Urinary IncontinenceFAMENCT03166150
Functional Assessment and Muscle Evaluation Through Exercise Trial
A study testing Multi-modal rehabilitation program and Pelvic Floor Physical therapy in people with Urinary Incontinence, run by Howard University at 1 site in United States.
Trial summary
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Multi-modal rehabilitation program and Pelvic Floor Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women ≥ 65 years older
- Symptomatic UI
- Symptoms ≥ 3 months
- Episodes of UI on 3-day bladder diary
- Stress, urgency, and mixed UI
Who cannot join
- Women unable to have functional assessment and/or complete bladder diary
- Impaired mental status (MMSE <25)
- Post-void residual ≥ 150 ml
- Non-ambulatory (wheelchair bound), unable to complete mobility assessments
- Hematuria
- Urinary tract infection
Show all 11Show fewer
- Continuous Incontinence
- Pelvic Organ prolapse > stage 2
- Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
- Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
- Women with contraindications to undergo MRI including claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
Official title: Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.
Read the detailed description
This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence.
The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.
The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.
- Conditions
- Urinary Incontinence
- Being tested
- Multi-modal rehabilitation program, Pelvic Floor Physical therapy
- Keywords
- Urinary Incontinence, Pelvic Floor Disorder, Pelvic Floor Muscle, Strength, Disability, Aging, Atrophy, Exercise, Magnetic Resonance Imaging, Fatty Infiltration, Physical Therapy, Multi-modal Rehabilitation, Stress Urinary Incontinence, Urge Urinary Incontinence, Mixed Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders, Atrophy, Motor Activity, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal rehabilitation programOther
Patients will receive 12 weeks of exercises.
Pelvic Floor Physical therapyOther
Pelvic Floor Physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Multi-modal rehabilitation program | Experimental | 12 weeks of various exercises Receives: Other: Multi-modal rehabilitation program |
| Pelvic Floor Physical therapy | Active comparator | 12 weeks of standard pelvic floor physical therapy Receives: Other: Pelvic Floor Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of UI episodes
The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.
Measured: 12 weeks
Secondary outcomes (2)
muscle strength
functional assessment
Measured: 12 weeks
muscle quality
MRI evaluation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start25 Apr 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- National Hispanic Council on Aging (NHCOA)
- Responsible party
- Principal investigator, Tatiana Sanses, Howard University
- Investigators
- Tatiana Sanses, M.D., Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166150
- Sponsor's protocol ID
- 18-MED-21
- Acronym
- FAME
- Status last verified
- Sep 2020
- First submitted
- 23 May 2017
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunskaar S, Arnold EP, Burgio K, Diokno AC, Herzog AR, Mallett VT. Epidemiology and natural history of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(5):301-19. doi: 10.1007/s001920070021.
PubMed 11052566Huang AJ, Brown JS, Thom DH, Fink HA, Yaffe K; Study of Osteoporotic Fractures Research Group. Urinary incontinence in older community-dwelling women: the role of cognitive and physical function decline. Obstet Gynecol. 2007 Apr;109(4):909-16. doi: 10.1097/01.AOG.0000258277.01497.4b.
PubMed 17400853Hirsch JF, Rose CS, Pierre-Kahn A, Renier D, Hoppe-Hirsch E. Neurosurgery with craniotomy and CT stereotactic guidance in the treatment of intracerebral space-occupying lesions. Childs Nerv Syst. 1990 Sep;6(6):323-6. doi: 10.1007/BF00298277.
PubMed 2257544Harris SS, Link CL, Tennstedt SL, Kusek JW, McKinlay JB. Care seeking and treatment for urinary incontinence in a diverse population. J Urol. 2007 Feb;177(2):680-4. doi: 10.1016/j.juro.2006.09.045.
PubMed 17222656Hannestad YS, Rortveit G, Hunskaar S. Help-seeking and associated factors in female urinary incontinence. The Norwegian EPINCONT Study. Epidemiology of Incontinence in the County of Nord-Trondelag. Scand J Prim Health Care. 2002 Jun;20(2):102-7.
