NCT03296462

Brief Summary

This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants. The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration 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

Study Start

First participant enrolled

November 3, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

September 18, 2017

Last Update Submit

May 25, 2022

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (2)

  • Feasibility: achieve recruitment of 30 women over 12 months

    Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months

    12 months

  • Feasibility: achieve follow-up for 60% of recruits over 12 months

    Is follow-up complete for 60% of recruits?

    12 months

Secondary Outcomes (7)

  • Pelvic floor muscle strength

    12 & 24 weeks

  • External hip rotator muscle strength

    12 & 24 weeks

  • Diary-reported urinary incontinence

    12 & 24 weeks

  • Incontinence-related quality of life (distress)

    12 & 24 weeks

  • Incontinence-related quality of life (impact)

    12 & 24 weeks

  • +2 more secondary outcomes

Study Arms (3)

Hip external rotation exercise (alone)

EXPERIMENTAL

Standardised hip external rotation exercise training - over 12 week period

Other: Hip external rotation exercise

Hip external rotation + PFM exercises

EXPERIMENTAL

Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period

Other: Hip external rotation exerciseOther: Pelvic floor muscle exercise

pelvic floor muscle exercises (alone)

ACTIVE COMPARATOR

Standardised pelvic floor muscle exercises - over 12 week period (usual care)

Other: Pelvic floor muscle exercise

Interventions

Hip external rotation exerciseOTHER

Standardised HER exercise training by physiotherapist (plus video recording of exercises)

Hip external rotation + PFM exercisesHip external rotation exercise (alone)
Pelvic floor muscle exerciseOTHER

Standardised PFM exercise training by physiotherapist (plus video recording of exercises)

Hip external rotation + PFM exercisespelvic floor muscle exercises (alone)

Eligibility Criteria

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

You may qualify if:

  • Stress urinary incontinence
  • Attending Lois Hole Hospital for Women Urogynecology Clinic
  • Referred for physiotherapy for stress urinary incontinence
  • Able to toilet independently
  • Able to undertake hip rotation exercises
  • Able to speak and read English

You may not qualify if:

  • Urge urinary incontinence
  • Using a pessary
  • Neurological or cognitive impairment
  • Using other treatment for incontinence
  • Unable to complete study forms
  • Unable to understand educational instruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lois Hole Hospital for Women, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

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.

    PMID: 39704322DERIVED

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

  • Sue Ross, PhD

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient and research assistant are blind to next allocation. Outcome assessors (physiotherapist and exercise physiologist) and one investigator are blinded to group of allocation. Statistician will be masked to group of allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 28, 2017

Study Start

November 3, 2016

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

CA(1)