Overactive Bladder SyndromeNCT01164280
Effect of Pulse Rate Changes on Clinical Outcome
A study testing Pulse Rate Change in people with Overactive Bladder Syndrome and Chronic Urinary Retention, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Objectives: To evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (SNM) treatment. Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder Syndrome, Chronic Urinary Retention
- What is being tested?
- Pulse Rate Change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention
- Patients with suboptimal effect of their neurostimulator
Who cannot join
- Patients with 100% effect of their neurostimulator
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, P.O. box 5800, 6202 AZ
About this study
Official title: The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation
Objectives: To evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.
Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation was kept off for 24 hours between consecutive test periods. The last 3 days of every test period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical response and pain symptoms were compared between the four pulse-rates using multivariate analysis.
Read more
Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD 12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic non-obstructive urinary retention. No significant difference was found regarding clinical outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the four pulse rates was significantly related to the occurrence of SNM-related pain. However, on individual basis, patients appear to benefit from changing the pulse rate concerning both treatment efficacy and stimulation related pain.
Conclusions: On group level, none of the four pulse rates in this study appears to have a significantly different effect on clinical outcome or SNM-related pain. However, a tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be useful.
- Being tested
- Pulse Rate Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Rate ChangeOther
Different pulse rate settings of the implantable neurostimulator
| Study group | Role | What they receive |
|---|---|---|
| Pulse Rate Change | Experimental | Patients are subjected to different pulse rate settings of their neurostimulator. The effect of pulse rate changes on clinical outcome is measured. Receives: Other: Pulse Rate Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in voiding diary variables
Secondary outcomes (1)
Improvement in subjective voiding symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Philip van Kerrebroeck, M.D., Ph.D., Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164280
- Sponsor's protocol ID
- MEC 07-2-083 (5266)
- Status last verified
- Jul 2010
- First submitted
- 14 Jul 2010
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation
- ClinicalTrials.gov ID
- NCT01164280
- Acronym / sponsor ID
- MEC 07-2-083 (5266)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Jul 2010 (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.
Objectives: To evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.
Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation was kept off for 24 hours between consecutive test periods. The last 3 days of every test period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical response and pain symptoms were compared between the four pulse-rates using multivariate analysis.
Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD 12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic non-obstructive urinary retention. No significant difference was found regarding clinical outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the four pulse rates was significantly related to the occurrence of SNM-related pain. However, on individual basis, patients appear to benefit from changing the pulse rate concerning both treatment efficacy and stimulation related pain.
Conclusions: On group level, none of the four pulse rates in this study appears to have a significantly different effect on clinical outcome or SNM-related pain. However, a tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be useful.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse Rate Change | Experimental | Other: Pulse Rate ChangePatients are subjected to different pulse rate settings of their neurostimulator. The effect of pulse rate changes on clinical outcome is measured. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention
- Patients with suboptimal effect of their neurostimulator
Key exclusion criteria (1 listed)
- Patients with 100% effect of their neurostimulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Rate ChangeDifferent pulse rate settings of the implantable neurostimulator | Other | Pulse Rate Change |
Primary outcome
Improvement in voiding diary variables
1 secondary outcome
Improvement in subjective voiding symptoms
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 16 Jul 2010.
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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.
Philip van Kerrebroeck, M.D., Ph.D. principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Rate Change in people with Overactive Bladder Syndrome and Chronic Urinary Retention, run by Maastricht 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 2 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 16 Jul 2010. 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.
What does the primary outcome measure?
Improvement in voiding diary variables. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2010; AzTrials last refreshed its copy on 4 Nov 2026.