Urinary IncontinencePhase 4ValUENCT00803959
Value of Urodynamic Evaluation
A Phase 4 study testing Office evaluation and UDS in people with Urinary Incontinence, run by Carelon Research at 10 sites in United States.
Trial summary
Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Office evaluation and UDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2008to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Predominant SUI as evidenced by all of the following:
- Self-reported stress-type UI symptoms, of duration >3 months*
- MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
- Observation of leakage by provocative stress test at any volume
- Eligible for randomization to either treatment group
Show all 14Show fewer
- Eligible for SUI surgery
- Desires non-conservative therapy for SUI
- PVR <150ml by any method. (May repeat once if initial measure is abnormal)
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture
- Available to initiate SUI treatment within 6 weeks of randomization
- Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
- Signed consent form.
- Patient can be rescreened after respective time interval has been met.
Who cannot join
- Age <21 years*
- Currently undergoing or has had recommended treatment of apical or anterior prolapse
- No anterior or apical prolapse > +1 on standing straining prolapse exam
- Pregnant or has not completed child bearing.
- <12 months post-partum*†
- Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
Show all 19Show fewer
- History of pelvic radiation therapy
- Previous incontinence surgery
- Current catheter use
- Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
- Previous (i.e. repaired) or current urethral diverticulum
- Prior augmentation cystoplasty or artificial sphincter
- Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
- Any pelvic surgery within the last 3 months*
- Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
- Participation in another treatment intervention trial that might influence results of this trial.
- A urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject.
- Patient can be rescreened after respective time interval has been met.
- "Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35294
University of Texas Southwestern
Dallas, Texas, 75390
Oakwood Hospital/Cancer Center
Dearborn, Michigan, 48123
Loyola University Medical Center
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Beaumont Hospital
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
University of Texas Health Sciences Center
San Antonio, Texas, 78229-3900
University of California
San Diego, California, 92103
About this study
Official title: A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?
- Conditions
- Urinary Incontinence
- Being tested
- Office evaluation, UDS
- Keywords
- Stress urinary incontinence, Mixed, Urge
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office evaluationOther
Office evaluation
UDSOther
Also called Urodynamics
Urodynamics
| Study group | Role | What they receive |
|---|---|---|
| No UDS | Active comparator | Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only. Receives: Other: Office evaluation |
| UDS | Active comparator | Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery. Receives: Other: Office evaluation; Other: UDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months.
Measured: 12 Months
Secondary outcomes (12)
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.
Measured: Baseline, 12 mos
Patient Global Impression Index
Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants, "How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?" Responses are on a 7-point scale from 1 meaning "very much better" to 7 meaning "very much worse." Values of "very much better" (1) or "much better" (2) were considered to have "perceived improvement" according to this criteria. Values of 3 or greater were not (e.g. "a little better", "no change", "a little worse", "much worse" or "very much worse"). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence.
Measured: 12 Months
Change in Bother as Measured by the UDI
The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Measured: Baseline, 12 Months
Change in Severity as Measured by the ISI
Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Measured: Baseline & 12 Months
Change in MESA Stress Score
The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
Measured: Screen & 12 Months
Change in MESA Urge Score
The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
Measured: Screen & 12 Months
Change in Quality of Life as Measured by the IIQ
Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Measured: Baseline, 12 Months
Change in Quality of Life as Measured by the SF-12
The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.
Measured: Baseline, 12 Months
Change in Severity as Measured by the PGI-S
The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Measured: Baseline & 12 Months
Moderate or Severe Severity as Measured by the PGI-S
The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a "3" corresponding to the "moderate" category or a "4" corresponding to the "severe" category at the 12 month visit.
Measured: 12 Months
Patient Satisfaction With Treatment Outcome
A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.
Measured: 12 Months
Stress Test at 12 Mos
A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.
Measured: Screen and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionJun 2010
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 (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, University of Utah, Beaumont Hospital, Loyola University
- Responsible party
- Sponsor
- Investigators
- Ann Gormley, MD, Study chair, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803959
- Sponsor's protocol ID
- ValUE (completed)
- Acronym
- ValUE
- Status last verified
- Jul 2013
- First submitted
- 5 Dec 2008
- Last updated
- 6 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, Dandreo KJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, Sutkin G, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, Kusek JW, Gormley EA; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012 May 24;366(21):1987-97. doi: 10.1056/NEJMoa1113595. Epub 2012 May 2.
PubMed 22551104Nager CW, Brubaker L, Daneshgari F, Litman HJ, Dandreo KJ, Sirls L, Lemack GE, Richter HE, Leng W, Norton P, Kraus SR, Chai TC, Chang D, Amundsen CL, Stoddard AM, Tennstedt SL; Urinary Incontinence Treatment Network. Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations. Contemp Clin Trials. 2009 Nov;30(6):531-9. doi: 10.1016/j.cct.2009.07.001. Epub 2009 Jul 25.
PubMed 19635587Norton PA, Nager CW, Brubaker L, Lemack GE, Sirls LT, Holley R, Chai TC, Kraus SR, Zyczynski H, Smith B, Stoddard A; Urinary Incontinence Treatment Network. The cost of preoperative urodynamics: A secondary analysis of the ValUE trial. Neurourol Urodyn. 2016 Jan;35(1):81-4. doi: 10.1002/nau.22684. Epub 2014 Oct 18.
PubMed 25327775
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
- ClinicalTrials.gov ID
- NCT00803959
- Acronym / sponsor ID
- ValUE / ValUE (completed)
- Conditions
- Urinary Incontinence
- Keywords
- Stress urinary incontinence, Mixed, Urge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, University of Utah, Beaumont Hospital, Loyola University
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Posted 6 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No UDS | Active comparator | Other: Office evaluationWomen desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only. |
| UDS | Active comparator | Other: Office evaluation, Other: UDSWomen desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female
- Predominant SUI as evidenced by all of the following:
- Observation of leakage by provocative stress test at any volume
- Eligible for randomization to either treatment group
- Eligible for SUI surgery
Key exclusion criteria (19 listed)
- Age <21 years*
- Currently undergoing or has had recommended treatment of apical or anterior prolapse
- No anterior or apical prolapse > +1 on standing straining prolapse exam
- Pregnant or has not completed child bearing.
- <12 months post-partum*†
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 |
|---|---|---|
| Office evaluationOffice evaluation | Other | No UDS, UDS |
| UDSAlso: UrodynamicsUrodynamics | Other | UDS |
Primary outcome
Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
Time frame: 12 Months
Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months.
12 secondary outcomes
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
Time frame: Baseline, 12 mos
Patient Global Impression Index
Time frame: 12 Months
Change in Bother as Measured by the UDI
Time frame: Baseline, 12 Months
Change in Severity as Measured by the ISI
Time frame: Baseline & 12 Months
Change in MESA Stress Score
Time frame: Screen & 12 Months
Change in MESA Urge Score
Time frame: Screen & 12 Months
Change in Quality of Life as Measured by the IIQ
Time frame: Baseline, 12 Months
Change in Quality of Life as Measured by the SF-12
Time frame: Baseline, 12 Months
Change in Severity as Measured by the PGI-S
Time frame: Baseline & 12 Months
Moderate or Severe Severity as Measured by the PGI-S
Time frame: 12 Months
Patient Satisfaction With Treatment Outcome
Time frame: 12 Months
Stress Test at 12 Mos
Time frame: Screen and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22551104Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, Dandreo KJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, Sutkin G, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, Kusek JW, Gormley EA; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012 May 24;366(21):1987-97. doi: 10.1056/NEJMoa1113595. Epub 2012 May 2.
- Results publication: PubMed 19635587Nager CW, Brubaker L, Daneshgari F, Litman HJ, Dandreo KJ, Sirls L, Lemack GE, Richter HE, Leng W, Norton P, Kraus SR, Chai TC, Chang D, Amundsen CL, Stoddard AM, Tennstedt SL; Urinary Incontinence Treatment Network. Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations. Contemp Clin Trials. 2009 Nov;30(6):531-9. doi: 10.1016/j.cct.2009.07.001. Epub 2009 Jul 25.
- Derived from this study: PubMed 25327775Norton PA, Nager CW, Brubaker L, Lemack GE, Sirls LT, Holley R, Chai TC, Kraus SR, Zyczynski H, Smith B, Stoddard A; Urinary Incontinence Treatment Network. The cost of preoperative urodynamics: A secondary analysis of the ValUE trial. Neurourol Urodyn. 2016 Jan;35(1):81-4. doi: 10.1002/nau.22684. Epub 2014 Oct 18.
- UITN Public WebsiteLink provided by the sponsor.
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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.
Ann Gormley, MD study chair
Dartmouth-Hitchcock Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Office evaluation and UDS in people with Urinary Incontinence, run by Carelon Research at 10 sites 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 14 inclusion and 19 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 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos. (time frame: 12 Months). 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 NCT00803959, which also lists 3 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 6 Aug 2013.