NCT03057834: UNITS

The Urinary Incontinence Treatment Study

Completed NA Results posted Last updated 10 November 2025

What this trial tests

NA trial testing Pelvic floor muscle exercise in Urinary Incontinence in 70 participants. Completed in 29 January 2020.

Timeline

1 March 2017

Primary endpoint
29 January 2020

29 January 2020

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	1 March 2017
Primary completion	29 January 2020
Estimated completion	29 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Pelvic floor muscle exercise

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →
• Sarcopenia — all drugs for Sarcopenia →

Sponsor

Wake Forest University Health Sciences

Who can join

70 and older, female only, with Urinary Incontinence or Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Urinary Incontinence Episodes Primary · Baseline

Using a three-day voiding diary

Group	Value	95% CI
Functionally Impaired	4.3	± 0.6
Functionally Normal	2.7	± 0.6

Number of Urinary Incontinence Episodes Primary · week 6

Using a three-day voiding diary

Group	Value	95% CI
Functionally Impaired	3.4	± 0.6
Functionally Normal	2.3	± 0.6

Number of Urinary Incontinence Episodes Primary · week 12

Using a three-day voiding diary

Group	Value	95% CI
Functionally Impaired	3.5	± 0.6
Functionally Normal	2.4	± 0.6

Power of Contractions Secondary · week 12

measurement of strength using perineometer

Group	Value	95% CI
Functionally Impaired	19.3	± 13.3
Functionally Normal	29.3	± 16

Endurance Secondary · week 12

measure of how long they can hold contraction

Group	Value	95% CI
Functionally Impaired	4.4	± 2.0
Functionally Normal	4.7	± 1.9

Repetition of Contractions Secondary · week 12

how many repetitions can they sustain

Group	Value	95% CI
Functionally Impaired	9.1	± 1.9
Functionally Normal	8.8	± 1.9

Number of Fast Contractions Secondary · week 12

number of fast contractions that can be repeated

Group	Value	95% CI
Functionally Impaired	4.3	± 1.7
Functionally Normal	4.7	± 1.5

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The geriatric incontinence syndrome: Characterizing geriatric incontinence in older women.
   Parker-Autry C, Neiberg RH, Leng I, Colombo L, et al · · 2021 · cited 8× · PMID 34519024 · DOI 10.1111/jgs.17374
2. Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence.
   Parker-Autry C, Neiberg R, Leng XI, Matthews CA, et al · · 2022 · cited 1× · PMID 35852275 · DOI 10.1097/aog.0000000000004852