Clinical trial NCT01130415: Screening Method in Sacral Neuromodulation
Official title: Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Urinary Retention
Keywords: Sacral neuromodulation
Screening
Percutaneous nerve evaluation
Tined lead
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Scientific Foundation Urology Maastricht
First posted: 2010-05-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been treated with sacral neuromodulation in our centre between 2002 and 2009

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).

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 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

Primary outcomes:
measure: long-term success measured with voiding diaries
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Philip van Kerrebroeck, Prof
role: STUDY_DIRECTOR
References: