Screening Method in Sacral Neuromodulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01130415
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Scientific Foundation Urology Maastricht
Information provided by:
Maastricht University Medical Center

Brief Summary:
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 or disease
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
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?
Study Start Date : May 2002
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2009

Patients treated with sacral neuromodulation

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01130415

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

Responsible Party: P. van Kerrebroeck, Maastricht University Medical Centre Identifier: NCT01130415     History of Changes
Other Study ID Numbers: 1234
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010

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

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