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Clinical Trials/ISRCTN37385347
ISRCTN37385347
Completed
Not Applicable

Prospective randomized blinded study evaluating ultrasound versus fluoroscopy guided sacral InterStim® lead placement

Metro Health Hospital0 sites40 target enrollmentJanuary 10, 2017
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ConditionsOveractive bladder, fecal incontinenceNervous System Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive bladder, fecal incontinence
Sponsor
Metro Health Hospital
Enrollment
40
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 10, 2017
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Metro Health Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosis of overactive bladder, non\-obstructive urinary retention, or fecal incontinence
  • •2\. Aged 18 years or older
  • •3\. Failure of previous conservative measures (i.e. behavior modification, biofeedback, pelvic floor training, at least one antimuscarinic or beta\-agonist medication)
  • •4\. Medically fit to undergo proposed surgery
  • •5\. Patient able to consent

Exclusion Criteria

  • •1\. Pregnant or planning on becoming pregnant
  • •2\. Severe or uncontrolled diabetes with peripheral nerve involvement
  • •3\. Knowledge of planned MRI or other procedures precluding implantation of device or need for removal
  • •4\. Severe BPH, prostate cancer, urethral stricture, or other mechanical obstruction
  • •5\. Active urinary tract, skin, or soft tissue infection

Outcomes

Primary Outcomes

Not specified

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