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Completed

NCT Number: NCT04124939

Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

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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 Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Urology clinic locations at Wake Forest Baptist Medical Center, Greensboro, North Carolina, United States

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About this study

This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female gender
  • At least 18 years of age
  • Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
  • Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
  • Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
  • Able to give informed consent

Exclusion criteria

  • Male gender
  • Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
  • Acute urinary tract infection
  • Treatment with Botox® toxin for other conditions
  • Allergy to Botox® toxin
  • Hematuria that has not been worked up
  • Known bladder malignancy
  • Previous history of bladder augmentation
  • Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
  • Currently taking aminoglycoside antibiotics
  • Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
  • History of chronic pain or pain syndromes

Treatment and study plan

OnabotulinumtoxinA 100 Units

Drug

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

  • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Other names: BOTOX

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Post Procedure Day 1

    The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.

Secondary outcomes

  1. Difference in Mean Urge Incontinence Episodes

    Time frame: Week 12 after procedure

    The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure

  2. Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

    Time frame: Baseline

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

  3. Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

    Time frame: 2 weeks post procedure

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

  4. Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

    Time frame: 12 weeks post procedure

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

  5. Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life

    Time frame: Baseline

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  6. Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life

    Time frame: 2 weeks post procedure

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  7. Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life

    Time frame: 12 weeks post procedure

    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  8. Post-Void Residual (PVR)

    Time frame: 2 weeks post procedure

    PVR using bladder scanner evaluates the post void residual in the bladder.

  9. Post-Void Residual (PVR)

    Time frame: 12 weeks post procedure

    PVR using bladder scanner evaluates the post void residual in the bladder.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 14, 2019
Registry last updated
Apr 17, 2024

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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