The Urinary Incontinence Treatment Study

NCT03057834 | Completed Results DMC

• 2 other identifiers: IRB00038710R03AG056460
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

Conditions

Urinary Incontinence; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• Number of Urinary Incontinence Episodes

  Using a three-day voiding diary

  Baseline

• Number of Urinary Incontinence Episodes

  Using a three-day voiding diary

  week 6

• Number of Urinary Incontinence Episodes

  Using a three-day voiding diary

  week 12

Secondary Outcomes (4)

• Power of Contractions

  week 12

• Endurance

  week 12

• Repetition of Contractions

  week 12

• Number of Fast Contractions

  week 12

Other Outcomes (17)

• Pelvic Organ Prolapse

  baseline, week 12

• Short Physical Performance Battery (expSPPB)--Gait Speed

  week 12

• 400 Meter Walk

  week 12

Study Arms (2)

Functionally impaired

ACTIVE COMPARATOR

Women with urinary incontinence and short physical performance battery score of \<9

Behavioral: Pelvic floor muscle exercise

Functionally normal

PLACEBO COMPARATOR

Women with urinary incontinence and short physical performance battery score of \> 10

Behavioral: Pelvic floor muscle exercise

Interventions

Pelvic floor muscle exercise BEHAVIORAL

Standardized pelvic floor muscle exercise regimen

Functionally impaired; Functionally normal

Eligibility Criteria

• Age: 70 Years+
• Gender Eligibility Details: Must be born a woman due to the nature of the intervention investigators are studying.
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Women, age 70 years or older
• Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)
• Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
• Willing and able to undergo an extensive physical function evaluation

You may not qualify if:

• Prior surgical intervention for urinary incontinence within the past 12 months
• Hysterectomy within 12 months
• Diagnosis of:
• Pelvic Organ Prolapse beyond the hymenal ring
• Urogenital Fistula
• Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)
• Incomplete Bladder Emptying/Urinary Retention with PVR \>150 ml (measured by bladder scan)
• Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound
• Having significant cognitive impairment or dementia
• Unsafe to exercise (severe cardiopulmonary disease)
• Unable/unwilling to provide informed consent
• Determined otherwise ineligible by the principal investigator

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Parker-Autry C, Neiberg R, Leng XI, Matthews CA, Dumoulin C, Kuchel G, Kritchevsky SB. Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence. Obstet Gynecol. 2022 Aug 1;140(2):243-251. doi: 10.1097/AOG.0000000000004852. Epub 2022 Jul 6.

  PMID: 35852275 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Sarcopenia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Candace Parker-Autry, MD
• Organization: Wake Forest University School of Medicine

candace.parkerautry@wfusm.edu

336-716-3779

Study Officials

• Candace Parker-Autry, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be determined based on the score on the SPPB.

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2017
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)