NCT03533062

Brief Summary

The investigators attend to conduct a prospective randomized study to assess safety and efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life measurement and post-injection anticholinergics use efficacy. Assessing safety by identification of side effects like constipation, urine retention....etc. efficacy is measured using Over Active Bladder Symptoms Score(OABSS) and urodynamics measures after 6 months follow up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

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

June 14, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

April 29, 2018

Last Update Submit

October 5, 2018

Conditions

Urologic DiseasesOveractive Bladder SyndromeQuality of LifeAnticholinergic Syndrome

Keywords

OAB , Botox , anticholinergics , quality of life

Outcome Measures

Primary Outcomes (1)

  • efficacy of Botox injections of the bladder treating OAB using Over active bladder Symptoms score (OABSS).OABSS total score is 15.more score means more symptoms.it is divided into:1-5 &6-10&11-15 means mild &moderate&sever symptoms respectively.

    Over active bladder symptoms score (OABSS).

    3 months

Secondary Outcomes (3)

  • efficacy of anticholinergics post botox injection using Over active bladder symptoms score (OABSS).

    3 months

  • quality of life assessment of patients with anticholinergics alone vs patients with botox injections vs combined therapy.

    3 months

  • Arabic validation of overactive bladder symptoms score

    3 months

Study Arms (2)

trigonal sparing botox injection

ACTIVE COMPARATOR

Using a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area excluding trigone in other arm Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).•then after 6 months postoperative anticholinergics administration .

Drug: botulinum toxin A

trigonal involved

ACTIVE COMPARATOR

Using a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area including the trigone .Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).then after 6 months postoperative anticholinergics administration .

Drug: botulinum toxin A

Interventions

botulinum toxin ADRUG

botox A injection trigonal or trigonal sparing with trial of anticholinergics 6 months post operative for 3 months

Also known as: anticholinergics
trigonal involvedtrigonal sparing botox injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with idiopathic OAB refractory to treatment with antimuscarinics for 2 months or intolerable side effects of antimuscrinics

You may not qualify if:

  • Patients who have any of the following were excluded:
  • Age less than 18 year old.
  • Neurogenic detrusor overactivity.
  • Evidence of obstructed flow in absence of prolapse.
  • Mixed urinary incontinence
  • Associated urethral pathology, e.g. Urethral diverticulum
  • Associated bladder pathology e.g. Fistula.
  • Active urinary tract infection as evidenced by positive urine culture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elbaset MA, Hashem A, Taha DE, Zahran MH, El-Hefnawy AS. Validation of the Arabic linguistic version of the Overactive Bladder Symptoms Score questionnaire. Arab J Urol. 2019 Jun 12;17(4):265-269. doi: 10.1080/2090598X.2019.1627061. eCollection 2019.

    PMID: 31723443DERIVED

MeSH Terms

Conditions

Urologic DiseasesAnticholinergic Syndrome

Interventions

Botulinum Toxins, Type ACholinergic Antagonists

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Ahmed Shoma, MD

    Urology and Nephrology Cente. Mansourah, Aldakahlia, Egypt, 35516

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 29, 2018

First Posted

May 22, 2018

Study Start

June 14, 2015

Primary Completion

October 30, 2016

Study Completion

May 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10