Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study.

PURPOSE: We report the long-term efficacy and safety of percutaneous tibial nerve stimulation with the Urgent® PC Neuromodulation System for overactive bladder after 3 years of therapy. MATERIALS AND METHODS: Fifty participants in the randomized, double-blind SUmiT (Sham Effectiveness in Treatment of Overactive Bladder Symptoms) Trial who met the primary effectiveness end point after 12 weekly percutaneous tibial nerve stimulation treatments were enrolled in this prospective study to assess long-term outcomes with percutaneous tibial nerve stimulation. STEP (Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation) Study patients were prescribed a fixed schedule 14-week tapering protocol followed by a personal treatment plan aimed at sustaining overactive bladder symptom improvement. Overactive bladder and quality of life questionnaires were completed every 3 months and 3-day voiding diaries were completed every 6 months. RESULTS: A total of 29 patients completed the 36-month protocol and received a median of 1.1 treatments per month after a 14-week treatment tapering protocol. A Bayesian model estimated that 77% (95% CI 64-90) of patients maintained moderate or marked improvement in overactive bladder symptoms at 3 years. Compared to baseline, median voids per day decreased from 12.0 (IQR 10.3-13.7) to 8.7 (IQR 7.3-11.3), nighttime voids per night decreased from 2.7 (IQR 1.7-3.3) to 1.7 (IQR 1.0-2.7) and urge incontinence episodes per day decreased from 3.3 (IQR 0.7-6.0) to 0.3 (IQR 0.0-1.0) (all p <0.0001). All quality of life parameters remained markedly improved from baseline through 3 years (all p <0.0001). One patient experienced 2 mild treatment related adverse events of bleeding at the needle site during followup. CONCLUSIONS: Most STEP participants with an initial positive response to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month.

Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study.

AIMS: To evaluate the safety, sustained effectiveness, and treatment interval for percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) therapy through 24 months. METHODS: A prospective study following treatment success after 12 weekly PTNS treatments, subjects were prescribed a 14-week tapering protocol, followed by ongoing therapy with a Personal Treatment Plan determined by the investigator and subject to sustain subject OAB symptom improvement. Questionnaires were completed every 3 months, voiding diaries every 6 months; adverse events were reported throughout. RESULTS: Of 50 subjects enrolled, 35 remained in the study at 24 months. During the 24 months following initial treatment success and a 14-week tapering protocol, mean treatments per month was 1.3. Voiding diary and OAB-q data demonstrate sustained improvement reported at 13 weeks through 24 months. Improvements in frequency, urge incontinence episodes, night-time voids and moderate-to-severe urgency episodes from voiding diaries at 6, 12, 18, and 24 months were statistically significant compared to baseline (prior to initial 12 weekly treatments). Compared to baseline, OAB-q symptom severity scores and health related quality of life scores were statistically significant for improvement at each tested time point. Five mild adverse events of unknown relation to treatment were reported. CONCLUSION: Sustained safety and efficacy of PTNS were demonstrated over 24 months with initial success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a Personalized Treatment Plan. With an average of 1.3 treatments per month, PTNS therapy is a safe, durable, and valuable long-term OAB treatment option to sustain clinically significant OAB symptom control.

Vaginal diazepam use with urogenital pain/pelvic floor dysfunction: serum diazepam levels and efficacy data.

Vaginal diazepam is used off-label for pelvic floor dysfunction and urogenital pain, but serum levels with efficacy have not been reported until now. One clinician evaluated 21 women for overall, levator, and vulvar pain pre- and one-month post-daily diazepam treatment. One-month post-treatment assessments and serum diazepam levels were done; 62% were moderately or markedly improved. Levator examination pain scores were significantly improved, and vulvar pain scores decreased post-treatment. Serum diazepam levels were within normal limits. Vaginal diazepam may be helpful in treating pelvic floor/urogenital pain conditions.

Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial.

PURPOSE: The Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy. The improvement in global response assessment, voiding diary parameters, and overactive bladder and quality of life questionnaires was evaluated. MATERIALS AND METHODS: A total of 220 adults with overactive bladder symptoms were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder and quality of life questionnaires as well as 3-day voiding diaries were completed at baseline and at 13 weeks. Subject global response assessments were completed at week 13. RESULTS: The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p <0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported. CONCLUSIONS: This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.

The relationship of interstitial cystitis/painful bladder syndrome to vulvodynia.

