Improving clinical outcomes with lower motor voltage (≤3 V) during stage 1 sacral neuromodulation for interstitial cystitis or bladder pain syndrome.

AIMS: We desire to evaluate whether utilization of ≤3 V (new experimental approach) vs the traditional four or more volts for lead motor response during stage 1 sacral neuromodulation may impart an improvement in voiding and pain parameters. METHODS: An observational, retrospective, double cohort review was conducted of 179 female patients who experienced medically recalcitrant interstitial cystitis (IC) or bladder pain syndrome (BPS) between January 2002 and January 2013. Group A included 105 women with a motor response of ≤3 V; group B was comprised of 65 women with a motor response at ≥4 V for medically recalcitrant IC or BPS. Patients completed a 3-day pre- and postoperative voiding diary, visual analog pain (VAP) scale, pain urgency frequency (PUF), and Patient Global Impression of Improvement (PGI-I) questionnaire. RESULTS: The mean (standard deviation) follow-up in months was 120.1 ± 33.3 in group A and 116.3 ± 29.2 in group B (P < .45). A successful conversion from stage 1 to stage 2 showed statistically significant improvement for group A compared with group B (95.4% vs 73.8% conversion rate; P < .001). The success rate also favored group A, with 87.6% success compared with 66.2% for group B (P < .002). Group A mean postoperative VAP scores improved over group B with 3.3 ± 1.2 compared with 5.0 ± 0.8 (P < .001). Group A mean postoperative PUF scores were 10.2 ± 2.7 and group B 14.7 ± 3.5, (P < .001). CONCLUSIONS: In the ≤3 V patient cohort, a compelling, significant statistical improvement was noted in most clinical voiding parameters, including the VAP, PGI-I, and performance questionnaires.

Improving clinical outcomes for women with overactive bladder or urinary retention symptoms: a comparison of motor response voltages (1-9 V) during Stage 1 sacral neuromodulation.

OBJECTIVE: To assess whether the utilisation of a motor response of <3 V during Stage 1 sacral neuromodulation (SNM) results in better clinical outcomes compared to >4 V in patients with overactive bladder (OAB) or urinary retention symptoms. PATIENTS AND METHODS: An observational, retrospective, double cohort review was conducted of 339 female patients who had experienced medically recalcitrant OAB or urinary retention symptoms. Between September 2001 and September 2014, both cohorts underwent successful Stage 1 to Stage 2 SNM placement. Group A, included 174 women with a motor response at ≤3 V; and Group B, evaluated 110 women with a motor response at ≥4 V for medically recalcitrant OAB. Group C, compared 33 women with a motor response at ≤3 V; and Group D, documented 22 women with a motor response at ≥4 V for non-obstructive urinary retention. Patients completed 3-day voiding diaries, the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Patient Global Impression of Improvement Questionnaire. RESULTS: The mean (sd) follow-up was 116.3 (30.3) months in Group A and 112 (34.6) months in Group B (P < 0.354); 150.5 (20.4) months in Group C and 145.8 (17.2) months in Group D (P < 0.38). Successful conversion of Stage 1 to Stage 2 showed statistically significant improvement for both <3-V groups (Groups A and C). Group A had a 93.5% (174/186) conversion rate vs 72.3% (110/152) in Group B for OAB symptoms (P < 0.001). Group C had a 94% (34/36) conversion rate vs 70% (21/30) in Group D (P < 0.017). Defined as a ≥50% reduction in frequency, urgency, urgency incontinence and nocturia, and UDI-6 and IIQ-7 scores, the success rate for Group A was 82.1% (143/174) and for Group B was 63% (69/110) (P < 0.001). The mean battery life improved in both <3-V cohorts (P < 0.001). Annual reprogramming sessions were reduced in Group A and Group C (P < 0.001). Subset analysis of variance showed no statistical improvement in most patient outcomes when 1-V subjects were compared to 2- and 3-V cohorts. However, 32% of 1-V patients (P < 0.001) noted the onset of severe pelvic/perirectal pain and big toe plantar flexion movement with small increments in voltage (0.1-0.2 V) during reprogramming. Only 7% of 2-V and 1% of 3-V patients experienced this complication. CONCLUSIONS: Significant improvement was noted (up to 40%) in most clinical voiding parameters in the <3-V patients for both OAB and urinary retention. While <3 V will still statistically improve patient outcomes, a voltage <2 V may elicit self-reprogramming pain with severe bellows and plantar flexion movement, which may discourage patients from therapy adjustments. We recommend randomised, controlled trials to confirm these results.

Transvaginal rectocele repair with human dermal allograft interposition and bilateral sacrospinous fixation with a minimum eight-year follow-up.

BACKGROUND: Human dermal allografts have been used for over a decade for interpositional repair of rectoceles. How do dermal allografts perform with regards to success rate and complications with 8 years' minimum follow-up? METHODS: We retrospectively reviewed 41 consecutive patients undergoing dermal allograft interposition procedures between October 2001 and December 2005 (Repliform, Boston Scientific, Natick, MA, USA) for stage two, three, and four International Continence Society (ICS) symptomatic rectocele repairs with bilateral sacrospinous fixation. Failure was defined as recurrent stage two International Continence Society prolapse (Ap ≥ -1 and/or Bp ≥ -1). All questionnaires were completed 1 week before surgery and at follow-up (September 2014 through December 2014). RESULTS: The mean preoperative and postoperative A(p) were 0.95 ± 0.70,-1.90 ± 0.52 and B(p) 1.30 ± 0.84,-2.13 ± 0.51 (p < 0.001). With a mean follow-up of 116.5 ± 18.9 months, a success rate of 73 % (30/41) was achieved, with anatomical reduction of prolapse. For splinting and digitations, an 82 % cure rate was realized. The Pelvic Floor Distress Inventory (PFDI) pre- and post-operative results showed significant improvement (p < 0.001). There were two incisional exposures (5 %). Seventy percent of patients were secondary repairs while 30 % were primary repairs (81 % success rate, p < 0.36). One patient experienced nerve entrapment and subsequent unilateral takedown. Patient satisfaction was 77 %. CONCLUSIONS: Our retrospective study approaching long-term results demonstrated that symptomatic rectocele procedures with human dermal allograft interposition provide an effective anatomical and functional repair with acceptable complication rates.

Spleen injury following left extracorporeal shockwave lithotripsy (ESWL).

BACKGROUND: A splenic rupture associated with extracorporeal shockwave lithotripsy (ESWL) is exceedingly rare. We report a case of stage 3 splenic laceration, hemoperitoneum and subsequent splenic rupture following an ESWL for a left mid polar renal calculus. CASE PRESENTATION: During the ESWL, although the patient's pain was controlled the gentleman was very nervous and had to be repositioned eight individual times. Approximately 6 hours after the ESWL, the patient phoned the urologist complaining of severe left flank pain unlike any previous episode of renal colic. A computerized tomography (CT) scan demonstrated a stage 3 splenic injury with hemoperitoneum. The patient decompensated and an emergent splenectomy was then performed and the patient experienced an uneventful recovery. CONCLUSIONS: Splenic injury likely results from unintentional movement during the sound wave administration for the stone fragmentation procedure. Utilizing noise cancelling headphones during ESWL may preclude the potential pitfalls of patient nervousness.

Successful bilateral pudendal neuromodulation to treat male detrusor areflexia following severe pubic symphysis fracture, a case report.

