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Optimal Stimulation Rates in Sacral Neuromodulation Therapy

Optimal Stimulation Rates in Sacral Neuromodulation Therapy - Rate study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31616
Enrollment
54
Registered
2007-12-10
Start date
2008-09-02
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

incontinence overactive bladder urinary retention

Interventions

Change the pulse rate of the implanted neurostimulator in patients with implanted neuromodulation system. Frequencies will be changed to 5.2Hz, 10Hz, 25Hz and 40Hz, each frequency will be used durin

Sponsors

Academisch Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with Sacral Neuromodulation therapy for complaints of urge incontinence, urgency frequency, hypocontractile detrusor or obstruction due to urethral sphincter overactivity.

Exclusion criteria

Exclusion criteria: Patients with Sacral Neuromodulation Therapy for other reasons than mentioned in the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Improvement in voiding diaries results between the *standard* frequency (10 Hz) and pulsewidth (210µs) and new settings. Improvement is measured by computer assisted comparison of voiding diaries taken with the *standard* settings and with the new settings and is reflected in percentage improvement achieved

Secondary

MeasureTime frame
* Patient toleration of rate changes. * Difference between optimal settings between patients with either urge symptoms or retention symptoms.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)