NCT04309890

Brief Summary

The English version of the Overactive Bladder Symptom Score (OABSS) questionnaire was translated to Arabic language. The questionnaire was validated by comparing the response to the questionnaire in a patient with Overactive Bladder (OAB) before and after providing treatment with antimuscarinics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 13, 2020

Last Update Submit

March 13, 2020

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • development and validation of Arabic version of the Overactive Bladder Symptom Score (OABSS) questionnaire

    3 months

Study Arms (1)

Study group

Other: Arabic version of the Overactive Bladder Symptom Score Questionnaire

Interventions

Arabic version of the Overactive Bladder Symptom Score QuestionnaireOTHER

All enrolled patients were asked to complete the Arabic OABSS questionnaire in its final edition before and three months after treatment with Solfinasin 5 mg once daily

Study group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study has included 235 patients, 152 (62.9%) females and 83 (37.1%) males.

You may qualify if:

  • More than 20 years
  • Had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia).

You may not qualify if:

  • Active urinary tract infection.
  • Predominant symptoms of urinary stress incontinence;
  • Diabetes mellitus;
  • Previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery;
  • Previous neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mu'tah University

Karak, Jordan

Location

Related Publications (1)

  • Sawaqed F, Suoub M. Validating 7-items Overactive Bladder Symptom Score (OABSS) through Arabic linguistic version. Sci Rep. 2021 Jan 12;11(1):661. doi: 10.1038/s41598-020-79974-9.

    PMID: 33436744DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 16, 2020

Study Start

February 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

JO(1)