Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling

Introduction and hypothesis

Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust? SIMS and the Align? transobturator tape sling.

Methods

We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported.

Results

We randomized 30 women to the Ajust? group and 28 to the Align? group. At 1 year the cure/improvement rates were 93.3% in the Ajust? group and 96.4% in the Align? group. The rate difference for cure/improvement was of ?3.1% (95% CI ?14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust? SIMS under the pre-established criteria. Three women in the Ajust? group reported persistent thigh pain 1 year after surgery, but none in the Align? group reported pain.

Conclusions

At 1 year, the Ajust? SIMS showed non-inferior effectiveness compared with the Align? transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust? group.

     

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.

     

Five-year follow-up study of Monarc transobturator tape for surgical treatment of primary stress urinary incontinence

Introduction and hypothesis

We hypothesized that transobturator tape (TOT) is safe and efficacious for the treatment of urodynamic stress incontinence in the long term.

Methods

We conducted a prospective study of patients with confirmed urodynamic stress incontinence (USI) who underwent a Monarc^TM TOT procedure in a tertiary center between February 2006 and March 2009 without other concurrent surgical procedures. Urodynamics were conducted at 1 and 3 years postoperatively. Subjective evaluation included Incontinence Impact Questionnaire (IIQ-7), Urinary Distress Inventory Questionnaire (UDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Objective cure was defined as no urinary leakage demonstrable on provocative filling cystometry and/ or 1-h pad test of <2 g. Subjective cure was based on a negative response to question 3 in UDI-6. Paired-samples t test, chi-square, and Fisher exact tests were applied; p?<?0.05 was considered significant. The log-rank tests were used to compare event-free survival.

Results

Sixty patients were enrolled, and 56 were evaluated at 5 years postoperatively. The majority were middle aged, postmenopausal, and overweight. Mean operating time was 31.1?±?8.9 min, intraoperative complications were minor, and median period of follow-up was 80.3?±?9.6 months. At 5 years of follow-up, objective and subjective cure rates were 89.3 % and 87.5 %, respectively. No mesh-related complications were seen. One patient needed a repeat midurethral sling procedure, and one patient each had bladder and bowel cancer.

Conclusion

Monarc TOT was safe and retained its high cure rate in the short- and long-term treatment of stress urinary incontinence.

     

41st Annual Meeting – Cape Town,South Africa August 4 – 5, 2016

Introduction and hypothesis

Stress urinary incontinence is a common problem affecting 12-46 % of women. A cohort of women have a more severe form of stress urinary incontinence usually due to intrinsic urethral sphincter deficiency that has traditionally resulted in lower success rates with standard treatment modalities. We aim to address the question of whether transobturator sling insertion is more effective than retropubic sling insertion in the treatment of intrinsic sphincter deficiency-related stress urinary incontinence in women.

Methods

We searched MEDLINE, CINAHL, CENTRAL, journals, and major conferences (up to 30 June 2014). All randomised controlled trials in women with stress urinary incontinence or mixed urinary incontinence with associated intrinsic sphincter deficiency who underwent a retropubic or transobturator mid-urethral sling operation were included in this meta-analysis. The Cochrane risk of bias tool and the GRADE system were used to assess the quality of evidence.

Results

Fifty-five randomised controlled trials compared transobturator and retropubic mid-urethral slings. Twelve trials included women with intrinsic sphincter deficiency, but only 8 trials (399 women) reported data specifically for this cohort. There was a statistically significant difference in short- and medium-term (≤5 years) subjective cure rates, with the number of women reporting a cure in the transobturator group at 150 out of 199 and the retropubic group at 171 out of 200. This gives a 12 % relative risk reduction in achieving cure with the transobturator route (RR 0.88, 95 % CI 0.80 to 0.96, I²?=?0 %, moderate quality evidence [GRADE]). Objective cure was reported by five trials of 324 women and showed no statistically significant difference between the two groups, with a rate of 110 out of 159 in the transobturator group and 126 out of 165 in the retropubic group (RR 0.90, 95 % CI 0.79 to 1.03). Post-operative voiding dysfunction and de novo urgency or urgency urinary incontinence in the two treatment groups showed no significant difference. The need to undergo repeat incontinence surgery in the long term (≥5 years) was higher with the transobturator route (RR 14.4, 95 % CI 1.95 to 106, 147 women).

Conclusions

Mid-urethral slings are effective in treating women with intrinsic sphincter deficiency-associated stress urinary incontinence. The retropubic route resulted in higher subjective cure rates compared with transobturator routes. Both routes improved the overall quality of life.

     

Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial

Purpose

To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI).

Methods

A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6–IIQ7), and patient satisfaction on a scale from 0 to 10.

Results

Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan–Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference.

Conclusion

The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.

     

A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up

Introduction and hypothesis

Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up.

Methods

We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals.

Results

We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR ?5; 95% CI ?0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR ?1; 95% CI ?0.10 to 0.07). Both procedures have low complication rates.

Conclusions

At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

     

A randomized,nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence

Introduction and hypothesis

Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up.

Methods

This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student’s t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure.

Results

We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference ?0.6%, 95% CI ?12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI ?9 to 11%). Both procedures were associated with low complication rates.

Conclusions

After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.

     

Adipose-derived stem cells seeded on polyglycolic acid for the treatment of stress urinary incontinence

Purpose

To evaluate the effect and possible mechanism of suburethral tissue-engineered sling in an animal model of stress urinary incontinence (SUI).

Methods

Adipose-derived stem cells (ADSCs) were obtained from the adipose tissues of rats. The differentiation potential, proliferation, and viability of rat ADSCs were evaluated after infecting these cells with a lentiviral vector-encoding green fluorescent protein (GFP). Next, GFP transfected ADSCs were seeded on polyglycolic acid (PGA) fibers to construct the tissue-engineered sling with the induction of 5-azacytidine (5-Aza). Afterward, the tissue-engineered slings were transplanted into a rat model of SUI that was established by vaginal balloon dilatation method and bilateral ovariectomy. Histology and the leak point pressure measurements were performed at 2 months after tissue-engineered sling implantation.

Results

The ADSCs were found to be efficiently transfected with GFP, without any effects on proliferation, cell cycle and multi-differentiation potential. After been seeded on PGA fibers, ADSCs formed tissue-engineered slings in 4 weeks of induction culture. Two months after implantation, the mean leak point pressure (LPP) was significantly increased in sling-treated rats compared with the balloon-injured ovariectomized rats. Immunofluorescence assay showed that some of the GFP expressing cells stained positive for muscle-specific markers.

Conclusions

The newly suburethral tissue-engineered sling restores LPP in the rat model of SUI, which could be an effective treatment in future SUI therapy.

     

Evaluation of the local carcinogenic potential of mesh used in the treatment of female stress urinary incontinence

Introduction and hypothesis

To evaluate the carcinogenic potential of implanted synthetic mesh midurethral slings in the treatment of female stress urinary incontinence.

Methods

We identified female patients undergoing implantation of mesh materials for stress urinary incontinence at our institution from 1 January 2002 to 31 December 2012. This was accomplished by querying the medical records for CPT code 57288 (“sling operation for stress incontinence”) and a subsequent chart review to identify patients who underwent synthetic mesh sling placement. Medical records were then evaluated for the documentation of bladder, urethral, vaginal, cervical, uterine or ovarian cancers via the International Classification of Disease (ninth edition) coding. A chart review of patients with a cancer diagnosis was performed for verification of the diagnosis and evaluation of the temporal relationship with sling placement.

Results

During the study period, 2,474 patients underwent polypropylene midurethral sling placement. The median age was 57 years (IQR 47, 69) and the median follow-up was 60 months (IQR 23.3, 94.9). Overall, 51 patients also had a cancer diagnosis (8 bladder cancers, 7 vaginal malignancies, 8 ovarian carcinomas, 26 endometrial cancers, 2 cervical malignancies); however, only 2 cancers (0.08 %, 2 out of 2,474) developed following sling placement (a vaginal melanoma 3 years after sling placement and an ovarian tumor 1 year after sling placement). No cases of sarcoma formation, bladder, urethral or squamous cell carcinomas were identified.

Conclusions

With a median follow-up of 5 years after synthetic midurethral sling placement, development of pelvic malignancy was rare (0.08 %) and unlikely to be secondary to foreign body reaction from the implanted material.

     

Outcome of coexistent overactive bladder symptoms in women with urodynamic urinary incontinence following anti-incontinence surgery

Introduction and hypothesis

The objective was to investigate the outcome of stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms in women with urodynamic stress incontinence (USI) after transobturator sling procedures (TOTs).

Methods

We evaluated 109 consecutive patients with USI, who had undergone TOT in a tertiary hospital between 2012 and 2014. All patients received evaluations, including structured urogynecological questionnaires and pelvic organ prolapse quantification examination before, and 3 and 12 months after surgery. One-hour pad test and urodynamic testing were performed before and 3–6 months postoperatively. Patient demographics, lower urinary tract symptoms, and urodynamic results were analyzed between pure USI and USI with OAB symptoms.

