Assessment of PFM Strength and Function After Radiotherap... | NCT06820801

Studies
Assessment of PFM Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers

NCT06820801

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 26, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pelvic Muscle Strength and Function

Interventions

pelvic floor muscles strength and function

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2024Actual

Primary Completion Date

Dec 10, 2024Actual

Completion Date

Dec 10, 2024Actual

First Submitted Date

Feb 6, 2025

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pelvic floor muscles strength and function	Other	using pressure perineometer to evaluate pelvic floor muscles strength and using PFDI to evaluate pelvic floor muscles function

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFM strength and function	Pelvic floor muscles strength and function	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elham Shahat Hassan, Lecturer of physical therapy		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elahrar oncology center and zagazeg university oncology center		Zagazeg	Alsharkia	44511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000085542	Functional Status

Ancestor Terms

ID	Term
D000203	Activities of Daily Living
D012046	Rehabilitation
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided