NCT05677841

Brief Summary

The aim of this study is to examine the effects of spinal stabilization exercises focusing on the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions, quality of life and perception of recovery in women with overactive bladder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

December 29, 2022

Last Update Submit

July 17, 2023

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Overactive bladder symptoms

    The Overactive Bladder Questionnaire -V8 will be used for the overactive bladder symptoms severity. It has 8 items and the total score can range from 0 to 40. As the score increases, the severity of symptoms increases.

    change from baseline at 8 weeks

Secondary Outcomes (7)

  • Bladder function

    change from baseline at 8 weeks

  • Urgency severity

    change from baseline at 8 weeks

  • Spinal stability

    change from baseline at 8 weeks

  • Pelvic floor muscle function

    change from baseline at 8 weeks

  • Life Quality

    change from baseline at 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations

Other: Stabilization exercise+lifestyle recommendation

Control group

ACTIVE COMPARATOR

Control group will be given lifestyle recommendations

Other: lifestyle recommendations

Interventions

Stabilization exercise+lifestyle recommendationOTHER

Exercise program was given both spinal stabilization exercises focusing on the pelvic floor 3 days a week for eight weeks and a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )

Exercise group
lifestyle recommendationsOTHER

The control group will be given a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with overactive bladder
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65
  • Women with a diagnosis of overactive bladder
  • Women who volunteered to participate in the study

You may not qualify if:

  • Women with only stress urinary incontinence
  • Presence of advanced pelvic organ prolapse
  • Having a mental problem that will prevent cooperation in assessment and/or practices
  • Women with the presence of a malignant condition
  • Concomitant neurological disease and/or neurogenic bladder
  • Presence of infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Esenboğa Külliyesi, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic 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

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

December 29, 2022

First Posted

January 10, 2023

Study Start

January 15, 2023

Primary Completion

March 15, 2023

Study Completion

May 25, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

TU(1)