C Ciofu

Pierre and Marie Curie University - Paris 6, Lutetia Parisorum, Île-de-France, France

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Publications (50)128.97 Total impact

  • [show abstract] [hide abstract]
    ABSTRACT: To conduct a review about the use of single incision mini-slings (SIMS) to manage non-neurogenic stress urinary incontinence in women. Literature search in Pubmed/MEdline database until june 2013. TVT-Secur™ was excluded because this device is not anymore marketed. Ajust™ and Mini-Arc™ were the two main SIMS evaluated in the literature. Studies about Mini-Arc™ generated heterogeneous results, with a success rate between 44% and 91% after 1year. Ajust™ was the most promising device with 80% efficacy after mid-term follow-up. All evaluated SIMS had a low rate of immediate complications. Two randomized controlled trials comparing SIMS and traditional mid-urethral slings were identified, as well as one meta-analysis; they all concluded to non-superiority or inferiority for the mini-sling versus traditional slings. Due to short follow-up, limited evidence and heterogeneous data, SIMS are not yet standard of care and further research is warranted.
    Progrès en Urologie 09/2013; 23(11):917-25. · 0.80 Impact Factor
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    ABSTRACT: Objectives To assess the clinical outcome following artificial urinary sphincter (AUS) implantation after failure of Advance™ sub-urethral male sling for post-prostatectomy incontinence (PPI). Methods A prospective evaluation was conducted about consecutive patients who received an AUS after failure of Advance™ therapy in one tertiary reference center. Evaluation included medical history, pad use and operative data (duration, cuff size, technical difficulties). Follow-up was scheduled at 1, 6, 12 months and yearly thereafter. Clinical outcome was evaluated by pad use, patient global impression of improvement (PGI-I) scale and assessment of side effects. Cure was defined as no pad usage. Results Twelve patients were included in this evaluation. Median follow-up was 20 months (12–43). No patient was lost to follow-up. Four patients had a history of radiation therapy and all patients had mild or moderate PPI with previous failed Advance™ surgery. Median (range) operative time was 47 minutes (40–60). No technical problem occurred during AUS implantation. Hospital stay duration and catheterization duration were respectively 2 days and 24 hours in all but one case. At last follow-up, 10/12 patients (83%) were cured and fully satisfied. Two were improved, wearing only one pad per day. Postoperative complications were noted in two cases (17%) (one case of cutaneous erosion and one case of superficial iliac wound infection). Conclusions AUS implantation is feasible in patients who have undergone Advance™ male sling implantation. Mid-term results of this procedure are comparable to those obtained after first line AUS implantation.
    Progrès en Urologie. 10/2012; 22(11):650–656.
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    ABSTRACT: Purpose To assess the diagnostic performances and the acceptability of the penile cuff test (PCT) which is a non invasive method for the evaluation of bladder outlet obstruction (BOO), in comparison with the pressure flow study (PFS), the actual gold-standard. Material Monocentric prospective study comparing the following subsets: “obstructed”, “not obstructed” or “equivocal”, deduced from PFS vs PCT, in 30 consecutive patients presenting with lower urinary tract symptoms. For the PCT, a cuff placed around the penis inflated automatically during the micturition, until flow rate interruption. The interruption cuff pressure revealed the isovolumetric bladder pressure (Pcuff-int). The data collected – Pcuff-int and maximum flow rate – were automatically reported on ICS modified nomogram. Results With the PFS, 11 patients (39%) were classified “obstructed”, six patients (22%) “non-obstructed” and 11 patients (39%) “equivocal”. In 61% cases, the patient was classified in the same category by both techniques. The “obstructed positive predictive value” of the PCT was 82% and the “non-obstructed-equivocal negative predictive value” was 88%. The median acceptability visual analogic scale score was 1/10 (0–3) for the PCT whereas it was 5/10 (2–10) for the PFS. This difference was statistically significant (p = 0.004). Conclusion The PCT was a reliable non-invasive tool for the diagnosis of BOO in male, in comparison with PFS. The predictive values of the PCT were relevant and its tolerance was better than PFS.
    Progrès en Urologie. 10/2012; 22(11):657–664.
  • European Urology 07/2012; 62(4):737-8. · 10.48 Impact Factor
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    ABSTRACT: INTRODUCTION AND HYPOTHESIS: Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management. METHODS: A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. RESULTS: Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (-31.7 ± 65.1 % vs -7.6 ± 24.5 %, p = 0.002, -2.4 ± 2.6 vs 0.2 ± 2.2, p = 0.004, and -1.5 ± 2.8 vs 0.2 ± 1.8, p = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. CONCLUSIONS: The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.
    International Urogynecology Journal 05/2012; · 2.17 Impact Factor
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    ABSTRACT: Data on the Ajust, a new single-incision sling procedure for female stress urinary incontinence (SUI) management, remain scarce and limited to a 1-year follow-up. Our goal was to assess the efficacy of this procedure after a 1-year follow-up. This prospective evaluation involved 95 consecutive patients implanted with Ajust at a single centre. All patients had SUI on urodynamics due to urethral hypermobility, 33 % had preoperative overactive bladder (OAB) symptoms and none had detrusor overactivity. Ninety-two patients were treated on an outpatient basis, and 3 patients had general anaesthesia. Postoperative assessment was conducted at 1, 6, 12 months, and yearly thereafter. The main outcome measure was pad usage. Secondary parameters were self-reported SUI episodes, OAB symptoms, data of clinical examination, satisfaction using the Patient Global Impression of Improvement (PGI-I) scale, postoperative pain, and adverse events. After a mean follow-up of 21 ± 6 months (12-32), 76 out of 95 patients used no pads or one dry security pad, showing a success rate of 80 %. Seventy-nine out of 95 patients had no more SUI-related leakage. Only 6 patients experienced late recurrence of SUI after 6 months' follow-up. Perioperative complications included 1 case of vaginal hematoma, 1 case of acute urinary retention, 2 cases of urinary tract infection, all managed conservatively. Half of the patients had no pain after day 1, free of medications. Late complications were vaginal erosion in 1 case, and pain during exertion in 2 cases. The Ajust single incision transobturator sling is a safe and effective procedure, with durable results after 1 year.
    International Urogynecology Journal 05/2012; 23(9):1265-70. · 2.17 Impact Factor
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    ABSTRACT: Cell therapy for urinary incontinence management has been experienced in animals with encouraging results, but studies in human beings are lacking. Our primary objective was to assess the safety of intrasphincteric injections of autologous muscular cells in patients with postprostatectomy incontinence (PPI). Secondary objectives focused on complications efficacy. We conducted an open, prospective study in a single center on 12 patients presenting PPI. Patients underwent intrasphincteric injections of autologous muscular cells isolated from a biopsy of deltoid muscle. The primary endpoint was the Q(max) variation at the three month visit in order to assess potential bladder outlet obstruction. Secondary endpoints assessed side effects and efficacy parameters based on symptoms, quality of life score, voiding diary, pad-test, and urethral pressure profile at one, two, three, six and 12 months after injection. No immediate complication occurred and no significant variation was noted on Q(max). The only side effects possibly product-related were three cases of urinary tract infection treated by antibiotics. An acceptable safety and tolerability of the procedure whatever the injected dose of muscular cells was demonstrated. Results on efficacy after one year were heterogeneous, with 4/12 patients describing reduced urine leakage episodes, 1/12 patient presenting increased maximal closure pressure, and 8/12 patients showing improvement on pad-test. Cell therapy consisting of intrasphincteric injections of autologous muscular cells in patients with PPI was a feasible and safe procedure. The results point out that some subjects may positively respond to this procedure, but clinical efficacy remains to be confirmed.
    Progrès en Urologie 11/2011; 21(12):859-65. · 0.80 Impact Factor
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    ABSTRACT: Female urinary incontinence becomes a real public health issue in France, with high frequency and outcomes on 20 to 30% of concerned women. Prevalence of incontinence is widely under-estimated because few women consult a physician for this problem, and because of the lack of epidemiologic data about it. Despite female urinary incontinence will increase in the next future with "baby boom" population, and in spite of new treatments, medical help is not suitable. Physicians but also nurses and physical therapists must have better professional training to help and care better these women.
    La Revue du praticien 09/2011; 61(7):958-61.
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    ABSTRACT: Stress urinary incontinence (SUI) and erectile dysfunction (ED) are two major complications following radical prostatectomy (RP). In case of failure of medical treatment, Advance™ retrourethral male sling and penile implant are validated options to manage respectively SUI and ED. Our goal was to assess the feasibility and results of the combination of these two devices. Four patients were treated for SUI and DE following RP in our institution by retrourethral sling and penile prosthesis, after failure of medical management. Each patient was preoperatively evaluated by age, complete medical history, ASA score, endoscopy, pad-test, and urodynamics. The first two patients were implanted with the two devices in a two-stage procedure: retrourethral sling then penile prosthesis for one, and penile prosthesis then retrourethral sling for the other. The two other patients underwent a one-stage procedure: one received the two devices, and the other had retrourethral sling implantation and replacement of a penile prosthesis. Post-operative follow-up was focused on complications and efficacy (evaluated by pad use and PGI-I questionnaire for continence, and patient auto-evaluation for sexual function). No perioperative complication occurred. After a minimum of 6 months follow-up, all the four patients were pad-free with no leakage reported, feeling very much better after the procedure according to the PGI-I. The four patients were fully satisfied of the penile implant device. According to our initial experience, surgery combining the transobturator Advance male sling and a penile prosthesis is feasible, successively or simultaneously, and leads to excellent functional results with no complications.
