Over Active Bladder Instillation Study - Botox

This study has been terminated.
(Study terminated early due to PI's extended medical leave.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00667095
First received: April 23, 2008
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.


Condition Intervention Phase
Overactive Bladder
Urinary Urge Incontinence
Urinary Incontinence
Detrusor Hyperreflexia
Urge Incontinence
Drug: Botox Instillation
Drug: DMSO Instillation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Incontinence Quality of Life (I-QoL) Score [ Time Frame: Baseline, 1 month, 3 months ] [ Designated as safety issue: No ]

    The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'.

    A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.



Secondary Outcome Measures:
  • Change in Incontinence Impact Questionnaire Short Form (IIQ-7) [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life.

  • Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.

  • Change in Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life.

  • Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).

  • Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months [ Time Frame: Baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: "Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."


Enrollment: 25
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox and DMSO instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Drug: Botox Instillation
Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
Other Names:
  • Botulinum-A Toxin
  • Botox
Drug: DMSO Instillation
DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
Other Names:
  • Dimethyl Sulfoxide
  • DMSO
Placebo Comparator: DMSO instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
Drug: DMSO Instillation
DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
Other Names:
  • Dimethyl Sulfoxide
  • DMSO

Detailed Description:

The primary objective of this study is to evaluate the efficacy of catheter-based instillation of a solution of Botox/DMSO as a novel method for treating women with overactive bladder (OAB) and secondary urinary incontinence who have failed oral pharmacologic therapy. This study will test the broad hypothesis that administration of Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve symptoms and quality of life in patients with OAB when compared to DMSO installations alone. Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL) questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at three-month follow-up compared to similar women receiving DMSO instillation alone. Our long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholinergic by mouth medications. In support of this effort, we are proposing a randomized, double-blind, placebo controlled clinical trial to be conducted in the Department of Urology at Mayo Clinic, Jacksonville, Florida.

Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient aged 18 years or older
  • No evidence of stress urinary incontinence on physical examination or urodynamics
  • Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
  • Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
  • Patient who is mentally competent with the ability to understand and comply with the requirements of the study
  • Patient who agrees to be available for the follow-up evaluations as required by the protocol
  • Patient who has given signed informed consent

Exclusion Criteria:

  • Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
  • Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
  • Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
  • Patient with un-investigated hematuria
  • Patient with lower tract genitourinary malignancies
  • Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
  • Patient with ongoing complications of prior anti-incontinence surgery
  • Patient who is pregnant, lactating, or planning to become pregnant within the study period
  • Patient who has received pelvic radiation
  • Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
  • Patient who is morbidly obese (defined as BMI > 40 Kg/m2)
  • Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
  • Patient with current or acute urinary tract infection, including cystitis or urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)
  • Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
  • Patient on immunomodulatory therapy (suppressive or stimulatory)
  • Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure
  • Patient with a concurrent use of another study product within two weeks prior to study start, or who concurrently participate in any other clinical study
  • Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
  • Patient with a life expectancy of less than 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667095

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Steven P Petrou, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Steven P. Petrou, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00667095     History of Changes
Other Study ID Numbers: 07-007399
Study First Received: April 23, 2008
Results First Received: May 9, 2014
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
OAB
Over Active Bladder
overactive bladder
Urinary Urge Incontinence
Urinary Incontinence
Botox
DMSO
bladder instillation
instillation
detrusor hyperreflexia
urge incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Botulinum Toxins, Type A
Dimethyl Sulfoxide
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014