Urinary IncontinenceNCT04064970
Patient Satisfaction Survey of Non-surgical Urinary Incontinence Treatment
An observational study of Urinary Incontinence, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- patient acceptable symptom state (PASS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 1 Jul 2020
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects will be women over the age of 18 who desire nonsurgical management of stress urinary incontinence.
Who may be able to join
- Adult women (> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
- English-speaking
- Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries
Who cannot join
- Women who decline to participate in the study
- Women were unable to complete electronic patient reported outcome questionnaires
- Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
- Women considered citizens of the European Union (EU), including EU citizens living in the United States.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Urogynecology Associates
Rochester, New York, 14623
About this study
Official title: Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence
The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.
- Conditions
- Urinary Incontinence
- Being tested
- patient acceptable symptom state (PASS)
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient acceptable symptom state (PASS)Behavioural
The Severity Index for Urinary Incontinence, which documents incontinence frequency and severity, pelvic floor distress, patient global impression of severity and improvement, physical function, depression, sleep disturbance, anxiety, global health and ability to participate in social roles and activities.
| Study group | Role | What they receive |
|---|---|---|
| PASS Cohort | Not described Receives: Behavioral: patient acceptable symptom state (PASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer
Each participant will be asked to complete the Urinary Distress Inventory 6 (UDI-6) after enrollment and again after 6 weeks. This is a short validated disease-specific patient reported outcome measuring urinary incontinence severity. The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life. The question "Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?" and provide a yes/no answer. Statistical analysis will then be performed to determine the threshold score at which one is likely to consider their symptoms to be acceptable, PASS "yes". Participants whose UDI score matches their PASS answer will be considered predicted and counted for this outcome measure.
Measured: 6 weeks
Secondary outcomes (4)
Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the anchor-based method of analysis
The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100 with a questions specifically related to stress urinary incontinence. The higher the score the greater perceived negative impact on an individual's quality of life The MID represents a clinically significant improvement in self-reported symptomatology. Anchor-based methods assess responsiveness in relation to an external event or rating to quantify the meaning of the particular degree of change. This is traditionally assessed by a moderate relationship noted using correlations between the negative score change and the external anchor. Participants will complete the UDI-6 at baseline and after 6 weeks. The MID will be defined by the mean score change reported by women who indicate improvement on the Patient Global Impression of severity (PGI-S) and Improvement (PGI-I).
Measured: baseline to 6 weeks
Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the distribution-bases method of analysis
The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100 with a questions specifically related to stress urinary incontinence. The higher the score the greater perceived negative impact on an individual's quality of life The MID represents a clinically significant improvement in self-reported symptomatology. Distribution-based methods rely on the distribution of scores within a population and relate clinical significance to a change in magnitude at least equal to a statistical parameter of group data such as standard deviation (SD). This is traditionally assessed by including the effect size and standard error of measurement (SEM). A medium effect (0.5 SD) and a small effect size (0.2SD). The MID is estimated as 1 SEM.
Measured: 6 weeks
Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the anchor-based method of analysis
The UIQ-7 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life. The MID represents a clinically significant improvement in self-reported symptomatology. Anchor-based methods assess responsiveness in relation to an external event or rating to quantify the meaning of the particular degree of change. This is traditionally assessed by a moderate relationship noted using correlations between the negative score change and the external anchor. Participants will complete the UDI-6 at baseline and after 6 weeks. The MID will defined by the mean score change reported by women who indicate improvement on the Patient Global Impression of severity (PGI-S) and Improvement (PGI-I).
Measured: baseline to 6 weeks
Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the distribution-bases method of analysis
The UIQ-7 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life The MID represents a clinically significant improvement in self-reported symptomatology. Distribution-based methods rely on the distribution of scores within a population and relate clinical significance to a change in magnitude at least equal to a statistical parameter of group data such as standard deviation (SD). This is traditionally assessed by including the effect size and standard error of measurement (SEM). A medium effect (0.5 SD) and a small effect size (0.2SD). The MID is estimated as 1 SEM.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start14 Mar 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Duecy, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064970
- Sponsor's protocol ID
- RSRB72759
- Status last verified
- Oct 2020
- First submitted
- 14 Feb 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04064970
- Acronym / sponsor ID
- RSRB72759
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 22 Aug 2019 (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 identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PASS Cohort | – | Behavioral: patient acceptable symptom state (PASS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will be women over the age of 18 who desire nonsurgical management of stress urinary incontinence.
Key inclusion criteria (3 listed)
- Adult women (> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
- English-speaking
- Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries
Key exclusion criteria (4 listed)
- Women who decline to participate in the study
- Women were unable to complete electronic patient reported outcome questionnaires
- Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
- Women considered citizens of the European Union (EU), including EU citizens living in the United States.
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 |
|---|---|---|
| patient acceptable symptom state (PASS)The Severity Index for Urinary Incontinence, which documents incontinence frequency and severity, pelvic floor distress, patient global impression of severity and improvement, physical function, depression, sleep disturbance, anxiety, global health and ability to participate in social roles and activities. | Behavioural | PASS Cohort |
Primary outcome
number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer
Time frame: 6 weeks
Each participant will be asked to complete the Urinary Distress Inventory 6 (UDI-6) after enrollment and again after 6 weeks. This is a short validated disease-specific patient reported outcome measuring urinary incontinence severity. The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life. The question "Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?" and provide a yes/no answer. Statistical analysis will then be performed to determine the threshold score at which one is likely to consider their symptoms to be acceptable, PASS "yes". Participants whose UDI score matches their PASS answer will be considered predicted and counted for this outcome measure.
4 secondary outcomes
Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the anchor-based method of analysis
Time frame: baseline to 6 weeks
Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the distribution-bases method of analysis
Time frame: 6 weeks
Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the anchor-based method of analysis
Time frame: baseline to 6 weeks
Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the distribution-bases method of analysis
Time frame: 6 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 6 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by University of Rochester 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 3 inclusion and 4 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 Oct 2020. 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?
number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer (time frame: 6 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 6 Oct 2020.