Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Satisfaction Survey of Non-surgical Urinary Incontinence Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064970
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Erin Duecy, University of Rochester

Brief 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.

Condition or disease Intervention/treatment
Urinary Incontinence Behavioral: patient acceptable symptom state (PASS)

Layout table for study information
Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PASS Cohort Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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.

  3. 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 ]
    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).

  4. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible subjects will be women over the age of 18 who desire nonsurgical management of stress urinary incontinence.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064970


Locations
Layout table for location information
United States, New York
University Urogynecology Associates
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
Layout table for additonal information
Responsible Party: Erin Duecy, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04064970    
Other Study ID Numbers: RSRB72759
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders