Screening Method in Sacral Neuromodulation

Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?

The purpose of this study was to evaluate whether there is a difference in long-term outcome between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined lead procedure (TLP).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Retention

Detailed Description

Purpose: To evaluate if there is a difference in long-term outcome of sacral neuromodulation (SNM) between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined lead procedure (TLP). Furthermore, we wanted to evaluate the outcome in patients who only responded to screening with TLP after failure of initial PNE.

Materials and methods: We evaluated all patients screened for eligibility to receive SNM treatment since the introduction of the tined lead technique in our centre in 2002. In May 2009, all implanted patients were asked to keep a voiding diary to record the effect of SNM on urinary symptoms. Success was defined as more than 50% improvement in at least one of the relevant voiding diary parameters compared to baseline. Chi square analysis was used to evaluate differences in long-term outcome for the separate screening methods.

Results: In total, 92 patients were screened for SNM. Of the 76 patients who were screened with PNE, 35 (46%) met the criteria for permanent implantation, whereas 11 of the 16 patients (69%) who underwent direct screening with TLP had permanent stimulators placed. Of the 41 patients who failed PNE and subsequently underwent screening with TLP, 18 (44%) were implanted with an INS after showing a successful response. The mean follow-up was 53 months (range 35-77 months) at the time of voiding diary analysis. Statistical analysis showed no difference between type of screening and long-term success (p=0.94).

Conclusion: Although first stage TLP is a more reliable screening tool than PNE, the long-term success rate does not seem to be dependent on the screening method. Furthermore, patients who initially failed PNE but responded to prolonged screening with TLP, appear to be at least as successful in the long-term as patients who directly responded to PNE or TLP.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ
      • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been treated with sacral neuromodulation in our centre between 2002 and 2009

Description

Inclusion Criteria:

• patients who have been treated for overactive bladder syndrome or chronic non-obstructive urinary retention with sacral neuromodulation by using the tined lead

Exclusion Criteria:

• patients with bilateral implantation of a tined lead
• patients who have been treated with sacral neuromodulation for pelvic pain

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients treated with sacral neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term success measured with voiding diaries	Successful treatment was defined as more than 50 percent improvement in the key voiding diary variables compared to baseline.	5 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Scientific Foundation Urology Maastricht
• Investigators: Study Director: Philip van Kerrebroeck, Prof, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (ESTIMATE): May 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 25, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Screening; Percutaneous nerve evaluation; Sacral neuromodulation; Tined lead
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Retention
• Other Study ID Numbers: 1234 (Department of Defense)