Painful Bladder SyndromePhase 4NCT01312259
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
A Phase 4 study testing Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Pelvic and Sexual Health Institute at 1 site in United States.
Trial summary
Purpose: 1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard). 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor; Insufficiency
- What is being tested?
- Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2018
- Phase
- Phase 4
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with diagnosis of IC/PBS with implanted IPG Interstim.
- Scores > 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and > 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
- Signed Informed Consent.
Who cannot join
- Progressive neurologic disease or peripheral neuropathy.
- History of bladder surgery.
- Subjects implanted with other neuromodulation device.
- Current or planning pregnancy; Breastfeeding.
- Subjects who are not deemed able to fill questionnaires
- Mental illness or mentally unstable patients
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, 19107
Elizabeth Elias, CCRP, 267-479-2397
Salim A Wehbe, MD
About this study
Purpose:
- To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
Read the detailed description
Purpose:
- Primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- Secondary: The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor; Insufficiency, Bowel Dysfunction, Sexual Dysfunction, Pelvic Floor; Incompetency
- Being tested
- Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
- Keywords
- Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor dysfunction, Fecal incontinence, Constipation, Sexual dysfunction, Dyspareunia, Vulvodynia
- Medical subject headings
- Cystitis, Interstitial, Intestinal Diseases, Sexual Dysfunction, Physiological, Fecal Incontinence, Constipation, Dyspareunia, Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing the Interstim parameter of '' Frequency" in patients with Interstitial CystitisOther
Also called InterStim, Sacralneuromodulation device, IPG (Implantable pulse generator)
Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.
| Study group | Role | What they receive |
|---|---|---|
| Interstim Parameter Frequency 14 HZ | Active comparator | Subjects in this arm will receive 14 Hx as their frequency for the first three months. For the second 3 months, these patients will receive 40 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed. Receives: Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis |
| Interstim Parameter Frequency 40 HZ | Experimental | Subjects in this arm will receive 40 Hz as their frequency for the first three months. For the second 3 months, these patients will receive 14 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed. Receives: Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Urinary symptoms and Bladder pain/discomfort
To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
Measured: 1 year
Secondary outcomes (1)
Improvement in Bowel symptoms and Sexual Function
The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Bladder SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pelvic and Sexual Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
- Investigators
- Kristene E Whitmore, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312259
- Sponsor's protocol ID
- 19522
- Status last verified
- Apr 2014
- First submitted
- 8 Mar 2011
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT01312259
- Acronym / sponsor ID
- 19522
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor; Insufficiency, Bowel Dysfunction, Sexual Dysfunction, Pelvic Floor; Incompetency
- Keywords
- Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor dysfunction, Fecal incontinence, Constipation, Sexual dysfunction, Dyspareunia, Vulvodynia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pelvic and Sexual Health InstituteUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 10 Mar 2011 (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.
Purpose:
- To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
Detailed description
Purpose:
- Primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- Secondary: The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstim Parameter Frequency 14 HZ | Active comparator | Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial CystitisSubjects in this arm will receive 14 Hx as their frequency for the first three months. For the second 3 months, these patients will receive 40 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed. |
| Interstim Parameter Frequency 40 HZ | Experimental | Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial CystitisSubjects in this arm will receive 40 Hz as their frequency for the first three months. For the second 3 months, these patients will receive 14 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female with diagnosis of IC/PBS with implanted IPG Interstim.
- Scores > 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and > 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
- Signed Informed Consent.
Key exclusion criteria (6 listed)
- Progressive neurologic disease or peripheral neuropathy.
- History of bladder surgery.
- Subjects implanted with other neuromodulation device.
- Current or planning pregnancy; Breastfeeding.
- Subjects who are not deemed able to fill questionnaires
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 |
|---|---|---|
| Changing the Interstim parameter of '' Frequency" in patients with Interstitial CystitisAlso: InterStim, Sacralneuromodulation device, IPG (Implantable pulse generator)Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months. | Other | Interstim Parameter Frequency 14 HZ, Interstim Parameter Frequency 40 HZ |
Primary outcome
Improvement in Urinary symptoms and Bladder pain/discomfort
Time frame: 1 year
To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
1 secondary outcome
Improvement in Bowel symptoms and Sexual Function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
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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, MD 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 Phase 4 study testing Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Pelvic and Sexual Health Institute 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Apr 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Elias, CCRP (267 479 2387, InterStimStudy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Urinary symptoms and Bladder pain/discomfort (time frame: 1 year). 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 29 Apr 2014.