Clincosm LogoSign in Get a demo

Over Active Bladder Instillation Study - Botox

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT00667095
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
45
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Botox Instillation
  • Drug: DMSO Instillation
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Incontinence Quality of Life (I-QoL) Score [Baseline, 1 month, 3 months]

      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

    1. Change in Incontinence Impact Questionnaire Short Form (IIQ-7) [baseline, 1 month, 3 months]

      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.

    2. Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) [baseline, 1 month, 3 months]

      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.

    3. Change in Urogenital Distress Inventory (UDI-6) [baseline, 1 month, 3 months]

      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.

    4. Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months [baseline, 1 month, 3 months]

      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).

    5. Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months [Baseline, 1 month, 3 months]

      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."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Steven P Petrou, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00667095
    Other Study ID Numbers:
    • 07-007399
    First Posted:
    Apr 25, 2008
    Last Update Posted:
    Jul 11, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by , ,
    OAB
    Over Active Bladder
    overactive bladder
    Urinary Urge Incontinence
    Urinary Incontinence
    Botox
    DMSO
    bladder instillation
    instillation
    detrusor hyperreflexia
    urge incontinence
    Additional relevant MeSH terms:
    Reflex, Abnormal
    Urinary Incontinence
    Enuresis
    Urinary Bladder, Overactive
    Urinary Incontinence, Urge
    Botulinum Toxins, Type A
    Dimethyl Sulfoxide

    Study Results

    Participant Flow

    Recruitment Details A total of 25 subjects were recruited from 10/21/2008 to 8/19/2010. Three of these were determined to be screen failures before randomization, and another one was withdrawn prior to randomization. Twenty one subjects were randomized: 11 to Botox/DMSO, and 10 to DMSO only.
    Pre-assignment Detail
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Period Title: Overall Study
    STARTED 11 10
    COMPLETED 11 9
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Botox and DMSO Instillation DMSO Instillation Total
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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. Total of all reporting groups
    Overall Participants 11 10 21
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    58
    71
    68
    Sex: Female, Male (Count of Participants)
    Female
    11
    100%
    10
    100%
    21
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    11
    100%
    10
    100%
    21
    100%
    Smoking Status (participants) [Number]
    Never smoked
    4
    36.4%
    6
    60%
    10
    47.6%
    Past smoker
    6
    54.5%
    4
    40%
    10
    47.6%
    Current smoker
    1
    9.1%
    0
    0%
    1
    4.8%
    History of Hypertension (participants) [Number]
    Hypertension
    6
    54.5%
    7
    70%
    13
    61.9%
    No hypertension
    5
    45.5%
    3
    30%
    8
    38.1%
    History of Urinary Tract Infections (UTIs) (participants) [Number]
    Previous history of UTIs
    10
    90.9%
    10
    100%
    20
    95.2%
    No previous UTIs
    1
    9.1%
    0
    0%
    1
    4.8%
    Number of Vaginal Births (participants) [Number]
    0 vaginal births
    3
    27.3%
    3
    30%
    6
    28.6%
    1-2 vaginal births
    4
    36.4%
    1
    10%
    5
    23.8%
    ≥ 3 vaginal births
    4
    36.4%
    6
    60%
    10
    47.6%
    Body Mass Index (kg/m^2) [Median (Full Range) ]
    Median (Full Range) [kg/m^2]
    26
    30
    27
    Post-Void Residual Urine (mL) [Median (Full Range) ]
    Median (Full Range) [mL]
    15
    29
    17
    Incontinent Episodes during 24 Hours (Episodes) [Median (Full Range) ]
    Median (Full Range) [Episodes]
    6
    3
    4
    Median 24 Hour Pad Weight (g) [Median (Full Range) ]
    Median (Full Range) [g]
    166
    179
    166
    Median Number of Pads Per Day (pads) [Median (Full Range) ]
    Median (Full Range) [pads]
    4
    5
    5

    Outcome Measures

    1. Primary Outcome
    Title Change in Incontinence Quality of Life (I-QoL) Score
    Description 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.
    Time Frame Baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    Change from baseline to 1 month
    9.6
    (13.3)
    -3.9
    (11.6)
    Change from baseline to 3 months (n=11, 9)
    8.6
    (14.4)
    -4.0
    (9.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 1 month.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.024
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 3 months.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.036
    Comments
    Method t-test, 2 sided
    Comments
    2. Secondary Outcome
    Title Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
    Description 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.
    Time Frame baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    Change from baseline to 1 month
    -2.5
    (4.0)
    2.0
    (5.9)
    Change from baseline to 3 months (n=11, 9)
    -1.8
    (4.2)
    1.1
    (3.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 1 month.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 3 months.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
    Description 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.
    Time Frame baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    Change from baseline to 1 month
    -2.4
    (5.8)
    -0.5
    (4.4)
    Change from baseline to 3 months (n=11, 9)
    -2.5
    (5.1)
    0.8
    (4.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 1 month.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.42
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 3 months.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments
    Method t-test, 2 sided
    Comments
    4. Secondary Outcome
    Title Change in Urogenital Distress Inventory (UDI-6)
    Description 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.
    Time Frame baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    Change from baseline to 1 month
    -1.9
    (3.7)
    -0.1
    (1.9)
    Change from baseline to 3 months (n=11, 9)
    -0.9
    (3.6)
    -0.4
    (3.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 1 month
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 3 months.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.77
    Comments
    Method t-test, 2 sided
    Comments
    5. Secondary Outcome
    Title Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months
    Description 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).
    Time Frame baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    1 month
    6
    54.5%
    4
    40%
    3 months (n=11, 9)
    6
    54.5%
    2
    20%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to one month
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.67
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change from baseline to 3 months.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments
    Method t-test, 2 sided
    Comments
    6. Secondary Outcome
    Title Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months
    Description 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."
    Time Frame Baseline, 1 month, 3 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    Measure Participants 11 10
    1 month
    4
    36.4%
    1
    10%
    3 months (n=11, 9)
    5
    45.5%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change between baseline and one month
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Botox and DMSO Instillation, DMSO Instillation
    Comments Change between baseline and 3 months
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.038
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Botox and DMSO Instillation DMSO Instillation
    Arm/Group Description Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. 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. Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters 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.
    All Cause Mortality
    Botox and DMSO Instillation DMSO Instillation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Botox and DMSO Instillation DMSO Instillation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 2/10 (20%)
    Infections and infestations
    Hospitalization for joint pain due to infection 0/11 (0%) 0 1/10 (10%) 1
    Hospitalization for tibial ulcer 0/11 (0%) 0 1/10 (10%) 1
    Nervous system disorders
    Hospitalization for body jerking and termons due to oligodendroglioma. 0/11 (0%) 0 1/10 (10%) 1
    Other (Not Including Serious) Adverse Events
    Botox and DMSO Instillation DMSO Instillation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/11 (54.5%) 7/10 (70%)
    Blood and lymphatic system disorders
    Swollen ankles 0/11 (0%) 0 1/10 (10%) 1
    Nose Bleed 0/11 (0%) 0 1/10 (10%) 1
    Cardiac disorders
    High Blood Pressue 1/11 (9.1%) 1 0/10 (0%) 0
    Infections and infestations
    Urinary Tract Infection 3/11 (27.3%) 4 5/10 (50%) 6
    Injury, poisoning and procedural complications
    Had fall, unable to walk 1/11 (9.1%) 1 0/10 (0%) 0
    Left Distal Radius Fracture from a Twist and Fall 0/11 (0%) 0 1/10 (10%) 1
    Renal and urinary disorders
    Bladder spasms after instillation 0/11 (0%) 0 1/10 (10%) 1
    Skin and subcutaneous tissue disorders
    Rash 1/11 (9.1%) 1 0/10 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Steven P. Petrou
    Organization Mayo Clinic
    Phone 904-953-7330
    Email peterou.steven@mayo.edu
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00667095
    Other Study ID Numbers:
    • 07-007399
    First Posted:
    Apr 25, 2008
    Last Update Posted:
    Jul 11, 2014
    Last Verified:
    Jul 1, 2014