Screening Method in Sacral Neuromodulation

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130415
• Other study ID #: 1234
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: May 25, 2010
• Start date: May 2002
• Est. completion date: July 2009

Study information

• Verified date: May 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: De Voedsel en Waren Autoriteit
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Retention

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Scientific Foundation Urology Maastricht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No