Clinical Trials Logo
  1. Home
  2. Urinary Incontinence
  3. NCT03801239
  4. Details
NCT03801239 Clinical Trial

Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)

Urinary Incontinence Clinical Trial

Official title:
Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS) Questionnaire and the Correlation of OABSS With the Results of UDI-6 and IIQ-7 Questionnaires

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03801239
Other study ID # 01/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date December 31, 2018

Study information
Verified date January 2019
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to develop and assess the effectiveness of a Polish version of OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7 questionnaires

Description:

The translation into Polish followed standardized procedures. Women aged between 18-75 years were included into the study. All patients were recruited from women attending the Outpatient Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases; OAB in 283 patients and 249 had MUI (confirmed by medical history, and urodynamic investigation). All patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.

Recruitment information / eligibility
Status Completed
Enrollment 822
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)

- female aged 18-75 years old

Exclusion Criteria:

- malignant disorders

- uncontrolled diabetes

- inability to understand informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urodynamic Study
during visit Week 0 patients had urodynamic study
• OABSS questionnaire fulfilment
during visit Week 0 and Week 2 patients fulfilled OABSS
• UDI-6 questionnaire fulfilment
during visit Week 2 patients fulfilled UDI-6 questionnaire
• IIQ-7 questionnaire fulfilment
during visit Week 2 patients fulfilled IIQ-7 questionnaire

Locations
Country Name City State
Poland Medical University of Lublin Lublin Lubelskie

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of OABSS questionnaire and Urodynamic study Results of polish version of OABSS are correlated with Urodynamic study results 2 weeks
Secondary Correlation of OABSS questionnaire with UDI-6 results Results of polish version of OABSS are correlated with UDI-6 results 2 weeks
Secondary Correlation of OABSS questionnaire with IIQ-7 results Results of polish version of OABSS are correlated with IIQ-7 results 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3