NCT06408051

Brief Summary

This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

May 6, 2024

Last Update Submit

December 21, 2024

Conditions

Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment

Outcome Measures

Primary Outcomes (2)

  • frequencies of urination, nocturia, incontinence episodes

    below 8,above 8

    1 years

  • urgency,

    present or absent

    1 years

Study Arms (1)

singel

Procedure: Injection of onabotulinumtoxinA into the bladder wall

Interventions

Injection of onabotulinumtoxinA into the bladder wallPROCEDURE

BTX was injected into the detrusor muscles at 20 sites

singel

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In patients with overactive bladder and urinary incontinence who had previously failed to respond to anticholinergic treatments

You may qualify if:

  • overactive bladder urge incontinence

You may not qualify if:

  • neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basri Cakiroglu

Istanbul, 34768, Turkey (Türkiye)

Location

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

January 1, 2020

Primary Completion

January 31, 2022

Study Completion

July 31, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

TU(2)