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NCT Number: NCT06803173

Pelvic Floor Muscle Activity in Primary Dysmenorrhea

This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).

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Key information

Age range

19 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Giza, Egypt

Location contact

Amira Nagy Abdellatif, PhD

CONTACT

Wafaa AM Abdelraouf Mohamed, B.Sc.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. Pelvic floor muscle (PFM) relaxation

    Time frame: 1 month

    Transabdominal ultrasound (TAU) will be used to assess PFM relaxation during inspiration for all females.

Secondary outcomes

  1. Bladder section of the Australian Pelvic Floor Questionnaire

    Time frame: 1 month

    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

  2. Bowel section of the Australian Pelvic Floor Questionnaire

    Time frame: 1 month

    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

  3. 36-Item Short Form Survey Instrument (SF-36)

    Time frame: 1 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Nagy Abdellatif, PhD

CONTACT

Wafaa AM Abdelraouf, B.Sc.

CONTACT

[email protected]

01021080497

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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