Surgery for stress urinary incontinence in Finland 1987–2009

Introduction and hypothesis

To estimate the incidence rates of stress urinary incontinence (SUI) surgery among Finnish women from 1987 to 2009 by age, and to evaluate the trends in SUI surgery.

Methods

We conducted a retrospective register-based study. All SUI procedures on adult women over age 18 years in Finland were identified from the nationwide Care Register for Health Care. Age-specific incidence rates per 1,000 women were calculated for each year. The cumulative incidence of SUI surgery was calculated.

Results

There were 38,340 procedures for SUI in 1987–2009. The overall age-adjusted incidence rate increased 2.6-fold from 0.5/1,000 women in 1987 to 1.3/1,000 in 2002, but declined thereafter by 2009 to 0.8/1,000. There was a six-fold increase in the incidence rate in the age group 60–69 years and a ten-fold increase in the age group 70–79 years from 1987 to 2002. These marked increases in operation rates coincided with the increased use of tension-free vaginal tape (TVT). In 2002, TVT accounted for 96 % of all SUI procedures. Mid-urethral slings with transobturator techniques surpassed TVT in popularity in 2007. The life-long cumulative incidence of SUI surgery was 9.9 % in 2002 and 6.3 % in 2009.

Conclusions

The incidence rates of SUI surgery increased significantly in Finland, especially among women aged 60 to 79 years. Mid-urethral slings have become the dominant procedure.

     

The role of calpain–calpastatin system in the development of stress urinary incontinence

Introduction and hypothesis  

The objective of this study is to investigate the expression of calpain-1, calpain-2, and calpastatin in the human periurethral vaginal tissues and to show the potential link between calpain system and stress urinary incontinence (SUI).     

Does body mass index influence the outcome of midurethral sling procedures for stress urinary incontinence?

Introduction and hypothesis

Whether midurethral sling (MUS) procedures are as effective in obese women as they are in women of normal weight is still a matter of controversy. The objective of this study was to determine if body mass index (BMI) influences the outcome of MUS procedures for stress urinary incontinence (SUI).

Methods

We searched electronic databases including EMBASE, MEDLINE, Web of Science and Ovid evidence-based medicine reviews to identify studies that explored the association between BMI and outcomes of MUS procedures. The studies were rated using the Newcastle-Ottawa scale; the meta-analysis was performed using Review Manager 5.3 software.

Results

This review included 11 studies, 6 prospective cohort studies and 5 retrospective studies, with a total of 2,846 patients. The objective success rates of MUS in patients with BMI >25 kg/m² (overweight and obese) were lower than in patients with BMI 18.5 – <25 kg/m² (normal weight; RR?=?0.93, 95 % CI 0.89 – 0.97; P?=?0.002). The objective success rates were not significantly different between the overweight group (BMI 25 – <30 kg/m²) and the obese group (BMI ≥30 kg/m²; RR?=?0.95, 95 % CI 0.89 – 1.01; P?=?0.08). There were no significant differences in subjective outcomes among the different BMI groups: BMI ≥25 kg/m² versus 18.5 – <25 kg/m² (RR?=?1.03, 95 % CI 0.97 – 1.10; P?=?0.29), and BMI ≥30 kg/m² versus 25 – <30 kg/m² (RR?=?0.98, 95 % CI 0.92 – 1.04; P?=?0.55).

Conclusions

The objective success rates of MUS were lower in overweight and obese patients; however, the subjective outcomes of MUS were not significantly different among normal weight, overweight and obese patients. The MUS procedure is as effective in obese women as in women of normal weight, and therefore surgeons should not consider BMI >25 kg/m² as a risk factor when discussing the suitability of the MUS procedure in a patient with SUI.

     

Which are reasonable diagnostic procedures in the evaluation of urinary incontinence in the elderly?

The ageing of our society continuously increases the number of frail elderly patients in the incontinence cohort. Shortage of financial and personnel resources demands reasonable and purposeful use of the diagnostic armamentarium. All intended diagnostic procedures should follow an algorithm hierarchized for invasiveness and should be limited to the minimum extent necessary for initiation of a conservative first-line treatment. Reasonable diagnostics objectify patients' complaints, differentiate between subgroups, reveal underlying pathologies and comorbidities, classify incontinence severity, support the therapeutic strategy, identify possible treatment complications and serve as follow-up tools. Diagnostic results have to be documented in detail and the procedures must be as easy and minimally invasive as possible. Basic diagnostics in urinary incontinence comprise patient history, clinical examination, urinalysis, uroflowmetry and sonographic post-void residual measurement, voiding diary and evaluation of the mental status. With these procedures, the vast majority of elderly patients can be classified correctly and a conservative first-line treatment can be started. Only a minority of patients with incongruent diagnostic results or recurrent incontinence refractory to conservative therapy should undergo further special diagnostics (urethrocystoscopy, urodynamics, morphologic and functional radiologic imaging, perineal or introital ultrasound) if they lead to therapeutic consequences. If not, expensive special diagnostics should be omitted in elderly patients due to their inherent morbidity.     

Contasure-needleless® compared with Monarc® for the treatment of stress urinary incontinence

Introduction and hypothesis

For the treatment of stress urinary incontinence (SUI), various retropubic and transobturator techniques have demonstrated high cure rates. Single-incision tapes, such as Contasure-Needleless® (C-NDL), have demonstrated similar cure rates to the inside-out transobturator sling (TVT-O®).The aim of this study was to analyse if C-NDL® is equally as effective as an outside-in transobturator sling (Monarc®) for the treatment of SUI.

Methods

We carried out a prospective, single-centre, randomised trial. The results were analysed for a non-inferiority test with a minimum postoperative follow-up of 12 months. The objective and subjective cure rates were evaluated by a stress test and a postoperative Sandvik Severity Index respectively. Patient satisfaction and operative complications were registered. The cure was defined by a negative stress test and SSI 0.

Results

A total of 187 patients were included, 89 and 98 undergoing C-NDL® and Monarc® respectively. Epidemiological and clinical data did not show and significant differences between both groups except a high prevalence of women who smoke (15.7% C-NDL® vs 6.1% Monarc®, p 0.03). The negative stress test was negative in 72 patients (80.9%) in C-NDL® compared with 85 (88.5%) in Monarc® (p 0.082). The SSI was 0 in 47 (66.2%) for C-NDL® and 61 (70.1%) for the Monarc® group (p 0.01). There were 14 (16.1%) and 8 (8.3%) dissatisfied patients for the C-NDL® and Monarc® groups respectively (p 0.068). The rate of complications was similar in both groups.

Conclusions

According to the non-inferiority test, C-NDL® is not inferior to Monarc® (post-surgical SSI test), but it is inferior in the comparison of a negative stress test and patient satisfaction.

     

Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature

Introduction and hypothesis

Polyacrylamide hydrogel (PAHG, Bulkamid®) is one of several injectable agents currently used for the treatment of women with urinary stress incontinence. Although bulking agents appear to have lower efficacy rates compared to other surgical treatments, current evidence based on large prospective or comparative studies as well as systematic reviews is limited. The purpose of this study was to conduct a systematic review on the efficacy of PAHG in the treatment of female patients with stress urinary incontinence with regard to reproducibility, feasibility, safety and clinical outcome.

Methods

We searched MEDLINE (1966–2015), Scopus (2004–2015), POPLINE (1974–2015) and ClinicalTrials.gov (2008–2015) along with reference lists of electronically retrieved studies. Observational studies, prospective, retrospective and randomized controlled studies were included. Two reviewers independently selected studies, assessed the risk of bias and tabulated data to structured forms.

Results

We included 8 studies, which enrolled a total of 767 patients who received treatment with PAHG. We found that 186 of 767 women (24.3 %, range 12–35 %) required reinjection in order to achieve adequate efficacy. The most frequent adverse effects were pain at the site of injection (4–14 %) and urinary tract infections (3–7 %). Both the number of incontinence episodes/24 h and the number of ml/24 h were significantly reduced 1 year following treatment and the quality of life of patients was significantly improved.

Conclusions

PAHG is a safe intervention for treating women with stress urinary incontinence, but repeat injections are often required. Further research is mandated in the field in order to compare its efficacy to other bulking agents.

     

Long-term outcomes of the Ajust® Adjustable Single-Incision Sling for the treatment of stress urinary incontinence

Introduction and hypothesis

The aim of this study was to evaluate the effectiveness and overall safety of the Ajust® Adjustable Single-Incision Sling in the treatment of female stress urinary incontinence.

Methods

This was a prospective, multicenter study conducted in women diagnosed with stress urinary incontinence. The Ajust® Sling was implanted and patients were followed postoperatively for up to 29 months. Evaluations were performed to assess postoperative rate of continence, complications, and patient quality of life (QOL).

Results

From November 2008 through May 2009, 52 patients were enrolled and underwent a procedure to implant the Ajust® Sling. Overall, 86.3 % of the patients who successfully received the Ajust® Sling demonstrated total restoration or improvement of continence at the last study visit. QOL scores related to global bladder feeling and lifestyle improved. Only one patient reported the occurrence of mild pain which resolved without treatment or sequelae.

Conclusions

In long-term follow-up, the Ajust® Sling was safe and effective, restoring or improving continence in 86.3 % of patients.     

Are the outcomes of transobturator tape procedure for female stress urinary incontinence durable in long-term follow-up?

Purpose

To evaluate long-term cure rates and late complication rates after treatment for female stress urinary incontinence (SUI) with transobturator tape (TOT) procedure and to compare the outcomes of 1st year versus 5th year.

Methods

We analyzed 138 women who underwent TOT procedure for pure SUI and mixed urinary incontinence in two institutions during the time period of June 2005–May 2008 retrospectively. We used two kinds of polypropylene monofilament tapes (Heine Medizin^®urethral support system, Germany and I-STOP^®CL Medical, France) for the standard outside-in TOT in similar numbers. All patients were evaluated with pelvic examination including cough stress test and International Consultation on Incontinence Questionnaire-Short Form at 3 and 12 months and annually. Our primary outcome measures were rates of objective cure, subjective cure, patient satisfaction and failure for long-term follow-up.

