Sacral Neuromodulation for Neurogenic LUT Dysfunction

• ClinicalTrials.gov Identifier: NCT02165774
• Recruitment Status: Completed
• First Posted: June 17, 2014
• Last Update Posted: January 9, 2018
• Sponsor: University of Zurich
• Collaborators: University Hospital Inselspital, Berne; Swiss Paraplegic Centre Nottwil; Cantonal Hospital of St. Gallen
• Information provided by (Responsible Party): University of Zurich

Tracking Information

• First Submitted Date: June 2, 2014
• First Posted Date: June 17, 2014
• Last Update Posted Date: January 9, 2018
• Study Start Date: April 2012
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2014)

Number of patients with successful sacral neuromodulation [ Time Frame: 2 months ]

success versus failure (yes/no variable)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sacral Neuromodulation for Neurogenic LUT Dysfunction
• Official Title: Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial
• Brief Summary: Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil, St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological assessments, patients who agree will also undergo neurophysiological investigation of the lower urinary tract, i.e. recording of current perception thresholds, sensory evoked potentials, and electroencephalography after stimulation of the urethra and bladder.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Refractory Neurogenic LUTD

Intervention

• Device: Turning OFF the neuromodulator
  Turning OFF the neuromodulator in 50% of the patients in a randomized way by an investigator not involved in the assessment of the clinical outcome during the regular outpatient visit 2 months after neuromodulator implantation. It then follows a 2 months double-blind phase. Thereafter, i.e. during the regular outpatient visit 4 months after neuromodulator implantation, the unblinding takes place and in patients with sacral neuromodulation OFF, the neuromodulator is switched ON.
• Device: Turning ON the neuromodulator

Study Arms

• Active Comparator: sacral neuromodulation ON
  active sacral neuromodulation (neuromodulator ON)
  Intervention: Device: Turning ON the neuromodulator
• Placebo Comparator: sacral neuromodulation OFF
  placebo sacral neuromodulation (neuromodulator OFF)
  Intervention: Device: Turning OFF the neuromodulator

• Publications *: Knupfer SC, Liechti MD, Mordasini L, Abt D, Engeler DS, Wollner J, Pannek J, Kiss B, Burkhard FC, Schneider MP, Miramontes E, Kessels AG, Bachmann LM, Kessler TM. Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction. BMC Urol. 2014 Aug 13;14:65. doi: 10.1186/1471-2490-14-65.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2018): 61
• Original Estimated Enrollment (submitted: June 13, 2014): 60
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Refractory neurogenic LUTD
• Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)
• Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
• Combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
• Stable neurological disease/injury for at least 12 months
• Age minimum 18 years
• Informed consent

Exclusion Criteria:

• Botulinum A toxin injections into the detrusor and/or urethral sphincter in the last 6 months
• Age under 18 years
• Pregnancy
• Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
• No informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02165774
• Other Study ID Numbers: EK 2012 0048
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Zurich
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Zurich
• Original Study Sponsor: Same as current

Collaborators

• University Hospital Inselspital, Berne
• Swiss Paraplegic Centre Nottwil
• Cantonal Hospital of St. Gallen

• Investigators: Not Provided
• PRS Account: University of Zurich
• Verification Date: January 2018