Trigonal-sparing Versus Trigonal-involved Intravesical Botulinumtoxin A Injection in Refractory Idiopathic Detrusor Overactivity.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 80
- Primary Endpoint
- 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.
Study Overview
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.
Detailed Description
Overactive bladder (OAB) is a condition characterized by the presence of urinary urgency, typically joined by frequency and nocturia, with or without urgency urinary incontinence [UUI], in the absence of urinary tract infection (UTI) or other clear pathology.
Frequency is the most commonly reported symptom coming to 85% while 54% complained of urgency and 36% urgency incontinence.
OAB has usually resulted from detrusor over activities. The basic cause could be a neurological disorder (neurogenic type) such as spinal cord injuries, multiple sclerosis. In some cases, no obvious cause could be identified (idiopathic type).
OAB is a prevalent, chronic symptom complex that can impair quality of life (QOL). The prevalence of OAB in the general population was evaluated at 11.8% in a population-based survey conducted across five European countries. Epidemiological studies from North America have reported prevalence of OAB in women of 16.9% and the prevalence increases with age rising to 30.9% in those beyond 65 years.
Treatment objectives are to reduce the occurrence of bothersome symptoms. Several treatment choices are available for OAB including bladder and behavioral training, pharmacologic treatment, and surgical treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with idiopathic OAB refractory to treatment with antimuscarinics for 2 months or intolerable side effects of antimuscrinics
Exclusion Criteria
- •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.
Arms & Interventions
trigonal sparing botox injection
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 .
Intervention: botulinum toxin A (Drug)
trigonal involved
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 .
Intervention: botulinum toxin A (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 3 months
Over active bladder symptoms score (OABSS).
Secondary Outcomes
- Arabic validation of overactive bladder symptoms score(3 months)
- 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)
Investigators
Mohamed Abdelbaset
principal investigator
Mansoura University