Results

Persistent SUI occurred in 8 patients at 3 months (7.3 %) and 7 patients at 12 months (6.4 %) postoperatively. The most common OAB symptom was frequency (54.1 %), followed by urgency urinary incontinence (52.3 %), urinary urgency (42.2 %), and nocturia (33 %). Most of these OAB symptoms were resolved at the 3-month and 12-month follow-ups both in patients treated with TOT only and in those treated with TOT combined with other pelvic surgeries. There was no significant difference in the preoperative urodynamic changes between patients with pure USI and USI without OAB groups. However, postoperative urodynamic results showed a significant decrease in the maximal urethral closure pressure in the group of patients with USI and OAB symptoms, but no significant urodynamic changes in the group with pure USI.

Conclusions

Coexistent OAB symptoms are common in women who were diagnosed with USI and most of these symptoms may resolve 3 and 12 months after TOT.

     

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.

     

Are suburethral slings less successful in the elderly?

Introduction and hypothesis

We aimed to evaluate the success of suburethral slings in women ≥70 years of age.

Methods

This was a retrospective cohort study of women who underwent suburethral sling placement. Subjects were separated into three groups: ≤50 years of age (group 1), 51 to 69 years of age (group 2), and ≥70 years of age (group 3). The primary aim was to evaluate success as defined by ≥ improved on a validated patient improvement satisfaction score and a negative postoperative standardized stress test.

Results

There were 1,464 subjects. Mean age was 44.51?±?4.25 (n?=?296) for group 1, 60.5?±?5.28 (n?=?680) for group 2, and 77.68?±?5.41 (n?=?488) for group 3. The median follow-up was 26 (6–498) weeks, 45 (6–498) weeks, and 42 (6–543) weeks, for groups 1, 2, and 3 respectively. Multiple logistic regression analysis demonstrated no difference in sling success according to age stratification. Lower success was associated with having had a previous sling (adjusted OR 0.25, 95 % CI 0.12–0.5), having detrusor overactivity (adjusted OR 0.44, 95 % CI 0.28–0.69), and having a history of urge urinary incontinence (UUI) for ≥ 4 years (adjusted OR 0.54, 95 % CI 0.31–0.95).

Conclusions

There is no difference in sling success between the elderly and younger populations. However, those with previous sling surgery or a long standing history of UUI may be at a higher risk of failure.

     

King’s Health Questionnaire to assess subjective outcomes after surgical treatment for urinary incontinence: can it be useful?

Introduction and hypothesis

Midurethral slings (MUS) are the mainstay of treatment for stress urinary incontinence, but the definition of success varies widely amongst studies. The King’s Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. We hypothesised that the KHQ could be useful for postoperative quantitative assessment of subjective outcomes.

Materials and methods

This is a retrospective analysis of 204 patients who underwent incontinence surgery with transobturator MUS between 2004 and 2013. Follow-up was planned at 6, 12 and 24 months and success was evaluated using the cough stress test (objective cure) and the KHQ global score (subjective outcomes). Statistical analysis included receiver operating characteristic (ROC) curves to calculate a cut-off value for the KHQ global score to define subjective cure. The minimal clinically important difference was calculated with a distribution-based method (effect size) to estimate subjective improvement.

Results

Objective cure rates were 97 % and 95 % at 6 and 24 months respectively. ROC curves established the cut-off score at?≤?31 for subjective cure, with sensitivity of 63–100 % and specificity of 82–88 %. Subjective cure rates were 80 % and 85 % at 6 and 24 months respectively. The minimal clinically important difference was set at 10 and an improvement of?≥?10 points was defined as subjective improvement. Rates varied between 10 and 13 %.

Conclusions

This study showed the value of the KHQ as an evaluation tool after UI surgery and determined clinically relevant threshold scores to define subjective outcomes.

     

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.

     

De novo overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis

Introduction and hypothesis

De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence.

Methods

We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05.

Results

Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58).

Conclusions

Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.

     

Risk factors for failure of repeat midurethral sling surgery for recurrent or persistent stress urinary incontinence

Introduction and hypothesis

To study the outcomes following repeat midurethral sling (MUS) surgery in patients with persistent or recurrent stress urinary incontinence after failure of primary MUS surgery and risk factors for surgical failure.

