Interstitial CystitisNCT00590473
Sacral Neuromodulation in Patients With IC
A study testing Interstim in people with Interstitial Cystitis, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Interstim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2009
- 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 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Diagnosis of interstitial cystitis for at least 6 months.
- At least 18yrs old and less than 80.
- Symptoms of urgency (>4 on the visual analog scale).
- Symptoms of urinary frequency (>8 episodes/day as recorded on a voiding diary)
- Symptoms of pelvic pain (>4 on the visual analog scale for pelvic pain).
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- Interstitial Cystitis refractory to more conservative treatments such as behavioral modification, dietary intervention, or medical therapy for at least 6 months.
- Able to make medical decisions for herself.
- Presence of either glomerulations of Hunner's ulcer on cystoscopic examination.
- Participant must agree to use a medically acceptable method of contraception throughout the entire study period, and for 7 days after the study period. Medically acceptable methods of contraception include abstinence, birth control pills or patches, diaphragm with spermicide, IUD, condom with vaginal spermicide, surgical sterilization, post menopausal for at least 1 year, implants or injections, or vasectomized partner.
- Must give written informed consent to participate in this study.
Who cannot join
- Prior sacral neuromodulation.
- Participant is currently pregnant or breastfeeding.
- Male.
- Urinary retention (defined by post void residual greater than 100cc).
- Neurologic deficit.
- Need for future MRI surveillance.
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- Involved in any study within the past thirty days or currently enrolled.
- Presence of bladder or ureteral calculi.
- Active genital herpes.
- Uterine, cervical, vaginal, or urethral cancer.
- Urethral diverticulum.
- Cyclophosphamide cystitis.
- Vaginitis.
- Tuberculous cystitis.
- Foreign body within the bladder (indwelling catheter- foley or suprapubic tube, or ureteral stent).
- An employee or a relative of an employee of Medtronic Inc. or The Pelvic and Sexual Health Institute.
- Bladder capacity greater than 350 cc while awake during cystometrogram.
- Duration of symptoms of less than 6 months.
- Detrusor overactivity on cystometrogram.
- Absence of nocturia, defined by greater than 2 voids per sleeping hours.
- Urinary symptoms relieved by either antimicrobials, antiseptics, anticholinergics, or antispasmodics.
- Urinary frequency of less than 8 voids per day.
- Diagnosis of bacterial cystitis or prostatitis within the past 3 months.
- Radiation cystitis.
- Benign or malignant bladder tumors.
- Age less than 18 or greater than 79.
- Participant is currently receiving or has received pelvic radiation.
- Participant is diagnosed with cancer within the past 5 years prior to the start of the study.
- Participant has a history of alcohol or substance abuse within the past 5 years prior to the start of the study.
- Severe or uncontrolled diabetes or diabetes with peripheral nerve involvement.
- Patients with implanted electrical devices (cardiac pacemakers or defibrillators).
- Patients on anticoagulation therapy.
- Planned future exposure to diathermy, microwave, or RF energy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis
The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.
This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.
- Conditions
- Interstitial Cystitis
- Being tested
- Interstim
- Keywords
- Interstitial Cystitis, IC, Neuromodulation, Interstim Therapy
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterstimDevice
Unilateral vs. Bilateral Placement of Interstim IPG
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Unilateral Placement of Interstim IPG Receives: Device: Interstim |
| 2 | Active comparator | Bilateral Placement of Interstim IPG Receives: Device: Interstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis.
Measured: Post-op, at 6 weeks and at 3 months post-surgery
Secondary outcomes (1)
To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis
Measured: Post-op, at 6 weeks and 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Kristene E. Whitmore, M.D., Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590473
- Sponsor's protocol ID
- 71692
- Status last verified
- Apr 2017
- First submitted
- 26 Dec 2007
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT00590473
- Acronym / sponsor ID
- 71692
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial Cystitis, IC, Neuromodulation, Interstim Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 10 Jan 2008 (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.
The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.
This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: InterstimUnilateral Placement of Interstim IPG |
| 2 | Active comparator | Device: InterstimBilateral Placement of Interstim IPG |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Diagnosis of interstitial cystitis for at least 6 months.
- At least 18yrs old and less than 80.
- Symptoms of urgency (>4 on the visual analog scale).
- Symptoms of urinary frequency (>8 episodes/day as recorded on a voiding diary)
Key exclusion criteria (33 listed)
- Prior sacral neuromodulation.
- Participant is currently pregnant or breastfeeding.
- Male.
- Urinary retention (defined by post void residual greater than 100cc).
- Neurologic deficit.
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 |
|---|---|---|
| InterstimUnilateral vs. Bilateral Placement of Interstim IPG | Device | 1, 2 |
Primary outcome
To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis.
Time frame: Post-op, at 6 weeks and at 3 months post-surgery
1 secondary outcome
To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis
Time frame: Post-op, at 6 weeks and 3 months post-surgery
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 10 Apr 2017.
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Investigation of PEMF Therapy for Female Patients With IC/BPS
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Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
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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.
Kristene E. Whitmore, M.D. principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interstim in people with Interstitial Cystitis, run by Drexel University College of Medicine 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?
The sponsor lists 11 inclusion and 33 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 10 Apr 2017. 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.
What does the primary outcome measure?
To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis. (time frame: Post-op, at 6 weeks and at 3 months post-surgery). 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 10 Apr 2017.