Results

The objective cure, subjective cure and patient satisfaction rates of the 126 women at 1 year were 89.6, 86.5 and 92 % respectively. During 5-year follow-up, objective cure rate was stable with 87.3 % rate (p = 0.554), whereas subjective cure and patient satisfaction rates were decreased to 65.9 and 73 %, respectively (p = 0.001). Complications are reported according to the Clavien–Dindo classification with Gr I 14.3 %, Gr II 64.3 %, Gr IIIa 7.1 % and Gr IIIb 14.3 %.

Conclusions

TOT procedure is an effective minimal invasive procedure with satisfactory results for female SUI in short term. Although recovery in SUI symptoms was stable during 5-year follow-up, subjective cure and patient satisfaction rates decreased significantly due to urge urinary incontinence symptoms.     

Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence

Introduction and hypothesis

The minimally invasive tension-free vaginal tape (TVT) operation has become the “gold standard” of incontinence surgery. The aim of the present study was to evaluate the long-term effect of the tape material and to assess the continence status 17 years after surgery

Methods

A cohort of 90 women operated upon with the TVT procedure at three Nordic centers has been prospectively followed for 17 years. All of the women alive according to national registries were contacted and invited to visit the clinics for evaluation. Pelvic examination was performed to reveal any adverse effects of the tape material. Objective and subjective continence status were assessed by a cough stress test and the patients’ global impression of improvement as well as by condition-specific quality of life questionnaires.

Results

Seventy-eight percent of the potentially assessable women were evaluated either by a clinic visit or by a telephone interview. One case of a minimal, symptom-free tape extrusion was seen. No other tape complications occurred. Over 90 % of the women were objectively continent. Eighty-seven per cent were subjectively cured or significantly improved.

Conclusion

The TVT operation is durable for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects     

Effects of Macroplastique® Implantation System for stress urinary incontinence and urethral hypermobility in women

A study was carried out to evaluate efficacy of Macroplastique® (MPQ) Implantation System (MIS) in women with urodynamic stress urinary incontinence (SUI) and urethral hypermobility after an unsuccessful conservative treatment. This is a prospective randomized controlled trial in women without previous incontinence surgery. Twenty-four women received MPQ. Twenty-one controls underwent a pelvic floor muscle exercises home program. Follow-up was at 3 months and the MPQ group also at 12 months. At 3 months, pad usage decreased significantly more in the MPQ group than in the control group (p?=?0.015). According to physician and patient self-assessment, respectively, 71% and 63% women in the MPQ group were considered cured or markedly improved. This was significantly higher compared to controls. There was a significant higher increase of Incontinence Quality-of-Life questionnaire score in the MPQ group compared to controls (p?=?0.017). Improvements in MPQ group at 3 months are sustained to 12 months. Adverse events were mild and transient. MIS is an acceptable option for women with SUI and urethral hypermobility.     

Is HCl duloxetine effective in the management of urinary stress incontinence after radical prostatectomy?

INTRODUCTION: Up to 70% of patients who undergo radical prostatectomy complain about urine leakage, but persistent stress incontinence 1 year after surgery affects <5% of them. HCl duloxetine is a dual serotonin and norepinephrine reuptake inhibitor that relieves the symptoms of stress urinary incontinence. The purpose of this study was to evaluate the efficacy of HCl duloxetine in the management of urinary incontinence after radical prostatectomy and its impact in urodynamic parameters such as maximal urethral closure pressure (MUCP), abdominal leak point pressure (ALPP) and retrograde leak point pressure (RLPP). MATERIAL AND METHODS: The study included 18 men with stress urinary incontinence 12 months after radical prostatectomy. All underwent a pad test to quantify the degree of urine loss and a urodynamic evaluation before and after a three month treatment with HCl duloxetine. The intrinsic sphincter was evaluated by ALPP and RLPP and the striated sphincter by MUCP. RESULTS: At the pretreatment evaluation the mean ALPP was 52.1 cm H(2)O, the mean MUCP was 52.5 cm H(2)O and the mean RLPP was 43.1 cm H(2)O. After 3 months of HCl duloxetine treatment the mean ALPP was 59.1 cm H(2)O, the mean MUCP was 67.3 cm H(2)O and the mean RLPP was 45.1 cm H(2)O. There was a statistically significant correlation among RLPP, MUCP and ALPP before treatment. After HCl duloxetine treatment there was significant correlation between RLPP and ALPP. CONCLUSION: The use of HCl duloxetine results in mild increase of MUCP and in significant reduction of urine loss. Its action on the extrinsic sphincter does not provide a complete treatment option for postprostatectomy incontinence.     

Predicting the development of stress urinary incontinence 3?years after hysterectomy

Introduction and hypothesis  

We aimed to develop a prediction rule to predict the individual risk to develop stress urinary incontinence (SUI) after hysterectomy.