Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor D... | NCT06063447

Studies
Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?

NCT06063447

Sponsor

Cyprus International University

Status

Completed

Last Update Posted

Oct 2, 2023Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Scoliosis Idiopathic
Pelvic Floor Disorders

Interventions

Examination

Countries

Turkey (Türkiye)

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

Sep 2023

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

May 2, 2023Actual

Primary Completion Date

Sep 4, 2023Actual

Completion Date

Sep 15, 2023Actual

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Sep 27, 2023

First Posted Date

Oct 2, 2023Actual

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

Sep 27, 2023

Last Update Posted Date

Oct 2, 2023Actual

Name	Class
Near East University, Turkey	OTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to investigate relationship between the type and severity of scoliosis and pelvic floor dysfunctions in individuals with adolescent idiopathic scoliosis.

Detailed Description

While a healthy spine has a flat appearance in the axial line in the frontal plane, individuals with scoliosis have lateral flexion to one side and rotation deformity in the horizantal plane. In other words, it is a 3-dimensional problem that causes severe postural disorder in advanced stages, accompanied by lateral flexion of the spine of 10 degrees or more in the frontal plane, axial rotation in the transverse plane and kyphosis-lordosis deformity in the sagittal plane. Especially the "core" region, which is formed by 4 main muscle groups, stabilizes the pelvic organs by balancing intra-abdominal pressure increases and provides spinal stabilization. Studies showing that pelvic floor functions may be affected in normal spinal physiologic curvature changes are available in the literature. However, the relationship between the angle and severity of scoliosis and pelvic floor dysfunctions due to idiopathic scoliosis has not been clearly clarified.

In this context, the study aims to evaluate and compare scoliosis-related parameters (type of scoliosis, cobb angle, axial rotation angle), pelvic floor dynamics and dysfunctions in individuals with idiopathic scoliosis and healthy individuals with the same age group and characteristics.

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

15 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Examination	Other	Posture Evaluation, Scoliosis Examination, Pelvic Floor Assesments

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scoliosis	With X-Ray	10 minutes
Posture Analysis	With Posture Screen Mobile Application	5 minutes
Pelvic Floor Muscle Activity	With Real Time Transabdominal Ultrasound	15 Minutes
Pelvic Floor Dysfunction	With Pelvic Floor Distress Inventory	5 minutes
Dysfunctional Voiding	With Dysfunctional Voiding Scoring System	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those with adolescent idiopathic scoliosis diagnosed above 10' degree,
Under 19 years of age diagnosed with AIS,
Individuals whose consent was obtained from their families to participate in the study

Exclusion Criteria:

Those with congenital scoliosis,
Those with a history of neuromuscular disease,
Diagnosed with any systemic disease other than AIS,
Those with a history of malignancy and/or ongoing treatment,
Those with a history of urogenital diseases and surgical history,
Individuals with previous spinal surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Individuals aged between 11-18 years and followed up in physiotherapy centers that met the inclusion criteria were selected.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salih Angın, Prof.	Cyprus International University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Batuhan Ibrahim		Mersin	Lefkosa	99258	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Perkins, J., Boyer, A., Mcleish, A., & Grossnickle, K. (2012). Idiopathic scoliosis and pelvic floor dysfunction. International Journal of Therapy and Rehabilitation, 19(2), 106-110.
27054800	Background	Meyer I, McArthur TA, Tang Y, McKinney JL, Morgan SL, Richter HE. Pelvic Floor Symptoms and Spinal Curvature in Women. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):219-23. doi: 10.1097/SPV.0000000000000271.
29772989

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D011248	Pregnancy Complications

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques