Over Active Bladder Instillation Study - Botox | NCT00667095

NCT00667095

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botox and DMSO instillation	Experimental	Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution	Drug: Botox Instillation Drug: DMSO Instillation
DMSO instillation	Placebo Comparator	Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters	Drug: DMSO Instillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botox Instillation	Drug	Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.	Botox and DMSO instillation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)	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.	baseline, 1 month, 3 months

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Steven P Petrou, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32224	United States

PubMed Identifier	Type	Citation	Retractions
19648387	Background	Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.

Arm/Group Information

ID	Title	Description
FG000	Botox and DMSO Instillation	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.
FG001	DMSO Instillation	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Botox and DMSO Instillation	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Incontinence Quality of Life (I-QoL) Score

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.

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).

Posted

Mean

Standard Deviation

units on a scale

Baseline, 1 month, 3 months

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Botox and DMSO Instillation	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hospitalization for body jerking and termons due to oligodendroglioma.	Nervous system disorders		Systematic Assessment

ID	Term
D053201	Urinary Bladder, Overactive
D053202	Urinary Incontinence, Urge
D014549	Urinary Incontinence

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

OG000	Botox and DMSO Instillation	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.
OG001	DMSO Instillation	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.