Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02735499
• Date of registration: 06/04/2016
• Prospective Registration: No
• Primary sponsor: The Hospital of Vestfold
• Public title: Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)
• Scientific title: Bladder Instillation of Botox With EMDA for OAB - a Pilot Study
• Date of first enrolment: March 2016
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02735499
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Norway

Contacts

• Name: Hjalmar A Schiotz, MD, PhD
• Affiliation: Vestfold Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent form signed

- OAB/urgency incontinence of at least 3 months duration

- Conservative treatment (medicines, electrical stimulation) has been tried without
sufficient benefit

- There is indication for cystoscopic injection treatment with Botox®

- More than 3 months since any previous treatment with Botox®

- Detrusor overactivity documented by cystometry is desirable, but not obligatory

Exclusion Criteria:

- Age below 18 years

- Mixed incontinence with predominant stress component

- Insufficient understanding of Norwegian and / or unable to fill out the necessary
forms

- Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and
leucocytes) with symptoms of UTI) must be treated before inclusion.

- Any contraindication stated in the Summary of product characteristics (SPC) for Botox



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: onabotulinum toxin A

Primary Outcome(s)

Change in number of leakage episodes [Time Frame: 24 hours]

Secondary Outcome(s)

Change in flow rate [Time Frame: 4 weeks]

Change in number of voids [Time Frame: 24 hours]

Change in grams leakage [Time Frame: 24 hours]

Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF) [Time Frame: 6 months]

Change in mean voided volume [Time Frame: 24 hours]

Change in Incontinence Impact Questionnaire-7 score (IIQ-7) [Time Frame: 6 months]

Change in Urinary Distress Inventory-6 score (UDI-6) [Time Frame: 6 months]

Secondary ID(s)

Botox instillation study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

South-Eastern Norway Regional Health Authority