PubMed 12184708Morrill M, Lukacz ES, Lawrence JM, Nager CW, Contreras R, Luber KM. Seeking healthcare for pelvic floor disorders: a population-based study. Am J Obstet Gynecol. 2007 Jul;197(1):86.e1-6. doi: 10.1016/j.ajog.2007.02.051.
PubMed 17618770Stickley A, Santini ZI, Koyanagi A. Urinary incontinence, mental health and loneliness among community-dwelling older adults in Ireland. BMC Urol. 2017 Apr 8;17(1):29. doi: 10.1186/s12894-017-0214-6.
PubMed 28388898Yip SO, Dick MA, McPencow AM, Martin DK, Ciarleglio MM, Erekson EA. The association between urinary and fecal incontinence and social isolation in older women. Am J Obstet Gynecol. 2013 Feb;208(2):146.e1-7. doi: 10.1016/j.ajog.2012.11.010. Epub 2012 Nov 15.
PubMed 23159696Jerez-Roig J, Santos MM, Souza DL, Amaral FL, Lima KC. Prevalence of urinary incontinence and associated factors in nursing home residents. Neurourol Urodyn. 2016 Jan;35(1):102-7. doi: 10.1002/nau.22675. Epub 2014 Oct 12.
PubMed 25307780Ko Y, Lin SJ, Salmon JW, Bron MS. The impact of urinary incontinence on quality of life of the elderly. Am J Manag Care. 2005 Jul;11(4 Suppl):S103-11.
PubMed 16161383Thom DH, Haan MN, Van Den Eeden SK. Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality. Age Ageing. 1997 Sep;26(5):367-74. doi: 10.1093/ageing/26.5.367.
PubMed 9351481Goode PS, Burgio KL, Richter HE, Markland AD. Incontinence in older women. JAMA. 2010 Jun 2;303(21):2172-81. doi: 10.1001/jama.2010.749.
PubMed 20516418Roe B, Flanagan L, Jack B, Barrett J, Chung A, Shaw C, Williams K. Systematic review of the management of incontinence and promotion of continence in older people in care homes: descriptive studies with urinary incontinence as primary focus. J Adv Nurs. 2011 Feb;67(2):228-50. doi: 10.1111/j.1365-2648.2010.05481.x. Epub 2010 Nov 24.
PubMed 21105895Roe B, Flanagan L, Jack B, Shaw C, Williams K, Chung A, Barrett J. Systematic review of descriptive studies that investigated associated factors with the management of incontinence in older people in care homes. Int J Older People Nurs. 2013 Mar;8(1):29-49. doi: 10.1111/j.1748-3743.2011.00300.x. Epub 2011 Dec 19.
PubMed 22182302Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.
PubMed 24334159
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
- ClinicalTrials.gov ID
- NCT03166150
- Acronym / sponsor ID
- FAME / 18-MED-21
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Pelvic Floor Disorder, Pelvic Floor Muscle, Strength, Disability, Aging, Atrophy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- National Hispanic Council on Aging (NHCOA)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.
Detailed description
This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence.
The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.
The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-modal rehabilitation program | Experimental | Other: Multi-modal rehabilitation program12 weeks of various exercises |
| Pelvic Floor Physical therapy | Active comparator | Other: Pelvic Floor Physical therapy12 weeks of standard pelvic floor physical therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Women ≥ 65 years older
- Symptomatic UI
- Symptoms ≥ 3 months
- Episodes of UI on 3-day bladder diary
- Stress, urgency, and mixed UI
Key exclusion criteria (11 listed)
- Women unable to have functional assessment and/or complete bladder diary
- Impaired mental status (MMSE <25)
- Post-void residual ≥ 150 ml
- Non-ambulatory (wheelchair bound), unable to complete mobility assessments
- Hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal rehabilitation programPatients will receive 12 weeks of exercises. | Other | Multi-modal rehabilitation program |
| Pelvic Floor Physical therapyPelvic Floor Physical therapy | Other | Pelvic Floor Physical therapy |
Primary outcome
Reduction of UI episodes
Time frame: 12 weeks
The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.
