Efficacy/Safety of Midurethral Sling

Official title

Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence

Overview

The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients. Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated. This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.

Detailed description

The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min. All patients received a pre- and a post-operative urodynamic evaluation, in which pre-operative evaluation was conducted 1-4 weeks before TOT procedure, and post-operative evaluation was done at 4-6 weeks follow-up.

Complete multichannel urodynamic studies including free uroflowmetry, filling and voiding cystometry, and urethral pressure profile was performed in each patient. The urodynamic parameters measured were the maximum flow rate (Qmax), voided volume, post-void residual volume (PVR), and detrusor pressure at Qmax (Pdet. Qmax). The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline at an infusion rate of 80 ml/min. All data were recorded and analyzed using a Medical Measurement Systems (MMS UD-200, Enschede, The Netherlands). All data in this study will be expressed as mean ± SEM. After checking the normality and variance of data, two-way ANOVAs were used to assess the difference in values among testing groups and time points; and post hoc Student-Newman-Keuls tests were used to compare the means of groups when there was a significant difference between groups. Significance was set at p\<0.05.

Interventions

• Procedure Urodynamic investigations before and after a trans-obturator tape protocol.
  Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.)
• Procedure Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
  Urodynamic investigations (stated above.)
• Procedure Urodynamic investigations before and after a mini Arc protocol.
  Urodynamic investigations (stated above)
• Procedure Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
  Urodynamic investigations (stated above)
• Procedure Urodynamic investigations before and after an Solyx sling protocol.
  Urodynamic investigations (stated above.)

Primary outcome measures

• Pressure-volume study [Time frame: within a voiding cycle (a cycle is about 30 to 60 minutes)]

Eligibility criteria

Inclusion criteria

• Clinical diagnosis of stress urinary incontience
• Have urodynamic investigations before and after operation.

Exclusion criteria

• Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Department of Obstetrics and Gynecology — New Taipei City

Publications

• Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, Cardozo L, Castro-Diaz D, O'Connell PR, Cottenden A, Cotterill N, de Ridder D, Dmochowski R, Dumoulin C, Fader M, Fry C, Goldman H, Hanno P, Homma Y, Khullar V, Maher C, Milsom I, Newman D, Nijman RJM, Rademakers K, Robinson D, Rosier P, Rovner E, Salvatore S, Takeda M, Wagg A, Wagner T, Wein A; members of the committees. 6th In PMID 30106223
• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract a PMID 11857671
• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abst PMID 12559262
• Atis G, Arisan S, Ozagari A, Caskurlu T, Dalkilinc A, Ergenekon E. Tissue reaction of the rat urinary bladder to synthetic mesh materials. ScientificWorldJournal. 2009 Oct 2;9:1046-51. doi: 10.1100/tsw.2009.120. PMID 19802500
• de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003 Dec;44(6):724-30. doi: 10.1016/j.eururo.2003.09.003. PMID 14644127
• Hsiao SM, Kuo HC. Predictors of further anti-incontinence interventions or transvaginal urethrolysis after a pubovaginal sling procedure in women with and without neurologic disorders. J Formos Med Assoc. 2021 Jul;120(7):1464-1477. doi: 10.1016/j.jfma.2020.12.029. Epub 2021 Jan 16. PMID 33468403
• Huang WC, Lau HH, Su TH. Did surgical failure and complications affect incontinence-related quality of life in women after transobturator sling procedure? Taiwan J Obstet Gynecol. 2018 Apr;57(2):295-299. doi: 10.1016/j.tjog.2018.02.020. PMID 29673676
• Medina CA, Costantini E, Petri E, Mourad S, Singla A, Rodriguez-Colorado S, Ortiz OC, Doumouchtsis SK. Evaluation and surgery for stress urinary incontinence: A FIGO working group report. Neurourol Urodyn. 2017 Feb;36(2):518-528. doi: 10.1002/nau.22960. Epub 2016 Mar 7. PMID 26950893

Identifiers

NCT: NCT05255289 · 20MMHIS410e

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