Your session is about to expire
← Back to Search
Neuromodulation
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Phase 4
Waitlist Available
Led By Kristene E Whitmore, MD
Research Sponsored by Pelvic and Sexual Health Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
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. 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).
Eligible Conditions
- Irritable Bowel Syndrome
- Painful Bladder Syndrome
- Sexual Dysfunction
- Pelvic Floor Dysfunction
- Interstitial Cystitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in Urinary symptoms and Bladder pain/discomfort
Secondary study objectives
Improvement in Bowel symptoms and Sexual Function
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interstim Parameter Frequency 40 HZExperimental Treatment1 Intervention
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.
Group II: Interstim Parameter Frequency 14 HZActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Pelvic and Sexual Health InstituteLead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
Kristene E Whitmore, MDPrincipal InvestigatorDrexel University College of Medicine
2 Previous Clinical Trials
37 Total Patients Enrolled