INTRODUCTION: Many patients have interstitial cystitis/painful bladder syndrome (IC/PBS), a condition of frequency, urgency, and pain affecting more than 1 million women in the United States. The vulva, not the urethra or bladder, may actually be the site of some of the reported pain in women with IC/PBS. PURPOSE: The purpose of this study was to identify the presence of vulvodynia in women diagnosed with IC/PBS. METHOD: A mailed survey was used to identify women with IC/PBS who also reported vulvar pain. The survey also identified related factors, such as menstrual/hormonal status, sexual function, abuse, and sequence of vulvar and bladder pain from adolescence to adulthood. RESULTS: Four-hundred-sixteen women with a documented diagnosis of IC/PBS were mailed a survey. The response rate was 49.6%, with 197 completed surveys returned. Results include vulvar pain in adolescence reported by 10.9% of the respondents, while vulvar pain in adulthood was reported by 48.4% of the women. During the last year, 62.7% of the respondents reported vulvar pain. Ninety-five percent (95%) of the women reported having been sexually active in adulthood, but one-third were not currently sexually active; 27% reported fear of pain as the reason. An abuse history was reported by 28.5% of the women. Of the women who were postmenopausal (two-thirds of the group), 38% used hormone replacement therapy. Birth history showed no correlation to vulvar pain. CONCLUSIONS: The chronic pain that IC/PBS patients feel may not be totally related to their bladder, but instead, may be vulvar pain. The incidence of abuse, past pelvic surgeries, pelvic floor dysfunction, and the chronologic sequence of co-morbid symptoms should be further assessed.

Guided imagery for women with interstitial cystitis: results of a prospective, randomized controlled pilot study.

INTRODUCTION: In the United States, more than 1 million women and men are affected with interstitial cystititis (IC), which is a clinical syndrome involving urinary urgency, frequency, and pelvic pain. A review of the literature revealed that there are no studies showing the effect of guided imagery in women with IC. The purpose of this clinical investigation was to explore the effect of guided imagery on pelvic pain and urinary symptoms in women with IC symptoms. METHODOLOGY: Thirty (30) women with diagnosed IC were randomized into 2 equal groups. One group (treatment) listened to a 25-minute guided imagery compact disc (CD), that was created specifically for women with pelvic pain and IC, twice a day for 8 weeks. The control group rested for 25 minutes twice daily for 8 weeks. Because no guided imagery CDs specifically for women with IC were found on the commercial market, the authors created a script and recorded the CD specifically for women with IC and pelvic pain. The focus of this guided imagery CD was on healing the bladder, relaxing the pelvic-floor muscles, and quieting the nerves specifically involved in IC. Baseline and end-of-study assessment questionnaires (Interstitial Cystitis Symptom Index & Problem Index [IC-SIPI], IC Self-Efficacy Scale, a visual analogue [VAS] scale for pain, and a global response assessment [GRA]), 2-day voiding diaries, and 24-hour pain diaries were completed by the subjects and were evaluated using SPSS (Chicago, IL). RESULTS: More than 45% of the treatment group were responders to guided imagery therapy noting a moderate or marked improvement on the GRA. Pain scores and episodes of urgency significantly decreased in the treatment group. Responders had significant reductions in IC-SIPI scores (problem index, p = 0.006; symptom index, p = 0.004). In addition, responders on the GRA had significant (p = 0.039) improvements in mean pain scores from 5.50 to 2.57 at the end of the study in contrast to the nonresponders, whose pain levels remained the same (4.89 to 4.39). CONCLUSIONS: This is the first study providing preliminary data supporting the use of guided imagery as a potential therapy for IC. Guided imagery may be a useful tool to offer women with IC for pain and IC symptom management. It is an intervention without negative side-effects, is readily available, and shows a trend toward improvement of IC symptoms.

Prevalence of self-reported interstitial cystitis (IC) and interstitial-cystitis-like symptoms among adult women in the community.

PURPOSE: Reported estimates of IC prevalence vary widely. The objective of this study is to determine the prevalence of IC among community-dwelling adult women. METHODS: We analyzed survey responses from 215 established IC cases and 823 age-matched community-dwelling controls. Using a history of diagnosis of urinary conditions and presence of pelvic pain within the last six months, we identified those with possible IC among the controls using various operative definitions. RESULTS: The prevalence rates of self-reported IC (SRIC) and IC-like symptoms (ICLS) among controls in the community were 3.7% and 4.4%, respectively. Expanding ICLS by including women who reported pelvic pain only raised the prevalence to 17.3%. CONCLUSIONS: According to our prevalence rates and population estimates in the United States census 2000, the number of adult women who possibly have interstitial cystitis is estimated to be between 422,803 and 21,454,813. Although estimates based on the question of having ever been diagnosed with IC lead to an estimate close to that derived from symptoms, underestimation of IC prevalence might occur in the absence of additional questions and testing to validate and qualify the responses further. There is also a need for clinical studies to verify and validate the diagnoses to enable accurate assessment of the sensitivity and specificity of such history survey questions.