    Progrès en Urologie 05/2011; 21(5):349-53. · 0.80 Impact Factor
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    ABSTRACT: Although existence of genetic factors predisposing to urinary incontinence in women is widely admitted, precise molecular and genetic variations implicated are still unknown. Given the established influence of steroids metabolism in incontinence, we studied the correlation between polymorphisms of genes of oestrogen/androgen pathways and urinary incontinence in women, in order to raise evidence of genetic susceptibility. A case-control study included 121 cases and 66 controls. Age, familial history of incontinence, gynaecologic history and age of menopause were collected. Patients were classified into three groups: control, urge urinary incontinence (UUI), stress urinary incontinence (SUI). Genetic polymorphisms were determined after amplification by PCR for the following genes: CYP-19, CYP17, androgen receptor (AR) and oestrogen receptor (ESR-1). Statistical analysis was performed to study correlation between genotype and presence of a subtype of incontinence. A total of 187 patients were analysed: 66 were controls, 30 presented UUI and 107 presented SUI. Patients presenting incontinence had significantly more often familial history of incontinence than controls. AR polymorphism (combination of 2 alleles containing more than 21 CAG repeats) is significantly associated with UUI (P = 0.02). Polymorphisms of ESR-1, CYP17 and CYP19 were not associated with any subtype of urinary incontinence. This study shows that AR polymorphism is linked to genetic susceptibility to urinary incontinence. This result suggests that this disease is partly gene-related and encourages larger studies to explore the genetics factors of urinary incontinence.
    World Journal of Urology 04/2011; 29(2):239-42. · 2.89 Impact Factor
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    ABSTRACT: Cell therapy for stress urinary incontinence (SUI) management has been experienced with encouraging results. We conducted an open prospective study on 12 women presenting severe SUI with fixed urethra, after previous failed surgical management. Patients underwent intrasphincteric injections of autologous progenitor muscular cells isolated from a biopsy of deltoid muscle. Primary endpoint focused on safety (measurement of Q(max) variation after 3 months). Secondary endpoints assessed side effects and efficacy. No variation was diagnosed on Q(max) measurements. Efficacy data show that three of 12 patients are dry at 12 months, seven other patients are improved on pad test but not on voiding diary, and two patients were slightly worsened by the procedure. Quality of life was improved in half of patients. Cell therapy for severe multioperated cases of SUI is a mini-invasive, feasible, and safe procedure that can improve urinary condition in as a second line therapy.
    International Urogynecology Journal 02/2011; 22(2):183-9. · 2.17 Impact Factor
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    ABSTRACT: Purpose Stress urinary incontinence (SUI) and erectile dysfunction (ED) are two major complications following radical prostatectomy (RP). In case of failure of medical treatment, Advance™ retrourethral male sling and penile implant are validated options to manage respectively SUI and ED. Our goal was to assess the feasibility and results of the combination of these two devices. Patients and methods Four patients were treated for SUI and DE following RP in our institution by retrourethral sling and penile prosthesis, after failure of medical management. Each patient was preoperatively evaluated by age, complete medical history, ASA score, endoscopy, pad-test, and urodynamics. The first two patients were implanted with the two devices in a two-stage procedure: retrourethral sling then penile prosthesis for one, and penile prosthesis then retrourethral sling for the other. The two other patients underwent a one-stage procedure: one received the two devices, and the other had retrourethral sling implantation and replacement of a penile prosthesis. Post-operative follow-up was focused on complications and efficacy (evaluated by pad use and PGI-I questionnaire for continence, and patient auto-evaluation for sexual function). Results No perioperative complication occurred. After a minimum of 6 months follow-up, all the four patients were pad-free with no leakage reported, feeling very much better after the procedure according to the PGI-I. The four patients were fully satisfied of the penile implant device. Conclusions According to our initial experience, surgery combining the transobturator Advance male sling and a penile prosthesis is feasible, successively or simultaneously, and leads to excellent functional results with no complications.
    Progres En Urologie - PROG UROL. 01/2011; 21(5):349-353.
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    ABSTRACT: • To assess clinical outcomes at mid-term follow-up and determine preoperative factors associated with the failure of the Advance(TM) male sling for post-prostatectomy incontinence (PPI). • A prospective evaluation was conducted of 136 consecutive patients implanted with the Advance(TM) male sling for mild to moderate stress urinary incontinence after prostatectomy. • Patients were preoperatively evaluated using medical history, ASA score, urodynamics, 24-h pad test and pad usage. • The clinical outcome was evaluated according to pad use and the Patient Global Impression of Improvement scale and by assessment of side effects. 'Cure' was defined as no pad usage and 'improvement' as a decrease in pad use by >50%. • Factors related to functional outcome were studied by univariate and multivariate analysis. • After a mean ± SD (range) follow-up of 21 ± 6 (12-36) months, 62% of patients were cured, 16% improved and 22% not improved. • Failure (no cure or improvement) was associated with previous urethral stricture surgery (P= 0.013) and a 24-h pad-test >200 g/day (P= 0.026), and there was a trend for an association with previous radiation therapy (P= 0.053). • Age, learning curve and type of prostatectomy did not affect the results. • Immediate postoperative complications were limited to two cases of dysuria, one case of perineal haematoma and two cases of perineal paresthesia. During follow-up, 10% of patients had perineal pain and 14% of patients had mild dysuria. None required surgical management. • The results of the present study, with a follow-up of up to 3 years, confirm that the Advance(TM) male sling is an efficient treatment for PPI. However, particular attention should be given to the preoperative data associated with failure.
    BJU International 10/2010; 108(2):236-40. · 3.05 Impact Factor
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    ABSTRACT: Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). To establish the superiority of duloxetine over placebo in SUI after RP. We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.
    European Urology 10/2010; 59(1):148-54. · 10.48 Impact Factor
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    ABSTRACT: TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies. Our goal was to evaluate the outcome of this procedure after a midterm follow-up. A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP). Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon. Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score < or = 2; as improved in case of reduction of SUI symptoms >50% and PGI-I score < or = 3; and as failure otherwise. Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group. Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women.
    European Urology 04/2010; 58(1):157-61. · 10.48 Impact Factor
  • Urology 01/2010; 76(3). · 2.42 Impact Factor
  • Journal of Urology - J UROL. 01/2010; 183(4).
  • Journal of Minimally Invasive Gynecology - J MINIM INVASIVE GYNECOL. 01/2010; 17(6).
  • Urology 01/2010; 76(3). · 2.42 Impact Factor
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    ABSTRACT: Transobturator male slings have been proposed to manage stress urinary incontinence (SUI) after prostatic surgery, but data are still lacking. To determine the safety and prospectively evaluate the clinical outcome after management of SUI after prostatic surgery by placement of a transobturator male sling. We conducted a prospective evaluation on 102 patients treated in a single center between 2007 and 2009 for mild to moderate SUI following prostatic surgery. Placement of a suburethral transobturator sling and clinical follow-up. Patients were evaluated by medical history, preoperative urodynamics, maximum flow rate measurement, 24-h pad test, and daily pad use. During follow-up, data on patients' pad use, complications, and answers to the Patient Global Impression of Improvement (PGI-I) questionnaire were collected. Cure was defined as no pad usage or one pad for security reasons and improvement as reduction of pads≥50%. Median follow-up was 13 mo (range: 6-26). Most patients (95%) presented post-radical prostatectomy incontinence (PRPI). Hospital stay was 2 d in 97 cases, and all patients were catheterized for 24h except two (48 h). Of 102 patients, 64 were cured, 18 were improved, and 20 were not improved. According to the PGI-I questionnaire, 85%, 11%, and 4% of patients described a respectively better, unchanged, and worse urinary tract condition, respectively. Previous radiation was associated with higher rate of failure (p=0.039). Neither severe complication nor postoperative urinary obstruction was noted during follow-up. Placement of a transobturator sling is a safe and effective procedure, giving durable results after >1 yr of follow-up. Further evaluation and high-quality controlled, randomized studies are needed to assess long-term efficacy and precise indications of this procedure for post-prostatic-surgery SUI management.
    European Urology 09/2009; 56(6):923-7. · 10.48 Impact Factor

Publication Stats

463 Citations
128.97 Total Impact Points

Institutions

  • 2012
    • Pierre and Marie Curie University - Paris 6
      Lutetia Parisorum, Île-de-France, France
  • 2003–2012
    • Assistance Publique – Hôpitaux de Paris
      • Department of Radiology
      Lutetia Parisorum, Île-de-France, France
  • 2011
    • Hôpital Tenon (Hôpitaux Universitaires Est Parisien)
      Lutetia Parisorum, Île-de-France, France
  • 2008
    • Centre Hospitalier Régional Universitaire de Lille
      Lille, Nord-Pas-de-Calais, France