Status:
COMPLETED
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
Duke University
University of Alabama at Birmingham
Conditions:
Urinary Incontinence, Urge
Eligibility:
FEMALE
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Med...
Detailed Description
Primary Aim: To compare the change from baseline in the number of urge urinary incontinence episodes (UUIE) over 6 the six month follow-up period in women randomized to sacral neuromodulation (InterS...
Eligibility Criteria
Inclusion
- Non-pregnant adult female at least 21 years old, with no plans to become pregnant during the course of the trial) and if of child-bearing potential, with a negative pregnancy test, and if sexually active, must be using medically acceptable contraception.
- 6 urge urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of the total incontinent episodes recorded.
- Willing and able to complete all study related items and interviews.
- Refractory urinary urge urinary incontinence: defined as (1) Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy); and (2)Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a contraindication to taking anticholinergic medication.
- Currently not on an anticholinergic or antimuscarinic medication (e.g. oxybutynin, tolterodine, and/or fesoterodine) or be willing to stop medication for 3 weeks prior to completing baseline bladder diary and expected to remain off medications through duration of study.
- Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
- Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.
- Urodynamic assessment within the previous 18 months prior to enrollment or done after enrollment, prior to randomization.
Exclusion
- Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth disease, clinically significant peripheral neuropathy, and complete spinal cord injury.
- Untreated urinary tract infection (UTI).
- Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).
- Current participation in any other conflicting interventional research study.
- PVR \>150 ml on 2 occasions within 6 months prior to enrollment (If the PVR value was obtained by ultrasound and was ≥150 ml, the PVR will be confirmed by catheterization which will be the gold standard)
- Subjects with knowledge of planned MRIs or diathermy, except those allowable per Medtronic guidelines.
- Current or prior bladder malignancy.
- Surgically altered detrusor muscle, such as augmentation cystoplasty.
- Subjects taking aminoglycosides.
- Currently pregnant or lactating.
- Subjects who are on ambulatory anticoagulant therapy, including aspirin, who are unable to discontinue treatment for 24 hours prior to bladder injection and staged InterStim® procedure.
- Serum creatinine level greater than twice the upper limit of normal within the previous year prior to enrollment.
- Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
- Prior stress incontinence or prolapsed surgery within the last 6 months prior to enrollment.
- Allergy to lidocaine or bupivacaine.
- Prior pelvic radiation.
- Uninvestigated hematuria.
- Greater than or equal to Stage III vaginal prolapse.
- Known allergy to Botox A®.
- Use of a vaginal pessary.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT01502956
Start Date
February 1 2012
End Date
July 1 2016
Last Update
May 2 2018
Active Locations (9)
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1
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States, 35249-7333
2
University of California, San Diego, Women's Pelvic Medicine Center
La Jolla, California, United States, 92037
3
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131-0001
4
Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 277707