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Onderzoek naar de optimale duur van de testperiode van behandeling met sacrale neuromodulatie.

Time of onset and time of offset of sacral neuromodulation effect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25907
Enrollment
40
Registered
2013-11-12
Start date
2013-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

overactive bladder (OAB) non-obstructive urinary retention (NOR) sacral neuromodulation (SNM) overactieve blaas niet-obstructieve urine retentie sacrale neuromodulatie

Interventions

After inclusion and informed consent, patients will fill out a baseline voiding diary throughout seven days. The 28 day test stimulation period starts on the day of the first tined lead procedure. On

Sponsors

Department of Urology, dr. van Koeveringe, urologist Maastricht Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should have been diagnosed with overactive bladder syndrome or non-obstructive urinary retention and should be put on the waiting list for scheduling treatment with sacral neuromodulation.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: a) patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease; b) patients who have been treated by means of bladder wall botuline toxine injections in the past twelve months; c) patients with evident subsequent complains of bladder pain syndrome or other pelvic pain.

Design outcomes

Primary

MeasureTime frame
The transition point between no effect and time of onset is determined by assessing when certain complaints parameters are reduced by 50% compared to baseline per 24 hours. Vice versa (50% increase) for offset of effect. Onset and offset of effect will be assessed in days.

Secondary

MeasureTime frame
Not applicable.

Contacts

Public ContactJ. Drossaerts

Maastricht Universitair Medisch Centrum Afdeling Urologie | P. Debyelaan 25 | postbus 5800

043-3877255

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)