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

NCT02040519 | Completed

• 1 other identifier: NL44879.068.13
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder; Non Obstructive Urinary Retention

Keywords

Overactive bladder; Non obstructive urinary retention; Sacral neuromodulation

Outcome Measures

Primary Outcomes (1)

• Time of onset of effect of treatment with sacral neuromodulation

  28 days

Study Arms (1)

Evaluation by voiding diaries

EXPERIMENTAL

Behavioral: Filling out voiding diaries.

Interventions

Filling out voiding diaries. BEHAVIORAL

Evaluation by voiding diaries

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• G. A. van Koeveringe, urologist

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

NL (1)