Overactive BladderNCT01644409
Urgent-SQ in Treatment of Overactive Bladder Syndrome: 9-yr Follow up
An observational study of Overactive Bladder and Urinary Frequency or Urgency Adverse Event, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Frequency or Urgency Adverse Event, Urinary Incontinence, Urge
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant
Who may be able to join
- Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004
Who cannot join
- Patient who had the implant removed before the first year after implantation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud Unviversity Nijmegen Medical Centre
Nijmegen, Gelderland, 6500
About this study
Official title: Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).
Read the detailed description
This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The implant is placed via an minimal invasive surgical procedure. The implant can be activated with an external pulse generator.
This study by van de Pal et al. was conducted with the approval of the local Medical Ethical Committee and with a one year systematic follow-up of eight patients. Since then, follow-up up and use of the device was open-label.
This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ implant in these eight patients.
Parameters evaluated were local pain and discomford at the site of the implant, AE's related to the implant or the use of the implant. Current use of the treatment and effectivity of the treatment.
van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.
- Conditions
- Overactive Bladder, Urinary Frequency or Urgency Adverse Event, Urinary Incontinence, Urge
- Keywords
- OAB, Overactive bladder, Urgency, Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dick Janssen, Radboud University Medical Center
- Investigators
- Dick Janssen, MD, Principal investigator, Radboud University Nijmegen Medical Centre Dept of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644409
- Sponsor's protocol ID
- USQ-9yr
- Other IDs
- USQ-9yr
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL. Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.x.
PubMed 22151641
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
- ClinicalTrials.gov ID
- NCT01644409
- Acronym / sponsor ID
- USQ-9yr
- Conditions
- Overactive Bladder, Urinary Frequency or Urgency Adverse Event, Urinary Incontinence, Urge
- Keywords
- OAB, Overactive bladder, Urgency, Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).
Detailed description
This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The implant is placed via an minimal invasive surgical procedure. The implant can be activated with an external pulse generator.
This study by van de Pal et al. was conducted with the approval of the local Medical Ethical Committee and with a one year systematic follow-up of eight patients. Since then, follow-up up and use of the device was open-label.
This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ implant in these eight patients.
Parameters evaluated were local pain and discomford at the site of the implant, AE's related to the implant or the use of the implant. Current use of the treatment and effectivity of the treatment.
van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant
Key inclusion criteria (1 listed)
- Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004
Key exclusion criteria (1 listed)
- Patient who had the implant removed before the first year after implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Results publication: PubMed 22151641van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL. Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dick Janssen, MD principal investigator
Radboud University Nijmegen Medical Centre Dept of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Urinary Frequency or Urgency Adverse Event, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.