NCT05527639

Brief Summary

This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 26, 2022

Last Update Submit

August 4, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • incontinence severity index (ISI) tool

    questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence

    Week 0

  • incontinence severity index (ISI) tool

    questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence

    Week 12

  • pelvic floor muscle strength

    physiotherapist report from digital palpation and perineometry

    week 0

  • pelvic floor muscle strength

    physiotherapist report from digital palpation and perineometry

    week 12

Study Arms (2)

intervention group during study

OTHER

all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior.

Behavioral: strength training program

control group during study

OTHER

all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats

Behavioral: strength training program

Interventions

12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises

control group during studyintervention 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
  • over eighteen years of age
  • suffer from stress urinary incontinence
  • did not perform Kegel exercises
  • had no experience in regular resistance/strength training
  • completed a physical activity readiness questionnaire (PAR-Q) form.

You may not qualify if:

  • pregnancy, 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
SINGLE GROUP
Model Details: A comparative study using data from 2 separate studies. Data used for the resistance training (RT) group from a foundational single cohort that investigated impact of RT on stress urinary incontinence (SUI) in a group of women participating in a RT program who had not previously done Kegel exercises (KE). New data for the KE+RT group was from 2 consecutive studies where the women completed a program of supervised / unsupervised KE. These 19 women took part in 12 weeks of RT to compare against the KE group. The findings of two separate studies in which the effect of RT on SUI and pelvic floor muscle strength was compared between women who completed 12 weeks of RT with or without prior KE. The RT group consisted of 14 women who did not have an experience in RT or KE and completed 12 weeks of RT. Women in the KE plus RT group (n=19) completed 12 weeks of Kegel exercise under the supervision of a qualified pelvic floor specialist; then completed the identical RT program as the RT group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 2, 2022

Study Start

May 18, 2019

Primary Completion

December 18, 2019

Study Completion

December 18, 2019

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations