Sacral neuromodulation for intractable urge incontinence: Are there factors associated with cure?

125

Aim: The purpose of this study was to review our institution's 11-year experience with SNS for the treatment of refractory voiding dysfunction. Dating back to 1993, it covers a span of time which describes the evolution of SNS as it includes PNE trials, non-tined (bone-anchored or fascial-anchored) leads, percutaneous tined leads with two-staged procedures, and even percutaneous pudendal trials. Methods: A retrospective review was performed on SNS patients who received an implantable pulse generator (IPG) in our practice from 12/1993 to 12/2004. After Institutional Review Board approval, consents for chart review were obtained from 104 patients, representing 44% of this neuromodulatory patient population. Results: Of our population, 87% were female and 13% were male. Average age at implant was 50 years AE 13.4 years. Duration of symptoms before implantation was 116 months (range 9^600 months). Eighty percent were implanted for a predominant complaint of urinary urgency and frequency (U/F). Overall, 22% had U/F only, 38% had concomitant urge incontinence (UI), and 20% had concomitant mixed incontinence (MI). Twenty percent were treated for non-obstructive urinary retention (UR), with half of these associated with a neurogenic etiology. Additionally, 46.2% had pelvic pain, 58.6% had bowel complaints, and 51% reported sexual dysfunction. In patients with U/F, mean voiding parameters as described by pre-implant voiding diaries revealed the following: 12.4 (AE5.1) voids per 24 hr; 2.3 (AE1.8) voids per night; 5.0 (AE4.7) leaks per 24 hr; and 2.3 (AE2.6) pads per 24 hr. Statistically signi¢cant improvements post-implantation were noted with mean decreases in the following: 4.3 voids per 24 hr; 1.0 void per night; 4.4 leaks per 24 hr; and 2.3 pads per 24 hr (all P < 0.05). In the UR group a statistically signi¢cant improvement post-implantation was noted only in voids per night, with a mean decrease of 0.8 (P < 0.05). With a mean follow up of 22 months (range 3^162 months), sustained subjective improvement was >50%, >80%, and >90% in 69%, 50%, and 35% of patients, respectively. By quality of life survey, 60.5% of patients were satis¢ed and 16.1% were dissatis¢ed with current urinary symptoms. Only 13% (14 patients) abandoned therapy, making up a signi¢cant portion of those dissatis¢ed with current urinary symptoms. Good overall lead durability was seen (mean 22 months, range 1^121 months), with the ¢rst successful lead proving to be the most durable (mean 28 months, range 1.41 20 months). Lead durability decreased progressively with subsequent trials. Overall, 53% of patients experienced at least one reportable event (RE) attributable to either lead or IPG. A total of 126 REs were noted, with 97% mild-to-moderate in severity. REs included lack of e⁄cacy, loss of e⁄cacy, infection, hematoma/seroma, migration, pain, undesirable change in sensation, and device malfunction. In this population, 47.1% of leads were tined while 52.9% were non-tined. Tined leads had an overall lower RE rate as compared to non-tined leads: 28% ...

Section: Discussioncontrasting

confidence: 76%

Sacral nerve stimulation for voiding dysfunction: One institution's 11‐year experience

Sutherland

Lavers

Carlson³

et al. 2006

125

“…Therefore, the reduction in 24-hr pad weight after intervention would be expected to be equally sound since the basis of the test remains the same. The reduction in 24-hr pad weight has already been used as a means to evaluate incontinence treatment outcomes [Flynn et al, 2004;Amundsen et al, 2005]. Our data clearly show a signi¢cant reduction in the mean post-operative 24-hr pad weight of À274 g (P < 0.001) after the male sling procedure.…”

Section: Discussionsupporting

confidence: 51%

Comparison between reduction in 24‐hour pad weight, International Consultation on Incontinence‐Short Form (ICIQ‐SF) score, International Prostate Symptom Score (IPSS), and Post‐Operative Patient Global Impression of Improvement (PGI‐I) score in patient evaluation after male perineal sling

Twiss

Fischer

Νitti

2006

Aims:We assessed the utility of three self-assessment instruments: the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the post-operative Patient Global Impression of Improvement (PGI-I) score, and the International Prostate Symptom Score (IPSS) by correlating them with an objective outcome, the change in 24-hr pad weight, after a male perineal sling. Methods: Twenty-six men with urodynamically con¢rmed stress incontinence underwent a male perineal sling. Patients were evaluated pre-operatively and post-operatively with a 24-hr pad test, IPSS and ICIQ-SF. Patients also completed the PGI-I post-operatively. Changes in study parameters were compared via the paired t-test, and correlations were performed using Spearman's rho. Results: There were signi¢cant reductions in 24-hr pad weight (À274 g, P < 0.001), percentage 24-hr pad weight (54.2%), ICIQ-SF score (À6.3, P < 0.001), and the three ICIQ-SF subscores (À1.2, À1.7, À3.4 for Questions 3, 4, and 5, respectively, P < 0.001 for all). The change in total ICIQ-SF score and the post-operative PGI-I score correlated strongly with percentage reduction in 24-hr pad weight (r ¼ À0.68, P < 0.001; r ¼ À0.81, P < 0.001, respectively) and with each other (r ¼ 0.79, P < 0.001). The change in all three ICIQ-SF subscores correlated signi¢cantly with percentage reduction in 24-hr pad weight and with post-operative PGI-I score. There was no signi¢cant change in the IPSS or the voiding or storage subscores, and none correlated with any other study parameter. Conclusions: This study validates the construct validity of the ICIQ-SF and PGI-I in the assessment of treatment for male stress incontinence and should make clinicians con¢dent in comparing studies of incontinence treatment utilizing the change ICIQ-SF score, the post-operative PGI-I score, and percentage reduction in 24-hr pad weight as outcome measures.

“…While most studies have not found urodynamic measurements to be predictive of success with SNS, several studies have shown that advanced age and longer symptom duration were associated with failure to respond to SNS [Scheepens et al, 2002a;Amundsen et al, 2005]. Although the majority of our patients (84%) had objective evidence of detrusor overactivity on ¢lling cystometrogram, there were no signi¢cant di¡erences between responders and non-responders to sacral neuromodulation with respect to a number of other Neurourology and Urodynamics DOI 10.1002/nau urodynamic parameters.…”

Section: Discussionmentioning

confidence: 58%

Management of refractory urinary urge incontinence following urogynecological surgery with sacral neuromodulation

Starkman

Wolter

Scarpero

et al. 2006

Aims: We sought to explore our patient outcomes utilizing sacral neuromodulation in the management of refractory urinary urge incontinence following urogynecological surgical procedures. Methods: A total of 25 women with urinary urge incontinence following urogynecological surgery were selected for SNS therapy and retrospectively analyzed. All patients completed a comprehensive urological evaluation. Clinical data was recorded to determine outcomes and identify parameters that would be predictive of response to neuromodulation. Outcomes were determined via subjective patient questionnaire and graded as follows: signi¢cant response (80% improvement), moderate response (50% and <80% improvement), and poor response (<50% response). Results: Nineteen patients had a previous pubovaginal sling (10 with concomitant pelvic prolapse repair), 3 a previous retropubic suspension, and 3 a transperitoneal vesicovaginal ¢stula repair. Urethrolysis was performed in 4 patients to alleviate bladder outlet obstruction prior to sacral neuromodulation. Mean patient age was 59.8 years and length of follow-up was 7.2 months. Twenty-two women (88%) had the IPG placed during a Stage 2 procedure. Twenty patients maintained at least a 50% improvement in clinical symptoms at last follow-up and 6 patients were continent. Overall, the number of pads/day improved from 4.2 to 1.1 (P < 0.001). There were no signi¢cant di¡erences in response to neuromodulation based upon age, duration of symptoms, type of surgery, or urodynamic parameters. Conclusion: Sacral neuromodulation appears to be an e¡ec-tive therapy in patients with refractory urge incontinence following urogynecological surgery. Larger prospective studies with longer follow-up are needed to assess the durability of this therapeutic modality. Neurourol. Urodynam. 26: 29^35, 2007. ß 2006