Pelvic Floor Muscle Activity in Primary Dysmenorrhea
1 other identifier
observational
77
1 country
1
Brief Summary
This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedJanuary 31, 2025
January 1, 2025
2 months
January 27, 2025
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
1 month
Pelvic floor muscle (PFM) relaxation
Transabdominal ultrasound (TAU) will be used to assess PFM relaxation during inspiration for all females.
1 month
Secondary Outcomes (3)
Bladder section of the Australian Pelvic Floor Questionnaire
1 month
Bowel section of the Australian Pelvic Floor Questionnaire
1 month
36-Item Short Form Survey Instrument (SF-36)
1 month
Study Arms (3)
group of mild primary dysmenorrhea
It will consist of 26 females with mild dysmenorrhea (WaLIDD score =1-4)
group of moderate primary dysmenorrhea
It will consist of 26 females with moderate dysmenorrhea (WaLIDD score =5-7)
group of severe primary dysmenorrhea
It will consist of 26 females with severe dysmenorrhea (WaLIDD score =8-12)
Interventions
No intervention
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Giza, Egypt
Study Officials
- STUDY CHAIR
Doaa A. Osman, PhD
Assistant Professor
- STUDY DIRECTOR
Hossam A. Al Din Hussein Kamel, PhD
Professor
Central Study Contacts
Amira Nagy Abdellatif, PhD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 27, 2025
First Posted
January 31, 2025
Study Start
February 1, 2025
Primary Completion
April 1, 2025
Study Completion
April 15, 2025
Last Updated
January 31, 2025
Record last verified: 2025-01