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Comparison of the efficacy of traditional method and modified technique for Botulinum injection in overactive bladder

Comparison of urodynamic results of Minimistic intra-detrusor Botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active bladder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210214050354N1
Enrollment
78
Registered
2022-06-26
Start date
2021-02-19
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Idiopathic overactive bladder. disease of the genitourinary system

Interventions

Intervention 1: Control group: As traditional method , spinal or general anesthesia is used. Patients will be hospitalized at least for one day after procedure . In each injection, 0.5 cc Botox are ap

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Idiopathic overactive bladders resistant to anticholinergic drugs taking at least four weeks. Anticholinergic medication intolerance due to side effects Anticholinergic contraindications

Exclusion criteria

Exclusion criteria: Neurogenic bladder due to CVA , Multiple sclerosis, Spinal cord injury , head trauma , Parkinson , disc herniations . Severe bladder outlet obstruction Recurrent UTI Urinary tract anomalies Previous bladder surgery History of pelvic radiation History of pelvic malignancies Pregnancy Age < 18 years old Male

Design outcomes

Primary

MeasureTime frame
Comparison of urodynamic results of Minimistic intra-detrusor botulinum injection and traditional technique during bladder storage phase in patients with idiopathic over active bladder. Timepoint: Urodynamic study before Botulinum injection and after 4-6 weeks post injection. Method of measurement: Urodynamic study.

Secondary

MeasureTime frame
Assessing the mean of maximum detrusor pressure in filling phase in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of maximum detrusor pressure in filling phase in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Comparison of the mean of maximum detrusor pressure in filling phase in both Minimistic and traditional methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of each detrusor over-activity duration in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of each detrusor over-activity duration in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Comparison of the mean of each detrusor over-activity duration in both Minimistic and traditional methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of bladder capacity in beginning of each detrusor over-activity in traditional method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of bladder capacity in beginning of each detrusor over-activity in Minimistic method. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Comparison of the mean of bladder capacity in beginning of each detrusor over-activity in both traditional and Minimistic methods. Timepoint: Before intervention and 4-6 weeks after Botox injection. Method of measurement: Urodynamic study.;Assessing the mean of functional bladder capacity in traditional method. Timepoint: Before intervention an

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Emami

Iran University of Medical Sciences

emami59658@yahoo.com+98 21 8116 1532

Outcome results

None listed

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