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Modification of bladder thermodynamics in stress urinary incontinence patients submitted to trans-obturator tape: A retrospective study based on urodynamic assessment.

ABSTRACT: Importance: It needs to be clarified whether trans-obturator tape (TOT)-enhanced urethral resistance could impact the voiding function. Objective: Although TOT has been well-recognized for enhancing urethral resistance to restore continence in stress urinary incontinence (SUI) patients, whether the bladder's voiding functions adapt to the TOT-enhanced resistance has not been adequately investigated. This study thereby aimed to investigate whether TOT impacts the bladder's thermodynamic efficacy during the voiding phase. Design: A retrospective analysis of urodynamics performed before and after TOT was assessed. Setting: A tertiary referral hospital in Taiwan. Participants: A total of 26 female SUI patients who underwent urodynamic investigations before and after TOT. Main outcomes and measures: The area enclosed by the pressure-volume loop (Apv), which represents the work performed by the bladder during voiding, in a pressure-volume analysis established by plotting the detrusor pressure versus intra-vesical volume was retrospectively analyzed. Paired Student's t-tests were employed to assess the difference in values before and after the operation. Significance in difference was set at p < 0.05. Results: TOT increased Apv in 20 of 26 (77%) patients and significantly increased the mean Apv compared to the preoperative control (2.17 ± 0.18 and 1.51 ± 0.13 × 10³ cmH₂O-ml, respectively p < 0.01). TOT also increased the mean urethral resistance (1.03 ± 0.30 vs. 0.29 ± 0.05 cmH2O-sec/ml, p < 0.01) and mean voiding pressure (25.87 ± 1.72 and 19.30 ± 1.98 cmH2O p < 0.01) but did not affect the voided volume and voiding time. Moreover, the TOT-induced Apv increment showed a moderate correlation with the changes in urethral resistance and voiding pressure (both r > 0.5) but no correlation with changes in voided volume or voiding time. It is remarkable that the TOT-induced urethral resistance increment showed a strong correlation with changes in voiding pressure (r > 0.7). Conclusion and Relevance: The bladder enhances thermodynamic efficacy by adapting the voiding mechanism to increased urethral resistance caused by TOT. Further studies with higher case series and longer follow-ups should assess whether this effect could be maintained over time or expire in a functional detrusor decompensation, to define diagnostic criteria that allow therapeutic interventions aimed at its prevention during the follow-up. Clinical Trial Registration: (clinicaltrials.gov), identifier (NCT05255289).

SUBMITTER: Lau HH

PROVIDER: S-EPMC9437260 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Modification of bladder thermodynamics in stress urinary incontinence patients submitted to trans-obturator tape: A retrospective study based on urodynamic assessment.

Lau Hui-Hsuan HH Lai Cheng-Yuan CY Peng Hsien-Yu HY Hsieh Ming-Chun MC Su Tsung-Hsien TH Lee Jie-Jen JJ Lin Tzer-Bin TB

Frontiers in bioengineering and biotechnology 20220819

<b>Importance:</b> It needs to be clarified whether trans-obturator tape (TOT)-enhanced urethral resistance could impact the voiding function. <b>Objective:</b> Although TOT has been well-recognized for enhancing urethral resistance to restore continence in stress urinary incontinence (SUI) patients, whether the bladder's voiding functions adapt to the TOT-enhanced resistance has not been adequately investigated. This study thereby aimed to investigate whether TOT impacts the bladder's thermodyn ...[more]

PMID: 36061421

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Project description:BackgroundWe recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial.Methods/designAll 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature.DiscussionThis study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs.Trial registrationClinicalTrials.gov NCT00234754. Registered October 2005.

Project description:(1) Background: Male stress incontinence in patients with previously treated urethral or bladder neck stricture is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is unknown. (2) Methods: All patients with primary ATOMS implants in our institution between 2014 and 2021 were included. The outcomes of patients with previously treated urethral or bladder neck stricture (≥6 months before ATOMS implant) and stable 16Ch urethral caliber were compared to those without a history of stricture. The primary endpoint was the dry patient rate, defined as the pad test ≤ 20 mL/day, and complication rate, including device removal. The secondary variable was self-perceived satisfaction using the Patient Global Impression of Improvement (PGI-I) scale. Wilcoxon rank sum test, Fisher's exact test and logistic regression were performed. (3) Results: One hundred and forty-nine consecutive patients were included, twenty-one (14%) previously treated for urethral or bladder neck stricture (seven urethroplasty, nine internal urethrotomy and five bladder neck incision). After ATOMS adjustment, 38% of the patients with treated stricture were continent compared to 83% of those without (p < 0.0001). After weighted matched observations using propensity score pairing, the proportion of continent patients without a previous stricture was 56% (p = 0.236). Complications occurred in 29% of the patients with stricture and in 20% of those without (p = 0.34). The severity of the complications was distributed evenly among the groups (p = 0.42). Regarding self-perceived satisfaction with the implant, 90% of the patients with stricture perceived the results satisfactorily (PGI-I 1-3) compared to 97% of the rest (p = 0.167). Stricture was associated with radiotherapy (p < 0.0001) and time from prostatectomy to implantation (p = 0.012). There was a moderate correlation between previous stricture and the severity of incontinence, both evaluated according to the 24-h pad test (Rho = 0.378; p < 0.0001) and the ICIQ-SF questionnaire (Rho = 0.351; p < 0.0001). Multivariate analysis for the factors predictive of failure after ATOMS adjustment revealed previous stricture (OR 4.66; 95% CI 1.2-18.87), baseline 24-h pad test (per 100 mL, OR 1.28; 95% CI 1.09-1.52) and final cushion volume (per mL, OR 1.34; 95% CI 1.19-1.55). This model predicted dryness with an AUC of 92%. After the PSMATCH procedure using a propensity score, the model remained unchanged, with the previous stricture (OR 8.05; 95% CI 1.08-110.83), baseline 24-h pad test (per 100 mL, OR 1.53; 95% CI 1.15-2.26) and final cushion volume (per mL, OR 1.45; 95% CI 1.17-2) being independent predictors and an AUC of 93%. (4) Conclusions: ATOMS can be used to treat male stress incontinence in patients with a history of stricture, although the effectiveness of the device is reduced. On the other hand, the security and perceived satisfaction were equivalent for both groups.

Project description:BackgroundUrodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.MethodsWe performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.ResultsA total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.ConclusionsFor women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Dataset Information

Modification of bladder thermodynamics in stress urinary incontinence patients submitted to trans-obturator tape: A retrospective study based on urodynamic assessment.

Publications

Modification of bladder thermodynamics in stress urinary incontinence patients submitted to trans-obturator tape: A retrospective study based on urodynamic assessment.

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