to 25 years old.
- Their body mass index (BMI) will range from 18 to 24.9 kg/m2.
- Their waist-to-hip ratio will be less than 0.8.
Who cannot join
- Any urological or gynecological disorders in the previous 12 weeks (e.g., endometriosis, fibroids).
- Fibromyalgia.
- Severe psychiatric or psychological disorders.
- Those who had taken analgesics in the 12 hours before the assessment.
- Abdominal or pelvic surgery within the past six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amira Nagy Abdellatif, PhD contact
Egypt1 site
Cairo University
Giza
Wafaa AM Abdelraouf Mohamed, B.Sc.
Amira Nagy Abdellatif, PhD
About this study
This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).
Read the detailed description
Dysmenorrhea, marked by painful menstrual cramps, often involves increased PFM tension, spasms, and inflammation, affecting females' quality of life and productivity. The traditional focus has been on investigating the abdominal region in women with PD. However, this new perspective considers that the hormonal changes experienced during the menstrual cycle in PD patients may lead to a heightened sensitivity of the PFM, not just the abdominal area. This suggests that the pain associated with PD may have a more widespread impact on the pelvic region rather than being localized to the abdomen. Pelvic floor myofascial trigger points (MTrPs) may also exacerbate menstrual pain through the neural pathway.
There is a critical gap in the literature regarding the nature of the association between dysmenorrhea and PFM activity in this population. Yet, it is unknown whether the pain is a cause or result of increased PFM tone, and the nature of the association between menstrual pain and PFM tone in women with PD is also unknown.
So, this study utilizes transabdominal ultrasound (TAU) to examine PFM activity in PD, aiming to clarify how PFM activity contributes to menstrual pain. Understanding these dynamics could lead to preventive strategies and educational efforts highlighting the role of pelvic floor interventions in managing dysmenorrhea, potentially improving treatment methods and overall women's health management.
- Conditions
- Primary Dysmenorrhea
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| group of mild primary dysmenorrhea | It will consist of 26 females with mild dysmenorrhea (WaLIDD score =1-4) Receives: Other: No intervention | |
| group of moderate primary dysmenorrhea | It will consist of 26 females with moderate dysmenorrhea (WaLIDD score =5-7) Receives: Other: No intervention | |
| group of severe primary dysmenorrhea | It will consist of 26 females with severe dysmenorrhea (WaLIDD score =8-12) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle (PFM) contraction
Transabdominal ultrasound (TAU) will be used to assess PFM contraction for all females ("cutting off the flow of urine mid-stream") in the three groups.
Measured: 1 month
Pelvic floor muscle (PFM) relaxation
Transabdominal ultrasound (TAU) will be used to assess PFM relaxation during inspiration for all females.
Measured: 1 month
Secondary outcomes (3)
Bladder section of the Australian Pelvic Floor Questionnaire
It will be used to assess the bladder symptoms of pelvic floor dysfunction for all females in the three groups. This section will be scored 0-45, with higher scores meaning more dysfunction
Measured: 1 month
Bowel section of the Australian Pelvic Floor Questionnaire
It will be used to assess the bowel symptoms of pelvic floor dysfunction for all females in the three groups. This section will be scored 0-34, with higher scores meaning more dysfunction
Measured: 1 month
36-Item Short Form Survey Instrument (SF-36)
The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health across eight multi-item dimensions, covering functional status, well-being, and overall health evaluation, each associated with 2-10 possible answers. The response to each question is extrapolated to a standardized set of answers, and the results are transferred to a scale of 0-100, where 0 represents the worst state of health and 100 represents the best state of health measured
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Abdelraouf Mohamed Mohamed, Cairo University
- Investigators
- Doaa A. Osman, PhD, Study chair, Assistant ProfessorHossam A. Al Din Hussein Kamel, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803173
- Sponsor's protocol ID
- P.T.REC/012/005371
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Activity in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06803173
- Acronym / sponsor ID
- P.T.REC/012/005371
- Conditions
- Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 31 Jan 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 will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).
Detailed description
Dysmenorrhea, marked by painful menstrual cramps, often involves increased PFM tension, spasms, and inflammation, affecting females' quality of life and productivity. The traditional focus has been on investigating the abdominal region in women with PD. However, this new perspective considers that the hormonal changes experienced during the menstrual cycle in PD patients may lead to a heightened sensitivity of the PFM, not just the abdominal area. This suggests that the pain associated with PD may have a more widespread impact on the pelvic region rather than being localized to the abdomen. Pelvic floor myofascial trigger points (MTrPs) may also exacerbate menstrual pain through the neural pathway.
There is a critical gap in the literature regarding the nature of the association between dysmenorrhea and PFM activity in this population. Yet, it is unknown whether the pain is a cause or result of increased PFM tone, and the nature of the association between menstrual pain and PFM tone in women with PD is also unknown.
So, this study utilizes transabdominal ultrasound (TAU) to examine PFM activity in PD, aiming to clarify how PFM activity contributes to menstrual pain. Understanding these dynamics could lead to preventive strategies and educational efforts highlighting the role of pelvic floor interventions in managing dysmenorrhea, potentially improving treatment methods and overall women's health management.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group of mild primary dysmenorrhea | – | Other: No interventionIt will consist of 26 females with mild dysmenorrhea (WaLIDD score =1-4) |
| group of moderate primary dysmenorrhea | – | Other: No interventionIt will consist of 26 females with moderate dysmenorrhea (WaLIDD score =5-7) |
| group of severe primary dysmenorrhea | – | Other: No interventionIt will consist of 26 females with severe dysmenorrhea (WaLIDD score =8-12) |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Seventy-eight female physiotherapy students with PD will participate in this study. They will be selected randomly from the faculty of physical therapy at Cairo University.
Key inclusion criteria (5 listed)
- They should be virgin, healthy female physiotherapy students with PD.
- They have regular menstruation (3-8 days in duration, with 21-35 days in between).
- Their ages will range from 18 to 25 years old.
- Their body mass index (BMI) will range from 18 to 24.9 kg/m2.
- Their waist-to-hip ratio will be less than 0.8.
Key exclusion criteria (5 listed)
- Any urological or gynecological disorders in the previous 12 weeks (e.g., endometriosis, fibroids).
- Fibromyalgia.
- Severe psychiatric or psychological disorders.
- Those who had taken analgesics in the 12 hours before the assessment.
- Abdominal or pelvic surgery within the past six months.
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 |
|---|---|---|
| No interventionNo intervention | Other | group of mild primary dysmenorrhea, group of moderate primary dysmenorrhea, group of severe primary dysmenorrhea |
Primary outcome
Pelvic floor muscle (PFM) contraction
Time frame: 1 month
Transabdominal ultrasound (TAU) will be used to assess PFM contraction for all females ("cutting off the flow of urine mid-stream") in the three groups.
Pelvic floor muscle (PFM) relaxation
Time frame: 1 month
Transabdominal ultrasound (TAU) will be used to assess PFM relaxation during inspiration for all females.
3 secondary outcomes
Bladder section of the Australian Pelvic Floor Questionnaire
Time frame: 1 month
Bowel section of the Australian Pelvic Floor Questionnaire
Time frame: 1 month
36-Item Short Form Survey Instrument (SF-36)
Time frame: 1 month
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 31 Jan 2025.
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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.
Amira Nagy Abdellatif, PhD contact
Doaa A. Osman, PhD study chair
Assistant Professor
Hossam A. Al Din Hussein Kamel, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Wafaa AM Abdelraouf, B.Sc. (01021080497, wafaaabdelraouf12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle (PFM) contraction (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2025.