Pelvic Muscle Strength and FunctionPFMNCT06820801
Assessment of PFM Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers
An observational study of Pelvic Muscle Strength and Function, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Pelvic Muscle Strength and Function
- What is being tested?
- pelvic floor muscles strength and function
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 10 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: women aged between 30 and 50 years old diagnosed with cervix or rectal cancers and will be treated with preoperative radiotherapy for 5 weeks
Who may be able to join
- women between 30 -50 years old
- diagnosed with cervix or rectal cancers
- married
- will be treated with preoperative radiotherapy for at least 5 weeks
- had not any pelvic operations in the past
Who cannot join
- un married women
- Age below 30 or above 50 years old
- has another type of pelvic tumors
- has any metastasis
- had any pelvic surgeries
- will be treated with short course radiotherapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Elahrar oncology center and zagazeg university oncology center
Zagazeg, Alsharkia, 44511
About this study
Official title: Assessment of Pelvic Floor Muscles Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers
Assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers
Read the detailed description
Evaluate the impact of radiotherapy treament on pelvic floor muscles strength and function in women with cervical and rectal cancers
- Conditions
- Pelvic Muscle Strength and Function
- Being tested
- pelvic floor muscles strength and function
- Keywords
- pelvic floor muscles - radiotherapy - pelvic cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscles strength and functionOther
using pressure perineometer to evaluate pelvic floor muscles strength and using PFDI to evaluate pelvic floor muscles function
What is being measured
The primary outcome is the main question the study is designed to answer.
PFM strength and function
Pelvic floor muscles strength and function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Jan 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Muscle Strength and FunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hassan Khalled Abotaleb, Cairo University
- Investigators
- Elham Shahat Hassan, Lecturer of physical therapy, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820801
- Sponsor's protocol ID
- 0237617692
- Acronym
- PFM
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pelvic Floor Muscles Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers
- ClinicalTrials.gov ID
- NCT06820801
- Acronym / sponsor ID
- PFM / 0237617692
- Conditions
- Pelvic Muscle Strength and Function
- Keywords
- pelvic floor muscles - radiotherapy - pelvic cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 11 Feb 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.
Assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers
Detailed description
Evaluate the impact of radiotherapy treament on pelvic floor muscles strength and function in women with cervical and rectal cancers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women aged between 30 and 50 years old diagnosed with cervix or rectal cancers and will be treated with preoperative radiotherapy for 5 weeks
Key inclusion criteria (5 listed)
- women between 30 -50 years old
- diagnosed with cervix or rectal cancers
- married
- will be treated with preoperative radiotherapy for at least 5 weeks
- had not any pelvic operations in the past
Key exclusion criteria (6 listed)
- un married women
- Age below 30 or above 50 years old
- has another type of pelvic tumors
- has any metastasis
- had any pelvic surgeries
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 |
|---|---|---|
| pelvic floor muscles strength and functionusing pressure perineometer to evaluate pelvic floor muscles strength and using PFDI to evaluate pelvic floor muscles function | Other | – |
Primary outcome
PFM strength and function
Time frame: 3 months
Pelvic floor muscles strength and function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Elham Shahat Hassan, Lecturer of physical therapy study director
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 Pelvic Muscle Strength and Function, 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 6 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: finished, as of the sponsor's last update on 26 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFM strength and function (time frame: 3 months). 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 26 Feb 2025.