Sacral neuromodulation for the treatment of detrusor hyperreflexia with impaired contractility (DHIC)

Not Applicable

Completed

• Conditions: Detrusor overactivty and impaired bladder contraction; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616001576415
• Lead Sponsor: Dr Johan Gani

Brief Summary

This is the first report describing the efficacy of SNM for DHIC. SNM is a promising potential treatment option for patients with DHIC, and after medium term follow up, it continues to treat both the DO and IC components of this condition.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Study Completion: 2018-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All patients with urodynamically proven DHIC are included in study.

Exclusion Criteria

Patients with evidence bladder outlet (BOO), pelvic organ prolapse, stress urinary incontinence, and neurogenic bladder are excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients that underwent a stage 2 procedure and had a implantable battery placed will be followed up for improvement in there lower urinary tract symptoms. <br><br>Treatment response will be assessed by nternational Consultation on Incontinence Modular Questionnaire on overactive bladder (ICIQ-OAB), [These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure to assess treatment response. Success will defined as greater than 50% symptom improvement in urgency, urge incontinence, and frequency,];Patients will also examined for improvements in voiding. Median voided volumes, median post void residual volumes (PVR) by clean intermittent catheterization (CIC) will be examined[These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure to assess treatment response. Success will defined as greater than 50% reduction in PVR,]

Secondary Outcome Measures

Name	Time	Method
Patient experience and response to treatment will be patient Global Impression of Improvement (PGI-I).[These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure]