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Time of onset and time of offset of sacral neuromodulation effect.

Time of onset and time of offset of sacral neuromodulation effect. - Wash in - wash out

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50444
Enrollment
40
Registered
2014-01-02
Start date
2014-03-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Non-obstructive urinary retention (NOR) Overactive bladder (OAB)

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. O

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 symptoms are reduced by 50% compared to baseline. Vice versa for time of offset. Time of on set and offset will be assessed in days (24 hours).

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)