NCT05410899

Brief Summary

The aim of the study is investigation of the effectiveness of Pelvic Floor Health Education and exercise program in women with Urinary Incontinence. Women diagnosed with both stress and mixed type urinary incontinence were included the study. Pelvic Floor Health Education and exercise program were applied to women for 12 weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 4, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 6, 2022

Last Update Submit

June 7, 2022

Conditions

Keywords

urinary incontinenceexercisepelvic floorhealth education

Outcome Measures

Primary Outcomes (1)

  • Incontinence severity

    urinary incontinence severity changes frequency of incontinence, using Sandvik severity scale quantity of incontinence, type and time of incontinence, also using voiding diary for three days composed of fluid intake time, voiding time, urinary incontinence time and amount

    3 month

Secondary Outcomes (1)

  • Life style

    3 month

Study Arms (3)

Pelvic Floor Health Education

Education will compose presentation about women health, urinary incontinence, teaching anatomy of the pelvic floor and bladder training

Other: exercise

Pelvic Floor Health Education and Exercise Program

pelvic floor health education and exercise of pelvic floor muscles for 12 weeks

Other: exercise

Control

This goup will continue routine treatment such as medication usage

Other: exercise

Interventions

Women with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease

Also known as: pelvic floor health education
ControlPelvic Floor Health EducationPelvic Floor Health Education and Exercise Program

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsUrinary incontinence is more common in women than men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The ages between 18 -65 women with urinary incontinence, applying pelvic floor muscle exercise

You may qualify if:

  • The ages between 18-65 with urinary incontinence
  • Volunteer women who can regularly apply the Pelvic floor muscle exercise program

You may not qualify if:

  • Having pelvic organ prolapse (Stage≥2),
  • Women who are in the neonatal and postnatal period (up to 3 months after birth),
  • Situations that will prevent evaluation or communication (cognitive problems, etc.).
  • Having a neurological disorder,having urinary tract infection,
  • Those who received urinary incontinence treatment or had an operation, • Women who have received training on the pelvic floor before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University Hospital

Sanliurfa, Turkey/Şanlıurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary IncontinencePelvic Floor DisordersMotor ActivityHealth Education

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc Physiotherapist

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 8, 2022

Study Start

June 4, 2022

Primary Completion

September 26, 2022

Study Completion

September 30, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations