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Anticholinergic vs. Botox Comparison Study (ABC)

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ClinicalTrials.gov Identifier: NCT01166438
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
dwallace, NICHD Pelvic Floor Disorders Network

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Urge Urinary Incontinence
Overactive Bladder
Interventions: Drug: Botulinum toxin A (Botox A®)
Drug: Solifenacin 5mg
Drug: Solifenacin 10mg
Drug: Trospium chloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 A

A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets

Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.

Standardized Anticholinergic Regimen

A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.

Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months

Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon


Participant Flow for 2 periods

Period 1:   Double-blind Phase: 1st 6 Months
    Botox A   Standardized Anticholinergic Regimen
STARTED   122   127 
Treated   121   126 
COMPLETED   113 [1]   118 [1] 
NOT COMPLETED   9   9 
Withdrawal by Subject                8                4 
Lost to Follow-up                0                4 
Not treated                1                1 
[1] Completion of 12 month follow-up visit

Period 2:   Off Treatment Follow-up Phase
    Botox A   Standardized Anticholinergic Regimen
STARTED   85   89 
COMPLETED   51   33 
NOT COMPLETED   34   56 
Withdrawal by Subject                1                2 
Lost to Follow-up                4                2 
Lack of Efficacy                29                52 



  Baseline Characteristics

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 A

A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets

Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.

Standardized Anticholinergic Regimen

A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.

Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months

Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon

Total Total of all reporting groups

Baseline Measures
   Botox A   Standardized Anticholinergic Regimen   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   126   247 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (10.8)   56.7  (11.6)   57.9  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      121 100.0%      126 100.0%      247 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      22  18.2%      22  17.5%      44  17.8% 
Not Hispanic or Latino      99  81.8%      104  82.5%      203  82.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.8%      1   0.8%      2   0.8% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      1   0.8%      0   0.0%      1   0.4% 
Black or African American      18  14.9%      23  18.3%      41  16.6% 
White      96  79.3%      98  77.8%      194  78.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      5   4.1%      4   3.2%      9   3.6% 
Marital Status 
[Units: Participants]
Count of Participants
     
Married or living as married   58   57   115 
Divorced, separated, or widowed   44   48   92 
Single, never married   15   16   31 
Other   0   1   1 
Not reported   4   4   8 
Educational level at least some college 
[Units: Participants]
Count of Participants
 86   90   176 
Type of health insurance 
[Units: Participants]
Count of Participants
     
Private only   61   60   121 
Medicare or Medicaid only   10   16   26 
Other only   28   34   62 
Combination of several types   21   16   37 
Not reported   1   0   1 
Smoking status 
[Units: Participants]
Count of Participants
     
Never smoked   66   74   140 
Previous smoker   39   40   79 
Current smoker   15   12   27 
Not reported   1   0   1 
Menopausal status 
[Units: Participants]
Count of Participants
     
Premenopausal   15   22   37 
Postmenopausal   102   92   194 
Not sure   4   12   16 
No prior anticholinergic therapy 
[Units: Participants]
Count of Participants
 48   54   102 


  Outcome Measures

1.  Primary:   Change in Urge Urinary Incontinence (UUI) Episodes   [ Time Frame: Baseline through 6 months ]

2.  Secondary:   Change From Baseline in Score on OABq-SF   [ Time Frame: Baseline through 6 months ]

3.  Secondary:   Efficacy   [ Time Frame: 6 months ]

4.  Secondary:   Change in PFDI-SF and PFIQ-SF Total Scores   [ Time Frame: Baseline through 6 months ]

5.  Secondary:   Patient Global Impression of Improvement   [ Time Frame: 3 and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT 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. Marie Gantz
Organization: RTI International
phone: 919-597-5110
e-mail: mgantz@rti.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dwallace, NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT01166438     History of Changes
Other Study ID Numbers: PFDN 17
2U01HD041249 ( U.S. NIH Grant/Contract )
2U10HD041250 ( U.S. NIH Grant/Contract )
2U10HD041261 ( U.S. NIH Grant/Contract )
2U10HD041267 ( U.S. NIH Grant/Contract )
1U10HD054136 ( U.S. NIH Grant/Contract )
1U10HD054214 ( U.S. NIH Grant/Contract )
1U10HD054215 ( U.S. NIH Grant/Contract )
1U10HD054241 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2010
First Posted: July 21, 2010
Results First Submitted: April 18, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017