Urinary IncontinenceUNITSNCT03057834
The Urinary Incontinence Treatment Study
A study testing Pelvic floor muscle exercise in people with Urinary Incontinence and Sarcopenia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Sarcopenia
- What is being tested?
- Pelvic floor muscle exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 29 Jan 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women
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.
Read the detailed 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 they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.
Investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit.
- Conditions
- Urinary Incontinence, Sarcopenia
- Being tested
- Pelvic floor muscle exercise
- Medical subject headings
- Urinary Incontinence, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle exerciseBehavioural
Standardized pelvic floor muscle exercise regimen
| Study group | Role | What they receive |
|---|---|---|
| Functionally impaired | Active comparator | Women with urinary incontinence and short physical performance battery score of <9 Receives: Behavioral: Pelvic floor muscle exercise |
| Functionally normal | Placebo comparator | Women with urinary incontinence and short physical performance battery score of > 10 Receives: Behavioral: Pelvic floor muscle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Measured: Baseline
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Measured: week 6
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Measured: week 12
Secondary outcomes (4)
Power of Contractions
measurement of strength using perineometer
Measured: week 12
Endurance
measure of how long they can hold contraction
Measured: week 12
Repetition of Contractions
how many repetitions can they sustain
Measured: week 12
Number of Fast Contractions
number of fast contractions that can be repeated
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Mar 2017
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be determined based on the score on the SPPB.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Candace Parker-Autry, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057834
- Sponsor's protocol ID
- IRB00038710
- Other IDs
- R03AG056460
- Acronym
- UNITS
- Status last verified
- Jan 2021
- First submitted
- 10 Feb 2017
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35852275