Botulin-A Toxin Instillations and Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00583219
First received: December 20, 2007
Last updated: March 14, 2014
Last verified: March 2014
Results First Received: March 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Overactive Bladder
Detrusor Instability
Detrusor Hyperreflexia
Interventions: Drug: Botulinum-A toxin
Drug: Dimethyl sulfoxide (DMSO)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from November 2006 to March 2009 at Mayo Clinic in Jacksonville, Florida.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Botox/DMSO Solution

Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.

All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.

Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.

Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.


Participant Flow for 2 periods

Period 1:   Phase 1
    Botox/DMSO Solution  
STARTED     9 [1]
COMPLETED     9  
NOT COMPLETED     0  
[1] First 3 subjects in Phase 1 received 200 units Botox. The remaining subjects got 300 units Botox.

Period 2:   Phase 2
    Botox/DMSO Solution  
STARTED     22 [1]
COMPLETED     21  
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 6 subjects from P1 continued in P2; plus 16 new subjects. All subjects in P2 got 300 units Botox.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Botox/DMSO Solution

Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.

The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.

Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.

Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.


Baseline Measures
    Botox/DMSO Solution  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Median ( Full Range )
  74  
  ( 37 to 86 )  
Gender  
[units: participants]
 
Female     25  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     25  
Body Mass Index  
[units: kg/m^2]
Median ( Full Range )
  26.6  
  ( 18.4 to 40.0 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Number of Incontinent Episodes During 24 Hours   [ Time Frame: baseline, 1 month, 3 months ]

2.  Secondary:   Median 24 Hour Pad Weight   [ Time Frame: baseline, 1 month, 3 months ]

3.  Secondary:   Blaivas-Groutz Anti-Incontinence Score at Baseline   [ Time Frame: baseline ]

4.  Secondary:   Blaivas-Groutz Anti-Incontinence Score at 1 Month   [ Time Frame: 1 month after treatment ]

5.  Secondary:   Blaivas-Groutz Anti-Incontinence Score at 3 Months   [ Time Frame: 3 months after treatment ]

6.  Secondary:   Mean Number of Pads Per Day   [ Time Frame: baseline, 1 month, 3 months ]

7.  Secondary:   Postvoid Residual   [ Time Frame: baseline, 1 month, 3 months ]

8.  Secondary:   Urine Culture   [ Time Frame: baseline, 1 month, 3 months ]

9.  Secondary:   Urinary Urgency at Baseline   [ Time Frame: baseline ]

10.  Secondary:   Urinary Urgency at 1 Month   [ Time Frame: 1 month after treatment ]

11.  Secondary:   Urinary Urgency at 3 Months   [ Time Frame: 3 months after treatment ]

12.  Secondary:   Median Urogenital Distress Inventory (UDI-6) Scores   [ Time Frame: baseline, 1 month, 3 months ]

13.  Secondary:   Bothersomeness   [ Time Frame: baseline, 1 month, 3 months ]

14.  Secondary:   Incontinence Impact Questionnaire-short Form (IIQ-7) Scores   [ Time Frame: baseline, 1 month, 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Steven P. Petrou
Organization: Mayo Clinic
phone: 904-953-7330
e-mail: petrou.steven@mayo.edu


Publications of Results:

Responsible Party: Dr. Steven Petrou, Mayo Clinic Jacksonville
ClinicalTrials.gov Identifier: NCT00583219     History of Changes
Other Study ID Numbers: 359-06
Study First Received: December 20, 2007
Results First Received: March 14, 2014
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board