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Efficacy/Safety of Midurethral Sling

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Urodynamic investigations before and after a trans-obturator tape protocol.
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Urodynamic investigations before and after a mini Arc protocol.
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Sponsored by
Mackay Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm 30

Arm 31

Arm 32

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Before TOT

After TOT

Before TVT-O

After TVT-O

Aged patient (>50 y/o) before TVT-O

Aged patient (>50 y/o) after TVT-O

Young patients (<50 y/o) before TVT-O

Young patients (<50 y/o) after TVT-O

Menopausal patient before TVT-O

Menopausal patient after TVT-O

Pre-menopausal patient before TVT-O

Pre-menopausal patients after TVT-O

Before i-STOP

After i-STOP

Aged patient before i-STOP

Aged patient after i-STOP

Young patient before i-STOP

Young patient after i-STOP

Menopausal patient before i-STOP

Menopausal patient after i-STOP

Pre-menopausal patient before i-STOP

Pre-menopausal patient after i-STOP

Before mini Arc

After mini Arc

Age patient before mini Arc

Age patient after mini Arc

Young before mini Arc

Young patient after mini Arc

Menopausal patient before mini Arc

Menopausal patient after mini Arc

Pre-menopausal before mini Arc

Pre-menopausal patient after mini Arc

Arm Description

Data obtained before the operation

Data obtained after the operation

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Data obtained before the operation.

Data obtained after the operation.

Outcomes

Primary Outcome Measures

Pressure-volume study
urine leakage.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2022
Last Updated
August 30, 2023
Sponsor
Mackay Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05255289
Brief Title
Efficacy/Safety of Midurethral Sling
Official Title
Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Before TOT
Arm Type
Experimental
Arm Description
Data obtained before the operation
Arm Title
After TOT
Arm Type
Experimental
Arm Description
Data obtained after the operation
Arm Title
Before TVT-O
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
After TVT-O
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Aged patient (>50 y/o) before TVT-O
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Aged patient (>50 y/o) after TVT-O
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Young patients (<50 y/o) before TVT-O
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Young patients (<50 y/o) after TVT-O
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Menopausal patient before TVT-O
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Menopausal patient after TVT-O
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Pre-menopausal patient before TVT-O
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Pre-menopausal patients after TVT-O
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Before i-STOP
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
After i-STOP
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Aged patient before i-STOP
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Aged patient after i-STOP
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Young patient before i-STOP
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Young patient after i-STOP
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Menopausal patient before i-STOP
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Menopausal patient after i-STOP
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Pre-menopausal patient before i-STOP
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Pre-menopausal patient after i-STOP
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Before mini Arc
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
After mini Arc
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Age patient before mini Arc
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Age patient after mini Arc
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Young before mini Arc
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Young patient after mini Arc
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Menopausal patient before mini Arc
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Menopausal patient after mini Arc
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Arm Title
Pre-menopausal before mini Arc
Arm Type
Experimental
Arm Description
Data obtained before the operation.
Arm Title
Pre-menopausal patient after mini Arc
Arm Type
Experimental
Arm Description
Data obtained after the operation.
Intervention Type
Procedure
Intervention Name(s)
Urodynamic investigations before and after a trans-obturator tape protocol.
Intervention Description
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.)
Intervention Type
Procedure
Intervention Name(s)
Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O)
Intervention Description
Urodynamic investigations (stated above.)
Intervention Type
Procedure
Intervention Name(s)
Urodynamic investigations before and after a mini Arc protocol.
Intervention Description
Urodynamic investigations (stated above)
Intervention Type
Procedure
Intervention Name(s)
Urodynamic investigations before and after an i-STOP mini adjustable sling protocol.
Intervention Description
Urodynamic investigations (stated above)
Primary Outcome Measure Information:
Title
Pressure-volume study
Description
urine leakage.
Time Frame
within a voiding cycle (a cycle is about 30 to 60 minutes)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Hsuan Lau, M.D.
Phone
+886-975-835928
Email
huihsuan1220@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Shing Leu, M.D.
Organizational Affiliation
Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Hsuan Lau, PhD
Phone
+886 975-835928
Email
huihsuan1220@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For we uncertain if this might violate personal information laws in our country.
Citations:
PubMed Identifier
30106223
Citation
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 International Consultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol Urodyn. 2018 Sep;37(7):2271-2272. doi: 10.1002/nau.23551. Epub 2018 Aug 14. No abstract available.
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derived
Links:
URL
https://bcmj.org/sites/default/files/public/BCMJ_49_Vol9_articles_reported_complications.pdf
Description
Reported complications of tension-free vaginal tape procedures: A review

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Efficacy/Safety of Midurethral Sling

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