Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation

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

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-02-06

Brief Summary

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Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to conservative treatment. Success rates range from 70 to 80%, and good long-term results are reported. The working mechanism of SNM is not completely understood, and the only prognostic factor for good response to this treatment is a successful test stimulation period. There is no consensus on the duration of this test stimulation period. The experience in our clinic during test stimulation period is that for responders it takes up to one week to achieve maximal effect, after the system is turned 'on'. On the other hand the investigators notice that after turning the neuromodulation system 'off', it will take a few hours for symptoms to return to the baseline situation. The fact is: no information concerning the so called "time of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral neuromodulation is available in current literature.

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Detailed Description

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Conditions

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Overactive Bladder Non Obstructive Urinary Retention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evaluation by voiding diaries

Group Type EXPERIMENTAL

Filling out voiding diaries.

Intervention Type BEHAVIORAL

Interventions

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Filling out voiding diaries.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 and should be put on the waiting list for scheduling treatment with sacral neuromodulation.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease
* patients who have been treated by means of bladder wall botulin toxin injections in the previous year
* patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No