NCT01312259|UnknownPhase 4
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Sponsor study identifier
interventional
72
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Purpose:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2011
Actual (reported)March 10, 2011
Actual (reported)April 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
1 year
Improvement in Bowel symptoms and Sexual Function
1 year
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, 19107, United States
Kristene E Whitmore, MD
Drexel University College of Medicine
First Submitted
March 8, 2011
First Posted
March 10, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 29, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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