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.

     

Safety and efficacy of single-incision sling for female stress urinary incontinence: 3 years’ results

Introduction and hypothesis

The purpose of this study was to investigate the success and complication rates of single-incision sling for treating stress urinary incontinence (SUI), with a 3-year follow-up.

Methods

This study comprised 173 female patients with SUI or mixed urinary incontinence (MUI) with dominant SUI who underwent minisling procedure. All patients had positive cough stress test preoperatively; they were followed up for 3 years after surgery (1, 3, 6, 12 months, and yearly).

Results

Total follow-up was 36 months, and mean age 51 years (44–77); 128 (74 %) patients presented SUI and 45 (26 %) MUI. Objective and subjective cure and failure rates were 83.8 % (145 cases), 6.4 % (11 cases), and 9.8 % (17 cases), respectively. There were no differences in cure rates between 1 and 3 years. Mean body mass index was 28.7 (26.1–35.2), and mean operating time 7.9 min. (6.5–11.9). There were no major intraoperative complications. Eleven patients (6.4 %) had de novo urge incontinence that resolved using anticholinergic drugs; no patient had urinary retention. Vaginal mesh extrusion was reported in nine (5.2 %) patients.

Conclusions

The minisling system attained high success rates at 3 years’ follow-up. The procedure was easy to learn and has lower complication rate.

     

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     

An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

Introduction

Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.

Methods

Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%).

Results

At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n?=?10). No polyacrylamide hydrogel-specific adverse events were seen.

Conclusions

Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.     

Magnet stimulation therapy: a simple solution for the treatment of stress and urge incontinence?

AIM: Magnet stimulation therapy has been offered as a new, conservative therapy for stress and urge incontinence in Germany since 2001. Focussed, pulsating magnetic fields are used to stimulate the musculature of the floor of the pelvis. This publication describes our initial experience with this method. PATIENTS AND METHODS: We treated 27 patients with magnetic stimulation. The individual patient sits clothed on a therapy-chair and is treated for 20 min twice a week for 2 weeks. RESULTS: The best results were recorded in female patients with grades I and II stress incontinence who could not actively flex their pelvic-floor musculature during physiotherapy. A marked reduction in the frequency of micturition was obtained in 67% of patients with urge incontinence symptoms and non-responsiveness to anticholinergic therapy. Patients with a non-organically tangible pelvic-pain-syndrome did not benefit from the therapy. CONCLUSIONS: Magnet stimulation therapy can act as a useful addition to conservative therapies for stress and urge incontinence. It is free of complications and does not involve the insertion of an electrode into the patient as is the case for vaginal and anal electrostimulation. However, this method does not appear to be useful for chronic, non-specific pain in the lower pelvis.     

TOT for treatment of stress urinary incontinence: how should we assess its equivalence with TVT?

Introduction and hypothesis  

Synthetic mid-urethral slings are currently considered the treatment of choice for stress urinary incontinence (SUI). In this study, two types of slings are compared: TVT vs. TOT.     

Is routine cystoscopy justified in female stress urinary incontinence?

The investigation of women with SUI the Serbian urologist traditionally begins with cystoscopy to reduced risk of bladder tumor. There is no doubt regarding its ability to detect bladder cancer presented with characteristic symptoms or pathologic results of urinalyses. We discuss its routine use in patients presenting with symptomatology of SUI. The retrospective study was performed in order to evaluate clinical justifiability and cost/benefit ratio of routine cystoscopy in women with stress urinary incontinence (SUI) whose were surgically treated. We reviewed records of 95 female, mean age 56,5 years (rang 46-78) who underwent SUI surgery at eight-year period. The clinical variables, including urinary symptoms, results of urinalyses, ultrasound records and cystoscopic findings, were obtained from the hospital reports. Insignificantly abnormal cystoscopic findings were reported in 31% patients (vagina-like epithel, trigonitis, uterus wall impression, hyperemia, polypoid proliferation and mild trabeculation). No cases of malignancy were incidentally discovered. In female SUI cystoscopic finding was insignificantly abnormal and was not influenced further therapy and contraindicated the planned SUI surgery. Routine cystoscopy in women with SUI cannot be justified only by customary practice or tradition of older generation urologists.     

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.     

Preliminary findings with the Solyx™ single-incision sling system in female stress urinary incontinence

Introduction and hypothesis  

The aim of this study was to test the safety and efficacy of the Solyx single-incision sling (SIS) in women with stress urinary incontinence (SUI).     

A new treatment of female stress urinary incontinence with vaginal antetheca–retropubic space mesh repair surgery: a clinical trial

Purpose

To investigate the short- and medium-term effect of vaginal antetheca submucosal-retropubic space with mesh repair through the implantation of organic patch (shortly as new-style vaginal mesh repair) in the treatment of patients with stress urinary incontinence (SUI).

Methods

This was a clinical prospective single arm study in a tertiary grade hospital (General Hospital of Jinan Military Region, Jinan, China). From January 2009 to December 2014, 316 female patients were enrolled. 316 female patients with stress urinary incontinence (SUI) underwent the surgery. The treatment effect was evaluated using the urinary incontinence questionnaire (ICIQ-SF), urine pad test and coughing test. The perioperative and postoperative complications were also evaluated. The results were compared with 1-year cure rates of Burch retropubic urethropexy (Burch) and tension-free vaginal tape (TVT) procedure.

Results

The mean follow-up period was 25 ± 12 months. The success rate of the new surgical technique was 94.0% (297/316) at 1 month, and 91.5% (289/316) at 1-year postoperation. The ICIQ-SF score significantly decreased at the 1-year follow-up (P < 0.01). There was no significant difference in the 1-year cure rate when compared with the Burch and TVT procedures (P > 0.05). The rates of perioperative urinary tract irritation and mesh exposure were 9.5% (30/316) and 5.38% (17/316), respectively, and no serious complications were found.

Conclusions

The surgery demonstrated favorable short-term and medium-term treatment effects. Given its advantages of being minimally invasive, cost efficient and requiring only local anesthesia, this new surgical technique has a potential for broader clinical application.

ClinicalTrials.gov ID

NCT02934490.