2 secondary outcomes
muscle strength
Time frame: 12 weeks
muscle quality
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 11052566Hunskaar S, Arnold EP, Burgio K, Diokno AC, Herzog AR, Mallett VT. Epidemiology and natural history of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(5):301-19. doi: 10.1007/s001920070021.
- Background: PubMed 17400853Huang AJ, Brown JS, Thom DH, Fink HA, Yaffe K; Study of Osteoporotic Fractures Research Group. Urinary incontinence in older community-dwelling women: the role of cognitive and physical function decline. Obstet Gynecol. 2007 Apr;109(4):909-16. doi: 10.1097/01.AOG.0000258277.01497.4b.
- Background: PubMed 2257544Hirsch JF, Rose CS, Pierre-Kahn A, Renier D, Hoppe-Hirsch E. Neurosurgery with craniotomy and CT stereotactic guidance in the treatment of intracerebral space-occupying lesions. Childs Nerv Syst. 1990 Sep;6(6):323-6. doi: 10.1007/BF00298277.
- Background: PubMed 17222656Harris SS, Link CL, Tennstedt SL, Kusek JW, McKinlay JB. Care seeking and treatment for urinary incontinence in a diverse population. J Urol. 2007 Feb;177(2):680-4. doi: 10.1016/j.juro.2006.09.045.
- Background: PubMed 12184708Hannestad YS, Rortveit G, Hunskaar S. Help-seeking and associated factors in female urinary incontinence. The Norwegian EPINCONT Study. Epidemiology of Incontinence in the County of Nord-Trondelag. Scand J Prim Health Care. 2002 Jun;20(2):102-7.
- Background: PubMed 17618770Morrill M, Lukacz ES, Lawrence JM, Nager CW, Contreras R, Luber KM. Seeking healthcare for pelvic floor disorders: a population-based study. Am J Obstet Gynecol. 2007 Jul;197(1):86.e1-6. doi: 10.1016/j.ajog.2007.02.051.
- Background: PubMed 28388898Stickley A, Santini ZI, Koyanagi A. Urinary incontinence, mental health and loneliness among community-dwelling older adults in Ireland. BMC Urol. 2017 Apr 8;17(1):29. doi: 10.1186/s12894-017-0214-6.
- Background: PubMed 23159696Yip SO, Dick MA, McPencow AM, Martin DK, Ciarleglio MM, Erekson EA. The association between urinary and fecal incontinence and social isolation in older women. Am J Obstet Gynecol. 2013 Feb;208(2):146.e1-7. doi: 10.1016/j.ajog.2012.11.010. Epub 2012 Nov 15.
- Background: PubMed 25307780Jerez-Roig J, Santos MM, Souza DL, Amaral FL, Lima KC. Prevalence of urinary incontinence and associated factors in nursing home residents. Neurourol Urodyn. 2016 Jan;35(1):102-7. doi: 10.1002/nau.22675. Epub 2014 Oct 12.
- Background: PubMed 16161383Ko Y, Lin SJ, Salmon JW, Bron MS. The impact of urinary incontinence on quality of life of the elderly. Am J Manag Care. 2005 Jul;11(4 Suppl):S103-11.
- Background: PubMed 9351481Thom DH, Haan MN, Van Den Eeden SK. Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality. Age Ageing. 1997 Sep;26(5):367-74. doi: 10.1093/ageing/26.5.367.
- Background: PubMed 20516418Goode PS, Burgio KL, Richter HE, Markland AD. Incontinence in older women. JAMA. 2010 Jun 2;303(21):2172-81. doi: 10.1001/jama.2010.749.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Sanses, M.D. principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal rehabilitation program and Pelvic Floor Physical therapy in people with Urinary Incontinence, run by Howard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of UI episodes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166150, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.