BACKGROUND: A Drum Dock Manager in an auto manufacturing company suffers a pelvic fracture, severing the bulbar urethra and completely fracturing the right side of his pelvis. He is unable to void without catheterization but has a complete sensation to void. Can neuromodulation help him achieve spontaneous voiding? CASE PRESENTATION: We reviewed the electronic medical record of Mr. M.E. from Detroit Medical Center following his 2012 forklift accident and subsequent orthopedic surgeries. He successfully underwent bilateral sacral neuromodulation, with a resulting max flow of 16.8 mls/sec and post-void residual urine of 50-100 mls. Unfortunately, he later presented with bilateral pocket and sacral lead infection, and both systems had to be removed. Six weeks later, M.E. had bilateral pudendal neurostimulation placement to avoid the previously infected areas. Max flow improved to 14.5 mls/sec and 0-50 mls residual urine. However, urodynamics proved that his Pdet at max flow was in excess of 120 cm of H20 pressure while he had been on finesteride and tamsulosin for the preceding five years for the management of his documented benign prostate hyperplasia symptoms. He underwent Green light laser transurethral resection of the prostate and had max flow improvement to 22.5 mls/second with zero residual urine with multiple straight catheterization confirmations. CONCLUSION: Sacral neuromodulation may successfully correct traumatic urinary retention in male patients. Additionally, pudendal neuromodulation can be successfully utilized as a salvage method for an infected sacral neuromodulation impulse generator (IPG) and tined lead with a return to proper voiding.

Neuromodulation for Overactive Bladder Symptoms in Women Utilizing Either Motor or Sensory/Motor Provocation With a Minimum Nine-Year Follow-Up.

INTRODUCTION: This study is an evaluation of whether motor provocation compared to mixed sensory/motor provocation for tined lead placement affects its efficacy with quality of life measurements and Likert patient satisfaction. MATERIALS AND METHODS: An observational, retrospective cohort study was conducted with the analysis of 128 charts of adult women who, between January 2002 and September 2005, underwent a two-staged approach for sacral neuromodulation by the lead author SPM. Both groups did not differ statistically in their mean preoperative American Anesthesiologist Status Classification Score's of two or less, or frequency, urgency, urgency incontinence daily episodes or Urinary Distress Inventory scores. A seven-point Likert Scale was utilized for post-operative patient satisfaction. Sixty-eight patients (Group 1) received pure motor provocation for tined lead placement under general anesthetic and 60 patients (Group 2) received mixed sensory/motor provocation tined lead placement under intravenous sedation and local anesthetic. RESULTS: Sixty-two of 68 (91%) patients in Group 1 proceeded to Stage Two while 53/60 (88%) in Group 2 proceeded to Stage Two implantation (p = 0.28). Median follow-ups were 124.7 ± 21.5 months for Group 1 and 120.4 ± 19.7 months for Group 2 (p = 0.45). Mean preoperative/postoperative Urinary Distress Inventory short form and number of voids per 24 hours were for Group 1, 15.5 ± 6.6/8.9 ± 4.3 and 16.3 ± 5.3/9.2 ± 3.9 and for Group 2, 16.3 ± 6.4/8.4 ± 3.9 and 17.82 ± 7.17/8.34 ± 4.26 voids/24 hours (p < 0.001). Mean preoperative and postoperative ultrasound post void residual urines were 62.2 ± 29.3 milliliters/46.9 ± 20.6 milliliters (Group 1) and 68.0 ± 26.8 milliliters /42.0 ± 27.8 milliliters (Group 2) (p < 0.01). Mean operative times were 29.5 ± 16.8 minutes (Group 1) and 59.3 ± 25.8 minutes (Group 2) (p < 0.001). Mean Likert patient satisfaction score (1, 2, 3) for Group 1 was 2.6 and 1.8 for Group 2 (p < 0.21). The mean numbers of office visits/year for reprogramming were 1.4 ± 0.7 (Group 1) and 2.8 ± 1.1 (Group 2) (p < 0.001). CONCLUSION: Women with mixed sensory/motor provocation tined lead placement incurred statistically significant longer operating room times and an increased number of annual reprogramming sessions. Singular motor provocation tined lead placement may, in fact, improve outcomes by significantly decreasing operating room time, improving patient satisfaction, and decreasing mean yearly reprogramming sessions, compared to mixed sensory/motor tined lead placement.

Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: Interstitial cystitis is a multifaceted medical condition consisting of pelvic pain, urgency, and frequency. Can sacral neuromodulation be successfully utilized for the medium term of ≥ 6 years in interstitial cystitis patients for whom standard drug therapies have failed? METHODS: In our observational, retrospective, case-controlled review (January 2002-March 2004), we sought to discern whether neuromodulation could be successfully implemented with acceptable morbidity rates in interstitial cystitis patients. Thirty-four female patients underwent stage 1 and 2 InterStim placements under a general anesthetic. Simple means and medians were analyzed. RESULTS: Mean pre-op/post-op pelvic pain and urgency/frequency scores were 21.61 ± 8.6/9.22 ± 6.6 (p < 0.01), and mean pre-op/post-op visual analog pain scale (VAPS) were 6.5 ± 2.9/2.4 ± 1.1 (p < 0.01). Median age was 41 ± 14.8 years with a mean follow-up of 86 ± 9.8 months. CONCLUSIONS: With a minimum 6-year follow-up we determined that sacral neuromodulation provides adequate improvement for the symptoms of recalcitrant interstitial cystitis.

Transverse myelitis with urinary retention and clean, intermittent catheterization treated with neuromodulation.

OBJECTIVE: Transverse myelitis is a chronic, debilitating neurologic disease with numerous urological manifestations, including urinary detrusor overactivity, detrusor sphincter dyssynergia and urinary retention. We review our results with sacral neuromodulation for urinary retention in female patients with transverse myelitis. STUDY DESIGN: A retrospective, observational study was conducted among female patients with transverse myelitis and urinary retention hospitalized between January 2002 and January 2009. Five of seven consecutive women underwent Stage 1 and 2 sacral neuromodulation under general anesthesia. RESULTS: Four ambulatory patients (57%) were successfully implanted, while three nonambulatory patients did not achieve implantation, with a mean follow-up of 3.87 +/- 2.11 years and mean postoperative postvoid residual of 72.5 +/- 45.6 mL (p < 0.001). Postoperative uroflowmetry revealed a mean maximum uroflow of 16.7 +/- 5.9 mL/sec (preoperative max flow was 0.0 mL/sec) (p < 0.001). Two implanted patients required revisional surgeries for lead migration and increased impedance. CONCLUSION: Ambulatory female patients with transverse myelitis and urinary retention may be successfully treated with sacral neuromodulation. Insignificant improvements in postvoid residual urine/maximum uroflow were attained with nonambulatory and assisted ambulatory patients.

Sacral neuromodulation for multiple sclerosis patients with urinary retention and clean intermittent catheterization.

INTRODUCTION AND HYPOTHESIS: Multiple sclerosis is a chronic, debilitating, neurological disease with numerous urological manifestations including urinary detrusor overactivity, detrusor sphincter dyssynergia, and urinary retention. Can sacral neuromodulation be successfully implemented for urinary retention in ambulatory women with multiple sclerosis? METHODS: Between January 2002 and January 2008, we conducted an observational retrospective case-control study where 12 of 14 consecutive, ambulatory women with multiple sclerosis had stage 1/2 sacral neuromodulation performed under general anesthesia for urinary retention. RESULTS: Twelve of 14 patients (86%) were successfully implanted, with a mean follow-up of 4.32 +/- 1.32 years and mean postvoid residual of 50.5 +/- 21.18 ml. The mean maximum uroflow was 17.7 +/- 7.9 ml/s. Two of the 12 patients (17%) required revisional surgeries for lead migration, and 40% needed battery replacement. CONCLUSION: Urinary retention in multiple sclerosis female patients can be successfully and safely managed with sacral neuromodulation with few complications with a mean of 4 years follow-up.

New technologies in the management of overactive bladder: current research and future prospects.

Overactive bladder is characterized by frequency, urgency (wet or dry) and nocturia. These troublesome symptoms incur both a physiologic and economic cost, expected to be in excess of US$82 billion in the USA and Europe by the year 2020. Second-tier medicinal oral therapies for overactive bladder abound, but the failure rate or discontinuation at 1 year exceeds 50%. Tertiary-tier therapies involve surgical alternatives including neuromodulation of sacral nerve 3 (S3) or the posterior tibial nerve as a means to manipulate and ameliorate the above-described voiding symptoms. Sacral neuromodulation has been studied for more than 20 years, but newer, smaller, rechargeable implantable devices are in the forefront of current investigation. Hopes are that modifications to the device will eventually be possible at the patient's home, rather than the physician's office, with close urological/gynecologic supervision and guidance. Another means of surgical intervention for overactive bladder includes the use of a cystoscopy-guided radiofrequency probe by which energy disrupts the bladder floor neural voiding plexi. Stem cell therapy is also being evaluated for overactive bladder but is in the early stages of development.

Will hysterectomy at the time of sacrocolpopexy increase the rate of polypropylene mesh erosion?

Will total abdominal hysterectomy with concomitant sacrocolpopexy lead to polypropylene (Prolene, Ethicon, Somerset, NJ) mesh erosions? Sixty-seven patients demonstrating a stage 2 or more International Continence Society cystocele, rectocele, and uterine prolapse underwent combined sacrocolpopexy and polypropylene mesh fixation and total abdominal hysterectomy. Surgical failure was noted as prolapse of any of the three pelvic compartments with a stage 2 or more recurrence. Sixty-four patients were available for examination, and none demonstrated mesh erosion or recurrent vault prolapse with a median follow-up of 27 months. Four patients experienced a recurrent stage 2 rectocele without any cystoceles or vault prolapse. Performing abdominal hysterectomy with concomitant sacrocolpopexy with polypropylene extensions does not increase the occurrence of synthetic material erosions in the vaginal vault or the anterior or posterior vaginal walls.

Effects of sacral neuromodulation on female sexual function.

The aim of this prospective study was to determine if sacral neuromodulation has an effect on the patient's subsequent sexual function. Sexually active patients that underwent an Interstim Sacroneuromodulator implantation (Medtronic, Minneapolis, MN) for control of bladder symptoms were enrolled. A Female Sexual Function Index (FSFI) was completed before surgery and at a mean of 5.7 months postoperatively. Eleven subjects proceeded to permanent implantation, seven of these were sexually active before and after placement. Three subjects (43%) felt the device impacted on their sexual function in a positive way (1) by decreasing urgency and (2) by increasing desire. Overall sexual frequency increased significantly after the surgery (p=0.047). There were also significant increases in the FSFI total (p=0.002), and domain scores for desire (p=0.004), lubrication (p=0.005), orgasm (p=0.043), satisfaction (p=0.007), and pain (p=0.015). There was no correlation between patient report of urinary symptom improvement and FSFI scores. In conclusion, sacral neuromodulation may improve sexual frequency and sexual function scores in subjects with urgency frequency and urge incontinence.

Incontinence and voiding difficulties associated with prolapse.

PURPOSE: Prolapse is the protrusion of a pelvic organ beyond its normal anatomical confines. It represents the failure of fibromuscular supports. MATERIALS AND METHODS: A MEDLINE search was done using the keywords cystocele, uterine prolapse, vault prolapse, enterocele or rectocele in combination with urinary incontinence. We reviewed 97 articles. From this material the definition, classification, incidence, symptoms and evaluation are described. RESULTS: Prolapse and urinary incontinence often occur concomitantly and cystocele, rectocele, enterocele, uterine descent or vaginal vault prolapse may also be present. The pathophysiology of prolapse encompasses direct and indirect injury, metabolic abnormalities and chronic high intra-abdominal pressure. Anterior vaginal wall prolapse may present as stress incontinence. A large cystocele may cause urethral kinking and overflow incontinence. Uterine descent can cause lower back and sacral pain. Enterocele may cause only vague symptoms of vaginal discomfort. A rectocele can lead to incomplete evacuation of stool. A thorough history and physical examination are the most important means of assessment. A voiding diary helps determine functional bladder capacity. Uroflow examination determines the average and maximum flow rates, and the shape of the curve can help identify Valsalva augmented voiding. Multichannel urodynamics or video-urodynamics with prolapse reduced can be important. The advantages of dynamic magnetic resonance imaging include excellent depiction of the soft tissues and pelvic organs, and their fluid content during various degrees of pelvic strain. To our knowledge whether it is cost-effective in this manner has not been determined. CONCLUSIONS: Correction of prolapse must aim to restore vaginal function and any concomitant urinary incontinence.