NCT05193435

Brief Summary

The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 2, 2022

Last Update Submit

January 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence severity

    Urinary incontinence severity will be measured with A 1-hour pad test

    change from baseline at 8 weeks

Secondary Outcomes (8)

  • Urinary symptoms

    change from baseline at 8 weeks

  • Life quality

    change from baseline at 8 weeks

  • Pelvic floor muscle activation response

    change from baseline at 8 weeks

  • Pelvic floor muscle strength

    change from baseline at 8 weeks

  • Core stability

    change from baseline at 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Pelvic floor exercise group

EXPERIMENTAL

Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks

Other: Pelvic floor exercises

Stabilization exercise group

ACTIVE COMPARATOR

Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks

Other: Stabilization exercises

Interventions

Pelvic floor exercises for types I and II muscle fibers will be performed

Pelvic floor exercise group

Lumbar spinal stabilization exercises will be performed

Stabilization exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study

You may not qualify if:

  • Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 2, 2022

First Posted

January 14, 2022

Study Start

January 15, 2022

Primary Completion

December 15, 2022

Study Completion

June 15, 2023

Last Updated

January 14, 2022

Record last verified: 2022-01