Screening Method in Sacral Neuromodulation

This study has been completed.
Sponsor:
Collaborator:
Scientific Foundation Urology Maastricht
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01130415
First received: May 19, 2010
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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).


Condition
Overactive Bladder
Urinary Retention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • long-term success measured with voiding diaries [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Successful treatment was defined as more than 50 percent improvement in the key voiding diary variables compared to baseline.


Enrollment: 64
Study Start Date: May 2002
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated with sacral neuromodulation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01130415

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Scientific Foundation Urology Maastricht
Investigators
Study Director: Philip van Kerrebroeck, Prof Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: P. van Kerrebroeck, Maastricht University Medical Centre
ClinicalTrials.gov Identifier: NCT01130415     History of Changes
Other Study ID Numbers: 1234
Study First Received: May 19, 2010
Last Updated: May 25, 2010
Health Authority: The Netherlands: De Voedsel en Waren Autoriteit

Keywords provided by Maastricht University Medical Center:
Sacral neuromodulation
Screening
Percutaneous nerve evaluation
Tined lead

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Retention
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014