A comparative study between treatment with oxybutynin and botulinum toxin type A in patients with neurogenic detrusor overactivity

A comparative study between oxybutynin and botulinum toxin type A in patients with neurogenic detrusor overactivity: urodynamic response and impact of treatment on quality of life: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56769820

Enrollment

Registered

2011-06-13

Start date

2010-04-01

Completion date

Unknown

Last updated

2017-07-24

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

Conditions

Spinal cord injury/detrusor overactivity Urological and Genital Diseases Other specified disorders of bladder

Interventions

1. Group 1 (n=40) will receive 15 mg oxybutynin orally three times daily 2. Group 2 (n=28) will be treated with intradetrusor injections of 300 U BoNTA (Botox)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients 2. Over 18 years of age 3. Patients who have had an SCI for at least 12 months 4. Patients who have been regularly undergoing intermittent catheterisation

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. A desire to become pregnant during the study period 3. Breastfeeding 4. The use of anticoagulants or a report of a blood coagulation disorder 5. Neuromuscular transmission disorder 6. The use of any intravesical pharmacologic agents 7. Previous use of BoNTA

Design outcomes

Secondary

Measure	Time frame
1. Evaluation of quality of life 2. Systemic side-effects	—

Primary

Measure	Time frame
Evaluation of urodynamic parameters: 1. Maximum cystometric capacity (MCC) 2. Maximum detrusor pressure (Pdetmax) 3. Bladder compliance	—

Countries

Brazil

Outcome results

None listed

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