Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)NCT00200031
A Cost Analysis of Interstim Therapy
An observational study of Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency), run by MedtronicNeuro at 1 site in United States.
Trial summary
A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)
- What is being tested?
- Interstim therapy
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2006
- 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
- Adult, Older adult
Patients implanted with an Interstim Therapy for Urinary Control or undergoing test stimulation for potential placement of Interstim Therapy during the period of June 1, 2002 through June 30, 2004 and who are enrolled with Kaiser-Permanente of Southern California.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Permanente Medical Group
Los Angeles, California, 90027
About this study
Official title: Interstim Therapy Retrospective Cost Analysis and Quality of Life
A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy.
Read the detailed description
A retrospective administrative data analysis combined with a prospective health related quality of life/satisfaction with treatment survey designed to examine the impact that Interstim Therapy for Urinary Control has had on health care utilization and costs for the Kaiser Permanente system and the satisfaction with treatment expressed by patients using this therapy.
- Being tested
- Interstim therapy
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstim therapyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Study completionApr 2006
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 Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)Studies of the same condition, open and under way.
- 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
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sherif Aboseif, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200031
- Sponsor's protocol ID
- 4348
- Status last verified
- Jul 2008
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jul 2008
- Results posted
- No
Publications
Aboseif SR, Kim DH, Rieder JM, Rhee EY, Menefee SA, Kaswick JR, Ree MH. Sacral neuromodulation: cost considerations and clinical benefits. Urology. 2007 Dec;70(6):1069-73; discussion 1073-4. doi: 10.1016/j.urology.2007.07.073.
PubMed 18158016
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstim Therapy Retrospective Cost Analysis and Quality of Life
- ClinicalTrials.gov ID
- NCT00200031
- Acronym / sponsor ID
- 4348
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 20 Sep 2005 (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.
A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy.
Detailed description
A retrospective administrative data analysis combined with a prospective health related quality of life/satisfaction with treatment survey designed to examine the impact that Interstim Therapy for Urinary Control has had on health care utilization and costs for the Kaiser Permanente system and the satisfaction with treatment expressed by patients using this therapy.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Interstim therapy | Device | – |
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 28 Jul 2008.
- Results publication: PubMed 18158016Aboseif SR, Kim DH, Rieder JM, Rhee EY, Menefee SA, Kaswick JR, Ree MH. Sacral neuromodulation: cost considerations and clinical benefits. Urology. 2007 Dec;70(6):1069-73; discussion 1073-4. doi: 10.1016/j.urology.2007.07.073.
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.
Sherif Aboseif, MD principal investigator
Kaiser Permanente
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 Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency), run by MedtronicNeuro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jul 2008. 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 United States. 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 NCT00200031, 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 28 Jul 2008; AzTrials last refreshed its copy on 31 Oct 2026.