1063Vol. 10 | No. 4 | Autumn 2013 |U R O LO G Y J O U R N A L 1Department of Urology, G.Hatzikosta General Hospital, 450 01, Ioannina, Greece. Nikolaos Grivas1, Ioannis Tsimaris1, Aikaterini Makatsori1, Konstantinos Hastazeris1, Vasillios Kafarakis1 and Nikolaos E. Stavropoulos1 The Effectiveness of Otis Urethrotomy Combined with Six Weeks Urethral Dilations Until 40 Fr in the Treatment of Bladder Outlet Obstruction in Women: A Prospective Study Corresponding author: Grivas Nikolaos, MD, PhD Department of Urology, G. Hatzikosta General Hospital, Makriyianni Avenue 45001, Ioannina, Perfecture of Epirus, Greece. Tel: +302 651 080 408 Fax: +302 651 080 546 E-mail: ngrivas@cc.uoi.gr Received June 2012 Accepted February 2013 Purpose: To evaluate the effectiveness of Otis urethrotomy combined with six weekly urethral dilations until 40 French (Fr) in the treatment of women with urodynamic diagnosis of bladder outlet obstruction (BOO). Materials and Methods: Women diagnosed with lower urinary tract symptoms underwent urodynamic evaluation. Severity of symptoms and quality of life were assessed with interna- tional prostate symptom score (IPSS) and quality of life (QoL) questionnaires. Bladder outlet obstruction was defined as the presence of two or more of the following: maximum flow rate (Qmax) < 12 mL/s, detrusor pressure at maximum flow (PdetQmax) > 50 cmH2O and urethral resistance factor (URF) greater than 0.2. Ten out of 25 women diagnosed with BOO met the criteria. All women underwent Otis urethrotomy to 40 F and six-week urethral dilations until 40 F. After six months all patients underwent free uroflowmetry. Moreover post voiding residual (PVR), IPSS-QoL were recorded. Results: Six months post-operatively there was a significant improvement in all parameters: IPSS = 13.5 vs. 22.5 (P = .001), QoL = 3 vs. 5 (P = .001), voided volume = 312 mL vs. 216 mL (P = .055), Qmax = 27.5 mL/s vs. 12 mL/s (P = .001), and PVR = 27.5 mL vs. 170 mL (P = .005). Five women had close follow up during an average of 82 months. They maintained improved QoL (P < .005) and low PVR (P < .002). All other parameters lost their statistical significance. Conclusion: The described therapeutical modality seems to improve all clinical and urodynam- ic parameters in women with evidence of BOO not related to detrusor sphincter dyssynergia or obvious functional and anatomical pathology. Keywords: urinary bladder neck obstruction; female; urodynamics; quality of life; urination disorders. FEMALE UROLOGY 1064 | INTRODUCTION The overall incidence of bladder outlet obstruction (BOO) among women presenting with lower urinary tract symptoms (LUTS) is estimated between 1% and 30%. This great range in incidence could be attributed to the different definitions given for women with BOO which mainly refer to patients symptoms, pressure-flow studies,(1,2) imaging results(3) or combination methods.(4) Causes of BOO in women could be divided into anatomic (pelvic organ pro- lapse, uterine fibroids, previous stress urinary incontinence surgery, urethral strictures, atrophic vaginitis, urethral diver- ticula, primary bladder neck obstruction) and functional (de- trusor - sphincter dyssynergia, dysfunctional voiding, Fowler syndrome). Literature suggests that treatment of these wom- en could be the anatomical reconstruction of bladder neck, urethral dilations, Otis urethrotomy and intermittent self- catheterizations.(5) Aim of this study is to investigate the therapeutic efficacy of Otis urethrotomy combined with 6-week urethral dilations until 40 Fr in women with urodynamic evidence of BOO cor- related with coordinated relaxation of the urethral sphincter in EMG during voiding while no obvious anatomical or func- tional obstacle exists. MATERIALS AND METHODS This is a prospective study with an enrollment period from October 2001 to October 2006. Candidates to enter this study were women with LUTS due to BOO. Medical history and voiding diary were recorded, while all patients filled IPSS and QoL questionnaires. Clinical assessment included gy- necological and neurological examination. Patients with suspected neurological disease were referred for further in- vestigation to a neurologist. All women were submitted to uroflowmetry and PVR measurement. Urodynamic study was accomplished according to the in- structions of the International Continence Society.(6) Adhe- sive skin surface electrodes on the perineum were used to record electromyography of the urethral sphincter, while the patient was in the sitting position. The rate of adminis- tration of normal saline was 50 mL/min unless voiding di- ary showed evidence of small bladder capacity or detrusor overactivity appeared during the examination. In the last two cases the filling rate was reduced to 30 mL/min. We used the diagnostic algorithm of Massey and Abrams(5) to assess BOO in women. Obstruction was defined as the coexistence of at least two of the following criteria: a) maximum urine flow during pressure-flow study (Qmax) < 12 mL/s, b) det- rusor pressure at maximum flow (PdetQmax) > 50 cmH2O and c) Abrams-Griffiths urethral resistance factor (URF) > 0.2. URF is calculated from the equation URF = PdetQmax/ Qmax2. The above algorithm helps to avoid overdiagno- sis of BOO in women.(7) Women excluded from the study were those suffering from neurogenic bladder, pelvic organ prolapse, patients with a history of previous dilatations and pelvic or stress incontinence surgery, those with a large in- crease in intraabdominal pressure during voiding (intraab- dominal pressure increase > 20 cmH2O ), patients with det- rusor-sphincter dyssynergia or poor relaxation of pelvic floor muscles. Those who met the inclusion criteria, i.e. those with BOO and coordinated relaxation of the urethral sphincter in electromyography (EMG), were submitted to Otis urethroto- my and 6-week urethral dilations until 40 Fr. The procedure was as follows: under general anesthesia cystoscopy was performed using a 18 Fr cystoscopy sheath. Subsequently an Otis urethrotome was placed in the urethra, while the blad- der was filled with 250 mL 0.9% NaCl. Otis urethrotomy to 40 Fr was performed along the 12 hour of the urethra. At the end of the procedure a 18 Fr Foley catheter was placed. Next morning catheter was removed and after hospital discharge all women underwent 6-week urethral dilations until 40 Fr. Six months after surgery follow up included uroflowmetry, post void residual measurement and IPSS and QoL question- naires assessment. Data analysis was made with Wilcoxon t test and chi-square test. A P value of < .05 was considered statistically significant. RESULTS Ten women fulfilled the entry criteria of the study. The aver- age age was 65.7 years (54-80 years). During cystoscopy the majority of women (90%) were found to have bladder trabec- ulae. The cystoscope entry was difficult in three women. No patient was diagnosed with urethral stricture. IPSS param- eters before and after surgery are shown in Table 1. Patients had severe preoperatively voiding and storage symptoms, with a median IPSS value of 21.5. After Otis urethrotomy and 6-week urethral dilations there was statistically signifi- Female Urology 1065Vol. 10 | No. 4 | Autumn 2013 |U R O LO G Y J O U R N A L cant improvement in total IPSS, straining, urgency and urine flow (P = .000; P = .000; P = .004; and P = .000, respective- ly). Table 2 presents preoperatively data along with results at 6 months postoperatively and in August 2011. Median preoperative maximum detrusor pressure was 68 cmH2O. All parameters, i.e. urinary flow, post voiding residual, urine volume, IPSS score and QoL were significantly improved 6 months after surgery (P =.001; P = .005; P = .055; P = .001; and P < .0001, respectively). No woman had stress inconti- nence post-operatively. In August 2011 only 5 women accepted reevaluation but all of them refused to undergo urodynamic testing. The median post-operative interval period was 82 (55-107) months. Data from Table 2 show that the improvement of quality of life and PVR are maintained, both at statistically significant levels (P < .005 and P < .002, respectively) compared with preopera- tive values. DISCUSSION Bladder outlet obstruction in women is a diagnostic chal- lenge because there is no agreed definition.(8) Recently its existence as a clinical entity is increasingly confirmed as shown by the number of articles published concerning diag- nostic algorithms(5,7) or cut-off definition points.(9-12) The re- producibility of pressure flow studies seems to be very good in the literature. Nomograms have been described to assess a possible obstruction, but some studies show no correlation between the severity of symptoms of BOO and results on the main nomogram (nomogram of Blaivas).(13) We used the di- agnostic algorithm of Mossey and Abrams for the diagnosis of BOO in women presenting with lower urinary tract symp- toms.(5) It was considered the best diagnostic method among the models proposed during the entry year of the study, i.e. 2001. The inclusion of more parameters, i.e. Qmax, PdetQ- max and URF ensured greater diagnostic accuracy. In 2006 Akinwala and colleagues(7) compared all the suggested methods of BOO diagnosis and concluded that Mossey and Abrams method probably results in underdiagnosis. In 2000 Groutz and colleagues(14) was the first who tried to apply men self-assessment questionnaires in women with symptoms suggesting BOO. This study included a group of patients with specific urodynamic characteristics i.e. women who had coordinated urethral sphincter relaxation in EMG dur- ing voiding and BOO with no obvious anatomical or func- tional obstacle. The results were excellent at 6 months but in the long term only the improvements in QoL and PVR were maintained. It is interesting that Qmax appeared to be slightly worse in long term. However this result does not limit the ef- ficacy of our method, since PVR and QoL are considered to be the most important treatment parameters. The main limitation of this trial was a lack of control group. Effectiveness of Otis Urethrotomy in Women | Grivas et al Table 1. IPSS parameters and total IPSS score preoperatively and 6 months after surgery. IPSS Before Surgery Six months post-operatively P Voiding 2 (0–3) 1 (0–2) .132 Frequency 3 (1–5) 3 (2–3) .342 Intermittency 3 (0–5) 2 (1–3) .095 Urgency 4 (2–4) 3 (2–3) .004 Weak stream 4 (4–5) 1 (0–2) .000 Straining 4 (3–5) 1 (0–2) .000 Nocturia Total score 3 (1–3) 21.5 (17–28) 2 (1–3) 11 (10–15) .343 .000 Key: IPSS, International Prostate Symptom Score. Table 2. Urodynamic and clinical findings preoperatively at 6 months and 82 months post-operatively. Preoperatively Six months post-operatively 82 (55-107) months post-operatively IPSS 21.5 ( 17- 28) 11 ( 10-15 ), P = .001 22 (18-28), P = .442 QoL 5 ( 5-6) 3 (3-4), P < .0001 4, (P < .005) Voiding Volume, mL 216 ( 157-762) 312 (205-768), P =. 055 315.8 (92-1038 ), P = .124 Qmax, mL/s 12 (6-15) 27.5 (11.6-53), P = .001 10.3 ( 6-12.4), P = .645 P detQmax , cmH 2 O 68 (40-87) NA NA PVR, mL 170 (35-610) 27.5 (0-30), P = .005 42 (15-80) P < .002 URF 0.44 (0.22-0.52) NA NA Key: IPSS, international prostate symptom score; QoL, quality of life; Qmax, maximum flow rate; P detQmax , detrusor pressure at maximum flow rate; PVR, post voiding residual; URF, urethral resistance factor. 1066 | Another drawback of this study is that the imaging evalu- ation didn’t include voiding cystourethrography. We didn’t proceed to this diagnostic method because it would not help to the differential diagnosis. It could only help to determine the exact location of the obstacle which in any case would have the same therapeutic approach. Moreover it is well de- fined that no correlation exists between urethral diameter and urodynamic diagnosis of BOO unless it is ≤ 10 Fr.(15) No woman needed urethral dilations for the placement of 18 Fr cystoscope. Otis urethrotomy probably results in: tempo- rary partial paralysis of the external sphincter in patients with detrusor–sphincter dyssynergia,(16) bladder neck or urethral stricture,(17) and urethral denervation due to dilatation.(18) Other studies present Otis urethrotomy as an empirical treat- ment because there are no data which record its effectiveness objectively.(19) Otis urethrotomy has been applied to treat recurrent bladder infections(20) and urethral syndrome(21) but no therapeutic effectiveness was proved. Urethral overdistension to treat symptoms of lower urinary tract in women showed well short term results.(22) CONCLUSIONS Our study showed very good short term results when we combined Otis urethrotomy with 6-week urethral dilations. Surgery resulted in statistically significant reduction in IPSS score, improved QoL, increased Qmax, reduced post voiding residual and increased voided volume. The improvement in quality of life and residual volume seems to be maintained in long term. ACKNOWLEDGMENTS This work was attributed to the Urology Department, G. Hatzikosta General Hospital, Ioannina, Greece. CONFLICT OF INTEREST None declared. REFERENCES 1. Lemack GE, Zimmern PE. Pressure flow analysis may aid in identify- ing woman with outflow obstruction. J Urol. 2000;163:1823-8. 2. Chassagne S, Bernier PA, Haab F, Roehrborn CG, Reish JL, Zimmern PE. Proposed cutoff values to define bladder outlet obstruction in woman. Urology. 1998;51:408-11. 3. Nitti VW, Tu LM, Gitlin J. 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