Stress Urinary IncontinenceNCT01337193
Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
A study testing Pelvic floor exercises with biofeedback and Pelvic floor muscle exercises in people with Stress Urinary Incontinence, run by Texas Woman's University at 1 site in United States.
Trial summary
The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor exercises with biofeedback and Pelvic floor muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2014
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women will need to be 20 years or older
- diagnosed with stress urinary incontinence (SUI).
Who cannot join
- women with:
- urge or mixed incontinence
- pelvic organ prolapse
- previous surgical treatment for incontinence
- current treatment for SUI (including medications)
- current pregnancy
Show all 11Show fewer
- six months or less postpartum
- body mass index of ≥ 30
- recurrent vulvovaginitis
- current/recurrent urinary tract infections (UTI)
- non-English speaking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence
The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.
The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.
All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.
Read the detailed description
This study has been terminated.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor exercises with biofeedback, Pelvic floor muscle exercises
- Keywords
- stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging
- Medical subject headings
- Urinary Incontinence, Stress, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercises with biofeedbackOther
Exercises will be performed with assistance of biofeedback cueing
Pelvic floor muscle exercisesOther
Exercises will b performed with verbal cueing of investigator.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle exercises | Active comparator | Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor. Receives: Other: Pelvic floor muscle exercises |
| Pelvic floor exercises with biofeedback | Experimental | Pelvic floor exercises will be performed with biobeedback cueing. Receives: Other: Pelvic floor exercises with biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.
Measured: baseline, 4 weeks, and 8 weeks
Secondary outcomes (2)
Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study
Incidence of incontinent episodes will be measured using a 7-day bladder diary
Measured: Baseline, 4 weeks, and 8 weeks
Change in quality of life from the baseline to the midpoint and completion of the study
Quality of life will be measured using the I-QOL questionnaire
Measured: Baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Principal investigator has decided not to continue her PhD studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Trudelle-Jackson, Texas Woman's University
- Investigators
- Elaine Trudell-Jackson, PT, PhD, Study chair, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337193
- Sponsor's protocol ID
- SUI 16333
- Status last verified
- Nov 2014
- First submitted
- 1 Apr 2011
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01337193
- Acronym / sponsor ID
- SUI 16333
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator has decided not to continue her PhD studies.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Apr 2011 (estimated)
- 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 overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.
The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.
All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.
Detailed description
This study has been terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle exercises | Active comparator | Other: Pelvic floor muscle exercisesThree pelvic floor muscle exercises will be performed with verbal cueing from the instructor. |
| Pelvic floor exercises with biofeedback | Experimental | Other: Pelvic floor exercises with biofeedbackPelvic floor exercises will be performed with biobeedback cueing. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women will need to be 20 years or older
- diagnosed with stress urinary incontinence (SUI).
Key exclusion criteria (11 listed)
- urge or mixed incontinence
- pelvic organ prolapse
- previous surgical treatment for incontinence
- current treatment for SUI (including medications)
- current pregnancy
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 |
|---|---|---|
| Pelvic floor exercises with biofeedbackExercises will be performed with assistance of biofeedback cueing | Other | Pelvic floor exercises with biofeedback |
| Pelvic floor muscle exercisesExercises will b performed with verbal cueing of investigator. | Other | Pelvic floor muscle exercises |
Primary outcome
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
Time frame: baseline, 4 weeks, and 8 weeks
Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.
2 secondary outcomes
Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study
Time frame: Baseline, 4 weeks, and 8 weeks
Change in quality of life from the baseline to the midpoint and completion of the study
Time frame: Baseline, 4 weeks, and 8 weeks
Results and safety
The study was stopped early (reason given: Principal investigator has decided not to continue her PhD studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Elaine Trudell-Jackson, PT, PhD study chair
Texas Woman's 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 Pelvic floor exercises with biofeedback and Pelvic floor muscle exercises in people with Stress Urinary Incontinence, run by Texas Woman's 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 2 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: stopped early, as of the sponsor's last update on 14 Nov 2014. 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 was stopped early (reason given: Principal investigator has decided not to continue her PhD studies.). Results are not available in the source record.
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?
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study (time frame: baseline, 4 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2014.