Trial Outcomes & Findings for Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI (NCT NCT01878500)

Results Overview

A failed bladder closure was defined as bladder prolapse, dehiscence, outlet obstruction, persistent vesicourethral fistula, or a combination of these, or a complication that required repeat closure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

2 years

Results posted on

2021-12-21

Participant Flow

All patients with bladder exstrophy were recruited. Those who were undergoing exstrophy closure with pelvic osteotomy were included. Those who did not have planned pelvic osteotomy prior to closure were excluded (1).

Participant milestones

Participant milestones
Measure	Intraoperative Stereotactic Imaging Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative Stereotactic Imaging n=47 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Age, Categorical <=18 years	47 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=47 Participants
Age, Continuous	28.6 weeks n=47 Participants
Sex: Female, Male Female	20 Participants n=47 Participants
Sex: Female, Male Male	27 Participants n=47 Participants
Region of Enrollment United States	47 Participants n=47 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

A failed bladder closure was defined as bladder prolapse, dehiscence, outlet obstruction, persistent vesicourethral fistula, or a combination of these, or a complication that required repeat closure.

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Success or Failure of Exstrophy Closure Successful	44 exstrophy closures
Success or Failure of Exstrophy Closure Failed	0 exstrophy closures

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected.

Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperatively

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Time (measured in minutes) of operation.

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Operative Time	619 minutes Interval 503.0 to 647.0

SECONDARY outcome

Timeframe: Up to 2 months

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Length of hospital stay (in days) for each participant.

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Length of Hospital Stay	50 days Interval 45.0 to 54.0

SECONDARY outcome

Timeframe: Intraoperatively

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Peri-operative complications were those encountered immediately before, during, or immediately following the case, primarily regarding need for blood transfusions. Though these are not complications (and deemed necessary/inherent to the operation), they are tracked closely as an outcome measure.

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Peri-operative Complications as Assessed by the Total Number of Transfusions	26 transfusions

SECONDARY outcome

Timeframe: Intraoperatively

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Surgeon's were surveyed post-operatively on whether the intervention improved identification of pelvic floor anatomy. Measure: Binary, 'Yes' and 'No'

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon Yes	44 Participants
Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon No	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Post-operative complications were graded on the Clavien-Dindo Classification System. The Clavien-Dindo System is a standardized classification for reporting and registering complications. It grades the severity of a complication based on the therapy required to treat the complication. It is a tiered system with subdivided categories as follows: Grade I and II are considered minor, Grade III is considered moderate and Grades IV and V are severe complications.

Outcome measures

Outcome measures
Measure	Intraoperative Stereotactic Imaging n=44 Participants Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Total Number of Post-operative Complications Overall complications	10 Post-operative complications
Total Number of Post-operative Complications Grade I	3 Post-operative complications
Total Number of Post-operative Complications Grade II	3 Post-operative complications
Total Number of Post-operative Complications Grade IIIb	4 Post-operative complications

Adverse Events

Intraoperative Stereotactic Imaging

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intraoperative Stereotactic Imaging n=44 participants at risk Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Intraoperative stereotactic imaging with VectorVision: Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
Skin and subcutaneous tissue disorders Wound Dehiscence	2.3% 1/44 • Number of events 1 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Renal and urinary disorders Acute Kidney Injury	4.5% 2/44 • Number of events 2 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Infections and infestations Wound infection	9.1% 4/44 • Number of events 4 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Infections and infestations Pin site infection	2.3% 1/44 • Number of events 1 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Renal and urinary disorders Urine leak	2.3% 1/44 • Number of events 1 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.
Renal and urinary disorders Ureteral obstruction	2.3% 1/44 • Number of events 1 • 2 years Complications were graded on the Clavien-Dindo Classification Scheme to stratify minor from major complications. 3 patients were simple cystectomies and thus did not represent bladder closures and were subsequently excluded from final analysis.

Additional Information

Dr. John P Gearhart

Johns Hopkins University

Phone: 410-955-5358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place