NCT03888001

Brief Summary

To assess the efficacy of botulinum toxin injection in overactive bladder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

March 18, 2019

Last Update Submit

March 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Botulinum Toxin injection in overactive Bladder

    By using of quistionaire mainly arabic validation of urogenital distress inventory ( UDI-6 quistionaire) throug appling quistions to patients that compare between symptoms before and after botox injection...

    1 year

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with either sex and above age of 6 years with diagnosis of idiopathic or neurogenic overactive bladder diagnosed clinically and urodynamically admitted to Assiut university hospital. Paitent with neurogenic lowcompliance or detrusor overactivity affecting bladder function

You may qualify if:

  • patients with spastic neurogenic bladder due to upper motor neuron lesion as (spinal cord lesions ,multiple sclerosis ,strokes,parkinsonism...........).
  • patients with idiopathic overactive bladder
  • patients with spastic neurogenic bladder diagnosed clinically and urodynamically.

You may not qualify if:

  • patients with diabetes mellitus.
  • Atonic bladder.
  • Children below 6 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Farahat

Asyut, Egypt

RECRUITING

Related Publications (1)

  • 1. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci 2008;9:453-66. 2. Aoki KR, Guyer B. Botulinum toxin type A and other botulinum toxin serotypes: a comparative review of biochemical and pharmacological actions. Eur J Neurol 2001;8 Suppl 5:21-9. 3. Tanagho EA, McAninch JW, editors. Smith's General Urology. 17th ed. New York: The McGraw-Hill Companies, Inc., 2008,438-53. 4. Sellers DJ, McKay N. Developments in the pharmacotherapy of the overactive bladder. Curr Opin Urol2007;17:223-30. 5-Aoki, K.R. Pharmacology and immunology of botulinum toxin serotypes. J. Neurol. 2001; 248: 3-10

    BACKGROUND

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 Officials

  • AHMED FARAHAT, MASTER

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED FARAHAT, MASTER

CONTACT

mahmoud FARAHAT, MASTER

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 25, 2019

Study Start

January 1, 2018

Primary Completion

April 1, 2019

Study Completion

March 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations