NCT05375344

Brief Summary

A prospective, two-arm randomized clinical trial utilizing a multidimensional intervention to reduce falls in older women with Urinary Urge Incontinence. The intervention consist of general balance and strength training, bladder training and urge suppression, and home hazard assessments. The control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress92%
Jun 2022Sep 2026

First Submitted

Initial submission to the registry

May 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

June 9, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

May 10, 2022

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in number of falls between the baseline visit and 1 year

    number of falls reported in a falls diary

    12 months

Secondary Outcomes (1)

  • Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year

    12 months

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

Participants in this group will participate in the home-based exercise group intervention that consists of general balance and strength training, bladder training and urge suppression, and home hazard assessments.

Behavioral: Exercise Group

Control Group

NO INTERVENTION

Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.

Interventions

Exercise GroupBEHAVIORAL

Home-based exercise group intervention

Exercise Group

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Female
  • or older
  • Living independently in the community
  • Willingness to be randomized.
  • Ability to read and understand English
  • Be able to provide informed consent
  • Low physical activity (physically active for 30 minutes or more less than or equal to 2 days per week on average over the past 6 months) per PAS
  • Ambulatory (defined as patient not confined to bed or wheelchair OR ability to walk with or without an assistive device)
  • Self-reported moderate to severe urge-predominant UI based on the ICIQ-SF \> 6 (Q 1+2+3)
  • Not planning to initiate new UI or overactive bladder (OAB) treatment during the study duration
  • Capable of participation in an exercise program without exacerbating any pre-existing condition(s), as determined by the study PI or designee

You may not qualify if:

  • Pelvic organ prolapse passed the hymen (per patient report)
  • Undergoing active treatment for cancer (other than non-melanoma skin cancer)
  • Uncorrected visual or hearing loss.
  • Other urinary conditions or procedures that may affect continence status for example: urethral diverticulum, previous augmentation cystoplasty
  • Progressive neurodegenerative disease e.g. Parkinson's disease, multiple sclerosis per patient report
  • History of stroke or carotid sensitivity (i.e. syncopal falls) per patient report
  • Unstable cardiac disease per patient report
  • Fracture or joint replacement within the last six months per patient report
  • Significant cognitive impairment (defined as a modified TICs score of \< 27)
  • Per PI discretion, participant cannot enroll in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Andy UU, Newman DK, Wyman JF, Klusaritz H, Walsh W, Shou H, Koepler N, Schmitz KH, Reaves S, Arya L, Brown RT. The Mobility and Voiding Exercises in Older Women with Urinary Incontinence (MoVEonUp) randomized controlled trial: study protocol and rationale. BMC Geriatr. 2024 Dec 4;24(1):994. doi: 10.1186/s12877-024-05552-7.

MeSH Terms

Conditions

Urinary Incontinence, Urge

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

  • Uduak U Andy, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 16, 2022

Study Start

June 9, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations