- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05833685
Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning
September 24, 2023 updated by: Deraya University
The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages.
It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse.
One potential cause of FSD is muscular weakness or changes in the core muscles.
These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD.
Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minia
-
Minya, Minia, Egypt
- Deraya university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
100 patients were distributed randomly into two groups.
Female sexual dysfunction group and another group is normal females.
Two group will be measure Transverses muscle ratio, Multifidus muscle ratio ,diaphragm excursion and force of contraction of pelvic floor muscles by ultrasound imaging, VLQ and FSFI questionnaires for female sexual function VLQ and FSFI questionnaires for female sexual dysfunction and normal females.
Patients will be examined by radiologist with medical ultrasound imaging
Description
Inclusion Criteria:
- a number of parities ≤ three
- normal vaginal deliveries
Exclusion Criteria:
- History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
- diabetes,
- intrauterine device
- sexual disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Female sexual dysfunction group
|
no intervention
|
Normal females
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragm excursion
Time Frame: 2 months
|
Ultrasound imaging curvilinear transducer
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Force of contraction of pelvic floor muscles
Time Frame: 2 months
|
ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating.
Voluntary PFM contractions' force (strength) of all patients.
It has a good inter-rater reliability for measuring PFM force (ICC, 0.81, 0.7123) respectively, as well as a good intra-rater reliability (ICC,0.98,
0.9841) respectively
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
April 10, 2023
Study Completion (Actual)
April 15, 2023
Study Registration Dates
First Submitted
April 16, 2023
First Submitted That Met QC Criteria
April 16, 2023
First Posted (Actual)
April 27, 2023
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 24, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- P.REC/ 6/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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