Frequency, urgency, and pelvic pain: treating the pelvic floor versus the epithelium.

For years the bladder epithelium has been the focus for diagnosing and treating the frequency, urgency, and pelvic pain of interstitial cystitis. However, many patients have not found symptom relief with these therapies. Pelvic floor dysfunction is often present in these patients, yet it is often untreated. Pelvic floor dysfunction may be related to abuse, past surgeries, or other causes. It is important to look outside of the bladder and explore other causes and treatments for this condition. Pelvic floor therapies should be a first line of treatment for those women with chronic pelvic pain related to pelvic floor dysfunction.

Does a history of bullying and abuse predict lower urinary tract symptoms, chronic pain, and sexual dysfunction?

PURPOSE: To investigate associations of bullying and abuse with pelvic floor symptoms, urogenital pain, and sexual health characteristics of women presenting to a multidisciplinary women's urology center. METHODS: Retrospective review of a prospective database. Patients completed questions about bullying, abuse, sexual health and validated questionnaires including the Pelvic Floor Dysfunction Inventory (PFDI-20), Overactive Bladder Questionnaire (OAB-q), and visual analog scale (VAS 0-10) for genitourinary pain. Statistical analyses included Chi-squared and t tests, which compared victims of bullying and/or abuse to non-victims. RESULTS: Three hundred and eighty patients were reviewed. Three hundred and thirty-eight had data on bullying and abuse history. Out of 380, 94 (24.7 %) reported that they were victims of bullying. Out of 380, 104 (27.4 %) reported that they were victims of abuse. Women with a history of bullying and abuse had increased overall pain scores compared to those without a history of either. Women with a history of abuse and bullying had increased PFDI-20, POPDI, and UDI-6 scores compared to women who were not bullied or abused. There was no difference in being sexually active or in sexual satisfaction between the groups. Patients with a history of abuse and bullying had the greatest percentage of dyspareunia (p = 0.009). CONCLUSIONS: Women with a history of bullying, abuse, or both predict increased pelvic floor distress, urological symptoms, increased urogenital pain, and increased dyspareunia. Clinicians should screen for exposure to bullying or abuse in order to provide comprehensive resources to address these psychosocial issues.

Characterization of a clinical cohort of 87 women with interstitial cystitis/painful bladder syndrome.

OBJECTIVE: To provide a characterization of a cohort of women with interstitial cystitis/painful bladder syndrome (IC/PBS) by describing their historical and clinical characteristics. This was reported with the National Institutes of Health chronic prostatitis cohort, but a literature review did not reveal a similar study for women with IC/PBS. METHODS: A total of 87 women with IC/PBS were referred to the Beaumont Women's Initiative for Pelvic Pain and Sexual Health program. A certified nurse practitioner took a comprehensive history and performed a pelvic exam for each. Data were analyzed using descriptive statistics to describe this cohort. RESULTS: Most women experienced constant pain for 5 or more years (mean Visual Analog Scale = 5 out of 10). A total of 94.2% had levator pain. More than 50% had vulvar pain with exam. More than half reported a history of abuse, often in more than one life stage. A total of 28% had cesarean births and 76% had a history of miscarriage, stillbirth, or abortion. Women averaged 4 lifetime pelvic surgeries, and 48% had hysterectomies, two-thirds of which were done before IC/PBS diagnosis. Premenstrual women reported pain throughout the menstrual cycle. As many as 12% had chlamydia previously, which was higher than the national average. Common comorbidities were pelvic pain (93%), allergies (86%), and sexual dysfunction (72%). CONCLUSIONS: This population of women with unrelieved chronic pain, frequency, and urgency is in desperate need of care. Researchers should continue to search for the etiology, prevention, and treatment interventions that are effective in dealing with IC/PBS. It may be most therapeutic to develop a multimodal plan of care that includes physical therapy, oral and intravesical therapies, neuromodulation, and cognitive-behavioral therapies.

Dilemmas in diagnosing pelvic pain: multiple pelvic surgeries common in women with interstitial cystitis.

We determined the prevalence of pelvic surgeries in women with interstitial cystitis (IC) compared to community-based controls through responses to a survey from 215 women with IC and 823 controls. Women with IC had a statistically higher prevalence of hysterectomies (cases=42.3%, controls=21.4%), bladder suspensions (cases=21.9%, controls=5.7), pelvic or genital surgeries other than cystoscopy (cases=26.5%, controls=16.2%), and laparoscopic pelvic surgeries (cases=22.8%, controls=8.3%). Women with IC more commonly had been diagnosed with endometriosis (cases=25.6%, controls=9.8%) and fibroids (cases=24.2%, controls= 16.3%). Of women with IC who had hysterectomies, 68% of the hysterectomies were done before their diagnosis of IC, and only 21% were done after their IC diagnosis. The diagnosis of IC occurred 1-5 years after hysterectomy in most cases. Women with IC have significantly more pelvic surgeries than controls. The majority of these surgeries were done before the diagnosis of IC and may be performed for pain related to undiagnosed IC.

Prevalence of pelvic floor dysfunction in patients with interstitial cystitis.

OBJECTIVES: To evaluate the prevalence of pelvic floor dysfunction in women with interstitial cystitis (IC). METHODS: Women with IC and pelvic pain were referred to the Beaumont Women's Initiative for Pelvic Pain and Sexual Health program. A comprehensive patient history and pelvic examination were completed by a certified women's health nurse practitioner. RESULTS: Seventy women with a mean age of 45 years were evaluated. Of these 70 women 87% had levator pain consistent with pelvic floor dysfunction. The mean levator pain score was 4.48 out of 10. Nearly two thirds of these women (64%) had their pain for 5 years or more, whereas one quarter (24%) had their pain for 1 to 3 years. Half of the women reported irritable bowel syndrome, and more than one third (36%) reported urge urinary incontinence. CONCLUSIONS: Women with IC may have pelvic floor dysfunction, as noted in this population in which 87% had levator pain upon examination. If pelvic floor dysfunction is diagnosed in IC patients, then therapy targeting the pelvic floor musculature may be considered as part of a multimodality approach to treating IC.

Fact or fiction--is abuse prevalent in patients with interstitial cystitis? Results from a community survey and clinic population.

PURPOSE: We determined whether abuse is associated with interstitial cystitis by surveying patients with interstitial cystitis and controls. We corroborated this association in a clinic population. MATERIALS AND METHODS: A survey was mailed to 406 women diagnosed with interstitial cystitis and 5,000 age matched, randomly selected women in the United States. Similar data were collected from our interstitial cystitis clinic population by interviews in person. RESULTS: We evaluated surveys from 464 symptom-free controls, 215 established patients with IC and 121 respondents with a history suggestive of interstitial cystitis. A higher proportion of patients with interstitial cystitis reported a history of abuse than controls (37% vs 22%, p <0.001). Sexual, physical and emotional abuse were also reported by a higher proportion of patients with interstitial cystitis. In our clinic population 76 women diagnosed with interstitial cystitis were evaluated, of whom 49% reported a history of abuse. Of those reporting abuse 92% reported emotional abuse, 78% reported physical abuse, 68% reported sexual abuse and 49% reported domestic violence. CONCLUSIONS: Our study demonstrates an association between interstitial cystitis and abuse. Thus, it is important for clinicians to assess for abuse in women with interstitial cystitis or pelvic pain and provide appropriate referral to psychologists or other health care workers to provide comprehensive care for managing their symptoms. Further research is needed to evaluate the role of biopsychosocial therapies, in addition to traditional interstitial cystitis medical therapies for women with a history of abuse and interstitial cystitis.

Sexual function and sexual distress in women with interstitial cystitis: a case-control study.

OBJECTIVES: To evaluate female sexual dysfunction (FSD) in women with interstitial cystitis (IC) versus a control group. Specific areas of FSD in women with IC have not been reported. METHODS: A mailed survey was sent to 5000 randomly selected women from the United States (controls) and 407 women with IC from a large referral center (cases). The Female Sexual Distress Scale and questions about sexual function, desire, orgasm, and pain were included. The Student t test was used to compare the mean values, and the chi-square test was used to compare the proportions between the cases and controls. RESULTS: During adolescence (the start of menstruation through age 18), having had intercourse, levels of sexual desire, and orgasm frequency did not differ significantly between the cases and controls. However, a significantly greater proportion of cases reported fear of pain (P = 0.018) and pain with intercourse (P = 0.001). In adulthood, a significantly greater proportion of cases reported having pelvic pain, fear of pain during intercourse, and dyspareunia (P <0.001 for all). Furthermore, after the diagnosis of IC, the number of cases reporting moderate to high desire (P <0.001) and orgasm frequently and very frequently declined significantly (P <0.001). The mean value of the Female Sexual Distress Scale was greater among established IC cases (18.5 +/- 14.3) compared with controls (8.3 +/- 10.2; P <0.001). A score of 15 or greater on the Female Sexual Distress Scale has been associated with sexual distress. CONCLUSIONS: Women with IC have significantly more FSD and sexual distress than women without IC. Additional study is needed to explore the multiple factors contributing to FSD in IC.