Direct Full-stage Implantation of Sacral Neuromodulation

Withdrawn

• Conditions: Urinary Bladder, Overactive; Urge Incontinence
• Interventions: Device: full stage implantation of sacral neuromodulation

• Registration Number: NCT03697954
• Lead Sponsor: Loma Linda University

Brief Summary

The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Study Start: 2021-05
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients >18 years of age
• Female gender
• Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents
• Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative)
• Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments
• Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery
• Health insurance provider that will cover full-stage implantation

Exclusion Criteria

• Age <18
• Pregnant or planning to become pregnant
• Male gender
• Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period
• Treatment with botulinum toxin within last 6 months
• Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months
• Severe pelvic organ prolapse
• Post-void residual >150 ml
• Symptomatic or recurrent urinary tract infection
• Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy
• Cognitive disorders, e.g. dementia
• Interstitial cystitis or chronic pelvic pain syndrome
• Poorly controlled diabetes mellitus (HbA1c >10%)
• History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization
• Anticipated or known need for MRI at the trunk
• History of or anticipated surgery at the lower back
• Unable to hold antiplatelet or anticoagulation prior to surgery
• Life expectancy <1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
overactive bladder patients	full stage implantation of sacral neuromodulation	Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation

Primary Outcome Measures

Name	Time	Method
Improvement in overactive bladder symptoms	1 year	measured using overactive bladder questionnaire

Trial Locations

Locations (1)

Loma Linda University Faculty Medical Offices; 🇺🇸 Loma Linda, California, United States