Patient Satisfaction Survey of Non-surgical Urinary Incontinence Treatment

Urinary Incontinence Clinical Trial

Official title:

Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064970
• Other study ID #: RSRB72759
• Status: Completed
• Start date: March 14, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	University Urogynecology Associates	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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).	baseline to 6 weeks
Secondary	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.	6 weeks
Secondary	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).	baseline to 6 weeks
Secondary	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.	6 weeks