The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial

Area of Science:

• Urology
• Clinical Trials
• Pharmacology

Background:

• Refractory urgency urinary incontinence (UUI) significantly impacts quality of life.
• Limited treatment options exist for patients unresponsive to conservative therapies.
• Onabotulinum toxin A and sacral neuromodulation represent distinct therapeutic approaches.

Purpose of the Study:

• To compare the efficacy and safety of onabotulinum toxin A versus sacral neuromodulation for refractory UUI in women.
• To evaluate changes in lower urinary tract symptoms, adverse events, and cost-effectiveness.
• To provide data for healthcare providers on these two interventions.

Main Methods:

• Randomized, open-label, active-control trial (ROSETTA).
• Participants received either 200 units of onabotulinum toxin A or sacral neuromodulation.
• Comparison of urgency urinary incontinence episodes over a 6-month period.
• Inclusion criteria: failure of at least two medications and behavioral therapy.

Main Results:

• The ROSETTA trial is designed to compare treatment outcomes.
• Data on efficacy, safety, and cost-effectiveness will be collected over 6 months.
• Analysis will include changes in UUI episodes and other lower urinary tract symptoms.

Conclusions:

• The ROSETTA trial will offer valuable insights into managing refractory UUI.
• Findings will guide clinical decision-making regarding onabotulinum toxin A and sacral neuromodulation.
• The study addresses important considerations including cost-effectiveness and patient outcomes.