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Completed

NCT Number: NCT02735499

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

Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Dept of Ob/Gyn, The Hospital of Vestfold

Tønsberg, N-3103, Norway

About this study

Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.

15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onabotulinum toxin A

Drug

Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes

Other names: Botox

Primary outcomes

  1. Change in number of leakage episodes

    Time frame: 24 hours

    Measured with a 24-hour voiding chart

Secondary outcomes

  1. Change in grams leakage

    Time frame: 24 hours

    Measured with a 24-hour voiding chart

  2. Change in number of voids

    Time frame: 24 hours

    Measured with a 24-hour voiding chart

  3. Change in mean voided volume

    Time frame: 24 hours

    Measured with a 24-hour voiding chart

  4. Change in Urinary Distress Inventory-6 score (UDI-6)

    Time frame: 6 months

    Questionnaire

  5. Change in Incontinence Impact Questionnaire-7 score (IIQ-7)

    Time frame: 6 months

    Questionnaire

  6. Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)

    Time frame: 6 months

    Questionnaire

  7. Change in flow rate

    Time frame: 4 weeks

    Measured by flowmetry

Sponsors and collaborators

Lead sponsor

The Hospital of Vestfold

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Bladder Instillation of Botox With EMDA for OAB - a Pilot Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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