Functional results after the suburethral sling procedure for urinary stress incontinence: a prospective randomized multicentre study comparing the retropubic and transobturator routes

OBJECTIVES: To compare short-term functional outcomes, urodynamic parameters, and quality of life of transobturator and retropubic routes in the cure of urinary stress incontinence. POPULATION AND METHODS: This prospective, multicentre study involved 88 women undergoing suburethral sling procedure for stress urinary incontinence (SUI). The retropubic route (RPR) and the transobturator route (TOR) were used in 42 and 46 women, respectively. No difference in epidemiologic and preoperative urinary functional status (SUI stage, and pollakiuria, nocturia, and urgency rates) was found between the groups. Functional results and quality of life were evaluated before surgery and at 1, 3, 6, and 12 mo postoperatively. Urodynamic examinations were performed before and 3 mo after surgery. RESULTS: The mean follow-up was 10 mo. No difference in the rate of de novo urge incontinence and immediate and late voiding dysfunction was noted between the groups. No difference in the cure rate was observed between the groups (89.3% in the RPR group and 88.6% in the TOR group). RPR was associated with a significant decrease in maximum urinary flow and an increase in residual urine volume. Quality of life was significantly improved after surgery without difference between the groups. CONCLUSIONS: Retropubic and transobturator routes for treatment of female SUI have similar high cure rates and quality of life improvement. Because of advantages in the rate of complications and postoperative pain previously demonstrated on the same population, the transobturator route appears to be the best option for the treatment of urinary incontinence.     

Peri-operative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes

OBJECTIVE: To compare peri-operative complications, pain, and the immediate functional results of the sub-urethral sling procedure for urinary stress incontinence by the retropublic and transobturator routes, using a non-elastic polypropylene sub-urethral sling. PATIENTS AND METHODS: This prospective, multicentre study involved 88 women undergoing the sub-urethral sling procedure for stress urinary incontinence (SUI). The retropubic route (RPR) and the transobturator route (TOR) were used in respectively 42 and 46 cases. The characteristics of the women in the RPR and TOR groups were as follows: mean age (+/-standard deviation) 56.8+/-12 years and 53.4+/-10 years, respectively; mean BMI: 25+/-4 and 26+/-4; mean parity: 2.1+/-0.9 and 2+/-1 children; post-menopausal status: 66.7% and 58.7%; prior surgery for SUI: 7.1% and 6.5%; and prior hysterectomy: 21.4% and 26.1%. None of these characteristics differed significantly between the groups. Likewise, pre-operative urinary functional status (SUI stage, and pollakiuria, nocturia and urgency rates) was similar in the two groups. RESULTS: Mean hospital stay and overall morbidity rate were not significantly different between the RPR and TOR groups. Mean operating time was longer in the RPR group. Bladder injury was significantly more frequent in the RPR group and vaginal injury was significantly more frequent in the TOR group. Pain scores were significantly lower in the TOR group. The objective functional results at one month did not differ between the groups. Quality of life, evaluated with questionnaires and numerical rating scales, was similarly improved in the two groups. DISCUSSION: The suburethral sling procedure was less painful by the TOR route than by the RPR route. Bladder injury, haematomas and abscesses were only observed in the RPR group, while vaginal injury only occurred in the TOR group. The immediate functional results of the two approaches were similar.     

Readjustable transobturator sling: a novel sling procedure for male urinary incontinence

Post-prostatectomy incontinence remains a significant problem for both patients and urologists. We report a case and the surgical technique of successful sling in the treatment of post-prostatectomy urinary incontinence. Sling surgery was performed on a 69-year-old male patient with severe urinary incontinence (6 pads/day) following radical prostatectomy. The procedure was conducted through the transobturator approach using a sling with a silicone foam pad to protect the urethra. At the 7-month follow-up the patient is using only 1 pad/day. We consider this operation an alternative to artificial urinary sphincter in cases of male sphincter incontinence.     

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Introduction and hypothesis

We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI).

Methods

This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n?=?56) or TVT-S (n?=?66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p?<?0.05).

Results

Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) ?15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI ?11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p?<?0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p?<?0.001).

Conclusion

TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.     

Autologous transobturator midurethral sling placement: a novel outpatient procedure for female stress urinary incontinence

Introduction

We present a novel outpatient transobturator autologous rectus fascia midurethral sling procedure.

Methods

A 55-year old woman presented with stress urinary incontinence (SUI) as documented by history, physical exam, and 24-h pad test. Conservative and surgical treatment options were discussed. The patient was interested only in outpatient surgical options, however, and was adamantly opposed to any mesh procedures due to concerns regarding complications. Therefore, following an in-depth discussion and informed consent, a transobturator, autologous sling procedure was performed. The vaginal dissection was performed in the standard fashion. A rectus fascial strip measuring 7?×?1 cm rectus fascia was harvested. A trocar was passed through each obturator foramen. Fascial stay sutures were retracted through the skin incisions. The sling was then appropriately tensioned and the stay sutures tied together.

Results

The patient had an uncomplicated perioperative course. She voided spontaneously with low postvoid residual. At follow-up, she had no urinary leakage.

Conclusions

The transobturator autologous midurethral sling procedure is technically feasible and, in the short term, effective. Longer follow-up and larger series are needed to validate this procedure, which, however, may become a suitable option for patients and surgeons concerned with potential mesh complications.     

Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy

Study Type – Therapy (case series)
Level of Evidence 4 What’s known on the subject? and What does the study add? Several studies showed encouraging early results of the AdVance® sling. However, mid‐term and long‐term results are missing. We were able to show that the AdVance® sling is also, in a longer follow up (median follow‐up of 27 months), an effective, safe and attractive treatment option with stable results for male SUI after radical prostatectomy.

OBJECTIVE

? To evaluate prospectively the efficacy of the retroluminar transobturator male sling (AdVance® sling) for the functional treatment of stress urinary incontinence (SUI) after prostatectomy.

PATIENTS AND METHODS

? A total of 137 patients with grade II–IV SUI, resulting from radical prostatectomy, were treated with the AdVance® sling in a prospective clinical study. In all, 11 patients were lost to follow‐up. A total of 17 patients (13.5%) had additional adjuvant radiotherapy before sling implantation. ? Before and after sling implantation, a standardized 1‐h pad test was performed and post‐void residual urine, uroflowmetry, quality‐of‐life scores and the International Index of Erectile Function (IIEF‐5) were assessed. ? When calculating the cure and improvement rates, ‘cure’ was defined as no pad use or one dry prophylactic pad; and ‘improved’ was defined as 1–2 pads or reduction of pads ≥50%.

RESULTS

? After a median (range) follow‐up of 27 (20–37) months, and a mean follow‐up of 27.2 months, the success rate was 75.4% with 51.6%‘cured’ and 23.8%‘improved’. ? Overall daily pad use, urine loss in the 1‐h pad test and quality‐of‐life scores improved significantly after sling implantation. ? Compared with 1‐year follow‐up data, no worsening over time was noticed and no additional complications were seen.

CONCLUSION

? With a mid‐term follow‐up, the retroluminar transobturator male sling is an effective, safe and attractive treatment option for SUI after radical prostatectomy. Results are stable over time.     

The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study.

OBJECTIVE: To evaluate in a prospective multicentre study (five centres) the preliminary results regarding efficacy and morbidity of the new tension-free transvaginal tape (TVT) technique in the treatment of urinary stress incontinence (USI) in women. METHODS: From November 1996 to May 1999, 52 women of mean age 64 (range 37--91) years underwent the TVT procedure to treat isolated grade 2 or 3 USI (44 cases) or grade 1 or 2 USI associated with uterine or rectal prolapse surgery (8 cases). Twenty-nine patients (55.8%) presented recurrent USI (1--4 previous procedures). Clinical data showed urethrovesical junction hypermobility in 35 cases (67.3%), isolated intrinsic sphincter deficiency (ISD) in 17 cases (32.6%) and pelvic organ prolapse in 8 cases. Urodynamics confirmed ISD in 27 cases (51.9%) with a mean urethral closure pressure of 18.5 (range 7--25) cm H(2)O. All data were collected by surgeons on a questionnaire. RESULTS: The surgical procedure was performed under spinal cord anaesthesia in 82.7% of patients (local anaesthesia 11.5%) with a mean operation time of 30 (range 20--60) min for TVT implantation. Six bladder injuries (11.5%) were identified and the needle was repositioned. Mean hospital stay was 2.5 (range 1-7) days in the group who underwent TVT alone. Mean follow-up of continence was 15.2 (range 6--36) months: 83% of patients were dry and 17% were improved. Nine patients (17.3%) required self-catheterization for 2--10 days postoperatively. No recurrence of USI, defect healing or tape rejection were reported. CONCLUSION: TVT is a new technique for the surgical treatment of USI which is useful for recurrent cases. The advantages are simplicity, low morbidity, reproducibility and reduced operative time. These early results indicate the technique is effective in correcting incontinence and is locally well tolerated. But these are preliminary data and the long-term outcome on USI and the urethra is needed.     

The inside-out transobturator male sling for the surgical treatment of stress urinary incontinence after radical prostatectomy: midterm results of a single-center prospective study

Background

Transobturator slings are currently promoted for the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP), but data on outcome remain limited.

Objective

To assess, at midterm, the efficacy and safety of the inside-out transobturator male sling for treating post-RP SUI and to determine factors associated with failure.

Design, setting, and participants

Prospective one-center trial involving 173 consecutive patients without detrusor overactivity, treated between 2006 and 2011 for SUI following RP.

Intervention

Placement of an inside-out transobturator sling.

Measurements

Baseline and follow-up evaluations included uroflowmetry and continence and quality-of-life (QoL) questionnaires. Cure was defined as no pad use and improvement as a number of pads per day reduced by ≥50% and two or fewer pads. Complications were recorded, and factors associated with treatment failure were evaluated.

Results and limitations

Preoperatively, 21%, 35%, and 44% of the patients were using two, three to five, and more than five pads per day, respectively. After a median follow-up of 24 mo (range: 12-60 mo), 49% were cured, 35% improved, and 16% not improved. QoL was enhanced (p < 0.001), and 72% of patients were moderately to completely satisfied with the procedure. Maximum flow rates were slightly reduced (p = 0.004); postvoid residual volumes were similar (p = 0.097). Complications were urinary retention after catheter removal (15%), perineal/scrotal hematoma (9%), pain lasting >6 mo (3%), and sling infection (2%); all were managed conservatively. Severe SUI before sling surgery was not associated with a worse outcome, whereas obesity and a history of pelvic irradiation or bladder neck stenosis were independent risk factors of failure, with risk ratios of 7.9 (95% confidence interval [CI], 3.3-18.9), 3.3 (95% CI, 1.4-7.8), and 2.6 (95% CI, 1.1-6.5), respectively.

Conclusions

The inside-out transobturator male sling is an efficient and safe treatment for post-RP SUI at midterm. Patients with prior pelvic irradiation may not be suitable candidates.     

Effect of detrusor function on the therapeutic outcome of a suburethral sling procedure using a polypropylene sling for stress urinary incontinence in women

OBJECTIVE: To assess the effect of detrusor function on the therapeutic outcome of a suburethral sling procedure in women with stress urinary incontinence (SUI). MATERIAL AND METHODS: A total of 192 women with SUI who had undergone a suburethral sling procedure were enrolled. According to the baseline urodynamic results, patients' bladder functions were classified as follows: (i) normal detrusor function; (ii) detrusor overactivity; and (iii) detrusor underactivity or acontractile detrusor. Surgical results, urodynamic parameters and patient satisfaction were compared among these three groups. RESULTS: Overall, 106 patients had normal detrusor function, 36 had detrusor overactivity and 50 had detrusor underactivity or an acontractile detrusor. A continent outcome was achieved in 135 women (70.3%), urge incontinence in 23 (12%), minimal SUI in 32 (16.7%) and moderate SUI in two (1%). Persistent urge incontinence was noted in 13 women (36%) with detrusor overactivity, and recurrent SUI occurred in 18 women (36%) with detrusor underactivity or an acontractile detrusor. No significant change in urodynamic parameters between baseline and after treatment was found in any of the patient groups. The satisfaction rate was 98.1% in patients with normal detrusor function, 82% in patients with detrusor underactivity or an acontractile detrusor and 75% in patients with detrusor overactivity (p<0.05). CONCLUSION: Compared to women with normal detrusor function, those with preoperative detrusor overactivity and those with detrusor underactivity or an acontractile detrusor experienced an unfavorable therapeutic outcome of the suburethral sling procedure in terms of urge incontinence and recurrent SUI after surgery.     

Monarc transobturator sling system for the treatment of female urinary stress incontinence: results of a post-operative transvaginal ultrasonography

The aim of the study was to determine Monarc (American Medical Systems) sling position after surgical treatment of stress urinary incontinence (SUI) through the transobturator approach. A total of 54 consecutive women with SUI were evaluated post-operatively with transvaginal ultrasound. A concomitant hysterectomy was performed in ten cases and a concomitant prolapse surgery in six cases. Ultrasound measurements include urethral length, the distance between the upper edge of the sling and the bladder neck (BN–S) and the BN–S/U ratio. The mean distance between the transobturator tape and the bladder neck was found to be 12.6 ± 3.2 mm in the group of patients who underwent the transobturator procedure alone, 13 ± 3.1 mm in the transobturator plus hysterectomy group and 12 ± 2.8 mm in the transobturator plus prolapse group. The superior tape margin was at the mid-urethra in 81.5% of patients and always at a distance greater than 7 mm from the bladder neck. Eight patients did not have satisfactory results after the surgery. Only in one out of these eight patients was the transobturator sling not found to be at the mid-urethra. The superior tape margin of the Monarc sling remained at the level of mid-urethra in the majority of cases. It was never located too proximally beneath the bladder neck.     

Three-year results from a randomised trial of a retropubic mid-urethral sling versus the Miniarc single incision sling for stress urinary incontinence

Introduction and hypothesis

There are limited long-term efficacy data on single-incision slings. The primary aim of this study was to evaluate the success rate of a single-incision sling versus a retropubic mid-urethral sling for cure of SUI at 3 years’ follow-up, in order to assess whether there is a deterioration in efficacy over time. The secondary aims were to assess re-operation rates for each procedure and to evaluate any differences in disease-specific quality of life.

Methods

This study was a 3-year questionnaire-based follow-up of a randomised controlled trial of the Miniarc single-incision sling versus the Advantage retropubic mid-urethral sling. Patients were considered failures if they documented stress incontinence on the symptom domain of the King’s Health questionnaire (KHQ) or had undergone repeat surgery for stress incontinence.

Results

Follow-up was available from 35 out of 38 women in the single-incision sling group (92.1 %) and from 26 out of 33 in the retropubic mid-urethral sling group (79.0 %). The overall 3-year failure rate was 20 out of 38 (52.6 %) in the single-incision sling group and 3 out of 33 (9.0 %) in the retropubic mid-urethral sling group (odds ratio 10.0, 95 % confidence interval 2.6–38.4). In the single-incision sling group, the failure rate increased from 40.5 % at 6 months to 52.6 % at 3 years with corresponding figures of 3 to 9 % in the retropubic mid-urethral sling group.

Conclusions

In this study, there was a significantly higher 3-year failure rate for the single-incision sling versus the retropubic mid-urethral sling. Both procedures had reduced efficacy over time.     

Prospective randomized comparison of transobturator suburethral sling (Monarc) vs suprapubic arc (Sparc) sling procedures for female urodynamic stress incontinence

The aims of this trial were to compare the attendant complications and postoperative voiding function of the Monarc and suprapubic arc (Sparc) suburethral sling procedures. This is the first article in English literature to compare different suburethral sling procedures using prosthesis of the same material and the same weave. Sixty women with urodynamic stress incontinence alone or combined with pelvic prolapse less than International Continence Society stage II were randomly allocated to either the Monarc or Sparc group. A comparison of the peri- and postoperative results comprising complications and symptoms of voiding function revealed no significant differences between the two groups in a follow‐up ranged from 6 to 14 months (median, 9 months). However, the nonsignificant increase in tendency of inadvertent vaginal perforation and disability/pain of thigh (Monarc 12.9 vs Sparc 0.0%, p=0.112 and Monarc 12.9 vs Sparc 0.0%, p=0.112, respectively) has clinical significance. Based on the analyses of the comparison of Blaivas obstruction nomograms, postoperative voiding function was not significantly different between the two surgical groups. We concluded that Monarc and Sparc suburethral taping proved to be equally safe and posed no remarkable impact on voiding function in a short term postoperative follow up. However, intraoperative urethrocystoscopy is recommended for safety in both the Monarc and Sparc procedures.This study had no conflicts of interest as regards any commercial association.     

Sexual function following retropubic TVT and transobturator Monarc sling in women with intrinsic sphincter deficiency: a multicentre prospective study

Introduction and hypothesis  

A prospective study comparing the effect of the tension-free vaginal tape (TVT) to the Monarc sling on sexual function in women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD) is presented.     

Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study

Introduction and hypothesis

The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI).

Methods

A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient’s life quality.

Results

Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n?=?48) and SIS groups (n?=?45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6?±?1.8 vs 3.1?±?2.1, p?<?0.001) and 12 h postoperatively (3.8?±?1.7 vs 2.1?±?1.7, p?<?0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p?=?0.399) or patient-reported success rates (91.3 % vs 93.2 %; p?=?0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life.

Conclusions

The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.