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Clinical Trials/NL-OMON56105
NL-OMON56105
Not yet recruiting
Not Applicable

The influence of sacral neuromodulation on brain areas involved in the sensation of bladder filling in patients with Overactive Bladder (OAB) using fMRI - fMRI study of the influence of sacral neuromodulation on brain activity

Medisch Universitair Ziekenhuis Maastricht0 sites95 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
95
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • 1\. Female subjects above 18 years of age.
  • 2\. Has provided written informed consent prior to any study related procedures.
  • 3\. Indication for treatment with sacral neuromodulation (for patient group)
  • 4\. History of signs and symptoms of OAB including urinary frequency, urgency or
  • urge incontinence for greater than or equal to 3 months. (for patient group)
  • 5\. The subjects must have (for patient group):
  • a. At least 1 episode of urgency with or without incontinence in the last 3\-day
  • micturition diary.

Exclusion Criteria

  • 1\. Stress urinary incontinence more profound than urge urinary incontinence,
  • urethral sphincter incompetence and neurogenic detrusor overactivity.
  • 2\. Current urinary tract infection (confirmed by positive urine analysis).
  • 3\. Bladder outlet obstruction (not including detrusor\-overactivity), for
  • example bladder/vesico\-uterine prolapse (\> grade II) or chronic obstruction.
  • 4\. History of urinary tract surgery less than or equal to 6 months prior to
  • 5\. Intermittent catheterization or permanent catheter.
  • 6\. History of pelvic area radiotherapy treatment.
  • 7\. Has a history of treatment of OAB with botulinum toxin within less than 12
  • months prior to screening.

Outcomes

Primary Outcomes

Not specified

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