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Reducing the number and site of botulinum toxin injections in overactive bladder

Effectiveness of reducing the number and location of intra-detrusor Botulinum toxin injections in improving the symptoms of women with idiopathic overactive bladder: A double blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240504061648N3
Enrollment
100
Registered
2025-11-04
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder. N32.8

Interventions

Intervention 1: Intervention group: Intervention group: Injection of 100 units of botulinum toxin diluted with 5 cc of 0.9% normal saline into the bladder at 3 points on the posterior wall and trigone

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Overactive bladder syndrome or urge urinary incontinence Idiopathic decreased bladder compliance refractory to treatment with two or more anticholinergics

Exclusion criteria

Exclusion criteria: Previous history of botulinum toxin injection in any area of ??the body within the past 3 months Anterior, apical, and posterior compartment prolapse grade two or higher on vaginal examination based on POPQ Cognitive impairment Stress urinary incontinence, over flow, true, mixed sabagheh jarahi akhir sistam edrari dar 3_ mah gozashteh44 / 5,000History of recent urinary system surgery within the past 3 months Urinary voiding phase disorders and residual urine above 100 cc Voiding phase disorders in urodynamic study (Qmax less than 15 and pdet @Qmax less than 20 in women) Very small bladder volume below 150cc on ultrasound or VCUG

Design outcomes

Primary

MeasureTime frame
Urinary incontinence. Timepoint: Baseline, 4, and 12 weeks after intervention. Method of measurement: ICIQ-OAB questionnaire,.;Urinary frequency. Timepoint: Baseline, 4, and 12 weeks after intervention. Method of measurement: ICIQ-OAB questionnaire.

Secondary

MeasureTime frame
Nocturia. Timepoint: Baseline, 4, and 12 weeks after intervention. Method of measurement: ICIQ-OAB questionnaire.;Urgency. Timepoint: Baseline, 4, and 12 weeks after intervention. Method of measurement: ICIQ-OAB questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSakineh Hajebrahimi

Tabriz University of Medical Sciences

poormehrh@yahoo.com+98 51 6661 4756

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026