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Botulinum toxin injection in pediatric population with spastic neuropathic bladder

Botulinum toxin injection in pediatric population affected by spastic neuropathic bladder resistant to medical therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181124041743N1
Enrollment
20
Registered
2019-02-12
Start date
2018-11-30
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Condition 1: Neurogenic bladder. Condition 2: Neurogenic bladder dysfunction due to cauda equina syndrom. Neuromuscular dysfunction of bladder, unspecified Other specified diseases of spinal cord

Interventions

Intervention group: Patients who have the inclusion criteria to enrol the study,first will undergo primary urodynamic study with DELPHIS IP,MODEL 94_RO1P_BT manufactured by LABORIE MEDICAL TECHNOLOGIE

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Patients under the age of 18 Affected with Spastic Neurogenic Bladder Refer to Mofid Children's Hospital Under treatment with Clean Intermittent Catheterization Under treatment with maximal medical therapy with anti-cholinergic drugs Reveal anti-cholinergic drugs related complications Reveal anti-cholinergic drugs resistance

Exclusion criteria

Exclusion criteria: Patients who have been undergone prior bladder augmentation surgery Patients that their parents or their legal guardian don't accept their study enrollment

Design outcomes

Primary

MeasureTime frame
Bladder capacity after injection. Timepoint: Before intervention and 3 months after that. Method of measurement: Mofid children Hospital urodynamic measurement device ,model DELPHIS IP, MODEL: 94_RO1P_BT;Manufactured by LABORIE MEDICAL TECHNOLOGIES.;Hours of not demanding diaper change. Timepoint: Before and 3 months after Botox injection. Method of measurement: Interview with parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaran Lotfollahzadeh

Shahid Beheshti University of Medical Sciences

S.lotfollahzadeh@gmail.com+98 21 2222 7021

Outcome results

None listed

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