Sacral Neuromodulation & Urodynamics

NCT ID: NCT03614767

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-07-31

Brief Summary

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In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).

Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy

Detailed Description

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Conditions

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Overactive Bladder Non-obstructive Urinary Retention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Successes

Patients with \>50% improvement during test procedure of sacral neuromodulation.

urodynamics

Intervention Type DIAGNOSTIC_TEST

Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.

Failures

Patients with \<50% improvement during test procedure of sacral neuromodulation.

urodynamics

Intervention Type DIAGNOSTIC_TEST

Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.

Interventions

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urodynamics

Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Ice water test Slider

Eligibility Criteria

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Inclusion Criteria

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria

* Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Donald Vaganée

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan De Wachter, MD PhD FEBU

Role: STUDY_DIRECTOR

University Hospital, Antwerp

Locations

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University of antwerp

Antwerp, Edegem, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Stefan De Wachter, MD PhD FEBU

Role: CONTACT

8215934 ext. 323

Facility Contacts

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Stefan De Wachter, MD PhD FEBU

Role: primary

Other Identifiers

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17/30334

Identifier Type: -

Identifier Source: org_study_id

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