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Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) (ROSETTA)

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ClinicalTrials.gov Identifier: NCT01502956
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : March 8, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Duke University
University of Alabama at Birmingham
University of California, San Diego
The Cleveland Clinic
Brown University
University of New Mexico
University of Pennsylvania
University of Pittsburgh
Oregon Health and Science University
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Urinary Incontinence, Urge
Interventions: Device: InterStim® device
Drug: Botox® injection

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women who have persistent severe UUI symptoms, defined as ≥6 UUI episodes on a 3-day bladder diary are recruited from urology and urogynecology subspecialty clinics as well as by other marketing methods.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
InterStim® Device

The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.

InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d

Botox® Injection

Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.

Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.


Participant Flow:   Overall Study
    InterStim® Device   Botox® Injection
STARTED   192   194 
COMPLETED   168   168 
NOT COMPLETED   24   26 
Death                0                2 
Lost to Follow-up                14                11 
Physician Decision                2                3 
Withdrawal by Subject                8                10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible participants who provided at least 1 post-baseline diary assessment.

Reporting Groups
  Description
InterStim® Device The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
Botox® Injection Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Total Total of all reporting groups

Baseline Measures
   InterStim® Device   Botox® Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 174   190   364 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (11.8)   62.9  (11.5)   63.0  (11.6) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age <65 years   91   100   191 
Age => 65 years   83   90   173 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Female   174   190   364 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      10   5.7%      18   9.5%      28   7.7% 
Not Hispanic or Latino      160  92.0%      167  87.9%      327  89.8% 
Unknown or Not Reported      4   2.3%      5   2.6%      9   2.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   149   154   303 
Black   16   22   38 
American Indian/Alaska Native   1   4   5 
Asian   1   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Other   7   9   16 
Menopausal Status 
[Units: Participants]
Count of Participants
     
Pre-menopausal      18  10.3%      20  10.5%      38  10.4% 
Post-menopausal      149  85.6%      162  85.3%      311  85.4% 
Not sure      7   4.0%      8   4.2%      15   4.1% 
History of Recurrent UTIs 
[Units: Participants]
Count of Participants
     
No history of recurrent UTIs      149  85.6%      166  87.4%      315  86.5% 
History of recurrent UTIs      25  14.4%      24  12.6%      49  13.5% 
Urinary Incontinence Episodes Per Day 
[Units: Episodes per day]
Mean (Standard Deviation)
     
Total incontinence episodes per day   5.8  (3.0)   6.0  (3.0)   5.9  (3.0) 
Urge incontinence episodes per day   5.2  (2.7)   5.4  (2.7)   5.3  (2.7) 
Nocturia (number of night voids per day) 
[Units: Voids per day]
Mean (Standard Deviation)
 1.7  (1.4)   1.7  (1.2)   1.7  (1.3) 
Overactive Bladder Questionnaire – Short Form (OABq-SF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
OABq-SF Symptom Bother   76.1  (16.8)   74.6  (19.5)   75.3  (18.3) 
OABq-SF Quality of Life   36.8  (21.6)   38.2  (23.0)   37.5  (22.3) 
[1] Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating better quality of life.
Urinary Frequency and Nocturia - Sandvik Questionnaire [1] 
[Units: Participants]
Count of Participants
     
Slight   1   2   3 
Moderate   25   27   52 
Severe   38   52   90 
Very Severe   105   103   208 
[1] Patient-reported measure of incontinence severity as assessed on a scale of slight (1-2) to very severe (10-12) using the standard scoring algorithm.
Urinary Distress Inventory Short Form (UDI-SF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 59.2  (16.9)   60.9  (18.3)   60.1  (17.7) 
[1] Values range from 0 to 100 with higher scores indicating greater distress.
Incontinence Impact Questionnaire Short Form (IIQ-SF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 52.5  (25.8)   52.7  (27.6)   52.6  (26.7) 
[1] Values range from 0 to 100 with higher scores indicating worse quality of life.
Health Utilities Index Mark 3 (HUI-3) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.74  (0.28)   0.71  (0.30)   0.73  (0.29) 
[1] Values are defined such that the score for dead is 0; the score for perfect health is 1.0.


  Outcome Measures

1.  Primary:   Number of Urge Urinary Incontinence (UUI) Episodes   [ Time Frame: 6 Months ]

2.  Secondary:   Number of Participants With Improvement of Bladder Function and Urinary Leakage   [ Time Frame: 6 Months ]

3.  Secondary:   Change in Overactive Bladder   [ Time Frame: 6 Months ]

4.  Secondary:   Urinary Frequency and Nocturia   [ Time Frame: 6 Months ]

5.  Secondary:   Severity of Urge Incontinence Symptoms   [ Time Frame: 6 Months ]

6.  Secondary:   Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)   [ Time Frame: 6 months ]

7.  Secondary:   Treatment Satisfaction (OAB-SATq Treatment Preference)   [ Time Frame: 6 Months ]

8.  Secondary:   Quality of Life (UDI-SF)   [ Time Frame: 6 Months ]

9.  Secondary:   Quality of Life (IIQ-SF)   [ Time Frame: 6 Months ]

10.  Secondary:   Quality of Life (HUI-3)   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marie Gantz
Organization: RTI International
phone: 919-597-5110
e-mail: mgantz@rti.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT01502956     History of Changes
Other Study ID Numbers: PFDN 20
U01HD069031 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2011
First Posted: January 2, 2012
Results First Submitted: October 3, 2017
Results First Posted: March 8, 2018
Last Update Posted: May 2, 2018