Methods

The medical records of 24 patients who underwent repeat MUS surgery at a single tertiary center from January 2004 to February 2014 were reviewed. The types of MUS used for the repeat surgey were transobturator, retropubic and single incision slings. Objective cure was defined as no demonstrable involuntary leakage of urine during increased abdominal pressure in the absence of a detrusor contraction observed during filling cystometry, and subjective cure was defined as a negative response to Urogenital Distress Inventory six (UDI-6) question 3 during follow-up between 6 months and 1 year postoperatively. The change in the inclination angle between the urethra and pubic axis was measured with introital ultrasonography and the cotton swab test performed.

Results

The objective and subjective cure rates were 79.2 % and 75 %, respectively. There were no differences in demographics between the patients with failure of surgery and those with successful surgery. Significant independent risk factors for failure of repeat MUS surgery were a change in cotton swab angle at rest and straining of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), a change in inclination angle of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), intrinsic sphincter deficiency (OR 3.4, 95 % CI 1.8 – 6.1) and a mean urethral closure pressure of <60 cm H₂O (OR 2.9, 95 % CI 1.5 – 4.5). In one patient the bladder was perforated.

Conclusions

Repeat MUS surgery is safe and has a good short-term success rate, both objectively and subjectively, with independent risk factors for failure related to bladder neck hypomobility and poor urethral function.

     

Five years after midurethral sling surgery for stress incontinence: obesity continues to have an impact on outcomes

Introduction and hypothesis

The objective was to evaluate the impact of preoperative body mass index ≥30 on objective and subjective cure rates 5 years after midurethral sling surgery.

Methods

Secondary analysis of the 5-year results of a randomized clinical trial evaluating tension-free vaginal tape vs transobturator tape surgery. Women (n?=?176) were classified as obese or non-obese based on preoperative height and weight. Women self-reported symptoms and quality of life, and underwent standardized physical examinations and pad-testing. Categorical data were analyzed using Chi-squared or Fisher’s exact tests, continuous data by Mann–Whitney U test. Primary outcome was objective cure defined as <1 g urine lost on pad-test at 5 years post-surgery. Secondary outcomes were subjective cure of incontinence, urinary urge incontinence symptoms, and quality of life scores.

Results

Non-obese women had a higher rate of objective cure, 87.4 % (n?=?83 out of 95) compared with 65.9 % (n?=?29 out of 44) in the obese group (P?=?0.003, risk difference [RD] 21.5 %, 95 % CI 5.9–37.0 %). Subjectively, non-obese women also reported higher rates of cure, 76.7 % (n?=?89 out of 116) compared with 53.6 % (n?=?30 out of 56) of obese women (P?=?0.002, RD 23.2 %, 95 % CI 8.0–38.3 %). Overall rates of urge incontinence symptoms were similar in the two groups, but rates of bothersome symptoms were higher for obese women (58.9 % vs 42.1 %, P?=?0.039, RD 16.8 % 95 % CI 1.1–32.6).

Conclusions

Five years after surgery, obese women continued to experience lower rates of cure compared with non-obese women.

     

High urinary flow in women with stress incontinence: corrected flow–age nomogram evaluation after a transobturator tape procedure

Introduction and hypothesis

We noninvasively compared urinary flow in both pre- and post-transobturator tape (TOT) procedures in stress urinary incontinence (SUI) patients using previously reported corrected flow–age nomograms in healthy women.

Methods

This retrospective cohort study included patients who underwent a successful TOT procedure to treat SUI. Non-instrumented uroflowmetry was performed before and 3 months after surgery. Corrected maximum flow rate (cQmax) and average flow rate (cQave) were calculated using Qmax/√voided volume (VV) and Qave/√VV respectively. The ratio of corrected flow to age-adjusted corrected flow in healthy women was calculated in each patient. Each parameter was compared against pre-TOT and 3-months post-TOT values.

Results

Sixty-two patients were eligible for study inclusion. All urinary flow parameters were significantly higher pre-TOT than at 3 months post-TOT. The number of patients with cQmax and cQave over mean flow–age nomogram, compared with healthy women, before the TOT procedure decreased 3 months post-TOT; however, in many patients, cQmax and cQave were higher than in the corrected flow–age nomogram post-TOT. No significant difference in the ratio of cQmax to age-adjusted cQmax between pre- and post-TOT in the normal urinary flow group was observed, but significantly decreased in the high urinary flow group 3 months after TOT.

Conclusions

Urinary flow rates were higher in SUI patients compared with age-matched controls and successful TOT procedures normalized urinary flows in patients with high urinary flow. A simple evaluation of urinary flow using a corrected flow–age nomogram may be clinically useful in SUI patients.