NCT05529238

Brief Summary

Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence. Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises. The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

August 26, 2022

Last Update Submit

February 3, 2023

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (4)

  • Incontinence severity index (ISI) tool

    self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.

    Week 0

  • Incontinence severity (ISI) index tool

    self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.

    Week 12

  • Pelvic floor assessment from physiotherapist

    pelvic floor muscle strength

    week 0

  • Pelvic floor assessment from physiotherapist

    pelvic floor muscle strength

    week 12

Study Arms (2)

supervised group during study

OTHER

monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry.

Behavioral: biofeedback training

unsupervised group during study

NO INTERVENTION

No intervention. Participants to practice kegel exercises at home.

Interventions

biofeedback trainingBEHAVIORAL

participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home

supervised group during study

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmust be female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being female
  • aged over 18 years
  • suffer from SUI (their subjective disclosure was based on a description provided for their reference)
  • did not perform Kegel exercises
  • be available for duration of 12-week program

You may not qualify if:

  • pregnancy and breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Darwin University

Darwin, Northern Territory, 0909, Australia

Location

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 7, 2022

Study Start

June 18, 2019

Primary Completion

August 18, 2019

Study Completion

August 18, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

AU(1)