Trigonal vs Non Trigonal Botox Injection in OAB.

NCT03533062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

  • Urologic Diseases
  • Overactive Bladder Syndrome
  • Quality of Life
  • Anticholinergic Syndrome

Interventions

DRUG

botulinum toxin A

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed Shoma, MD · Urology and Nephrology Cente. Mansourah, Aldakahlia, Egypt, 35516

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-14
Primary Completion
2016-10-30
Completion
2018-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533062 on ClinicalTrials.gov