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Efficacy/Safety of Midurethral Sling

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ClinicalTrials.gov Identifier: NCT05255289
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Chin-Tsung Shen, Mackay Medical College

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: Urodynamic investigations before and after a trans-obturator tape protocol. Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Before TOT
Data obtained before the operation
 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.)
Experimental: After TOT
Data obtained after the operation
 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.)


Outcome Measures
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Primary Outcome Measures :
  1. Pressure-volume study [ Time Frame: within a voiding cycle (a cycle is about 30 to 60 minutes) ]
    urine leakage.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05255289


Contacts
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Contact: Hui-Hsuan Lau, M.D. +886-975-835928 huihsuan1220@gmail.com

Locations
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Taiwan
Department of Obstetrics and Gynecology Recruiting
New Taipei City, Taiwan
Contact: Hui-Hsuan Lau, PhD    +886 975-835928    huihsuan1220@gmail.com   
Sponsors and Collaborators
Mackay Medical College
Investigators
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Study Chair: Yi-Shing Leu, M.D. Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chin-Tsung Shen, Head of administration, Mackay Medical College
ClinicalTrials.gov Identifier: NCT05255289    
Other Study ID Numbers: 20MMHIS410e
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For we uncertain if this might violate personal information laws in our country.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations