Clinical Trials Logo
  1. Home
  2. Stress Urinary Incontinence
  3. NCT03479996
  4. Details
NCT03479996 Clinical Trial

Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

Stress Urinary Incontinence Clinical Trial

Official title:
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03479996
Other study ID # BRZ 0005-18 CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 13, 2018
Est. completion date June 22, 2020

Study information
Verified date July 2020
Source Barzilai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

BACKGROUND:

Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the anesthetic substance will be injected versus the inner part of of the thigh without anesthetic injection in the same woman.

The advantage of this work is that this method of testing neutralizes the effect of pain thresholds of different women.

If an advantage will be found in injecting anesthetic as a reduction in postoperative pain, it could be recommended for all women who undergo surgery of this kind.

METHODS:

Preoperative women will be offered the opportunity to participate in the study after a detailed explanation of the study and determine a date for an elective TVT-O procedure. After signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be injected into a left or right obturator membrane.

One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without injection of any anesthetic.

Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of the thigh separately. Each patient will rate the intensity of the pain she feels on the pain questionnaire at each of the time points mentioned before.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date June 22, 2020
Est. primary completion date June 22, 2020
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria:

• Women undergoing TVT-O

Exclusion Criteria:

• Repeat surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Marcaine 0.5 % Injectable Solution
Intra -operative injection into obturator membrane

Locations
Country Name City State
Israel Barzilay University Medical Center Ashkelon

Sponsors (1)
Lead Sponsor Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Cheng D, Liu C. Tension-free vaginal tape-obturator in the treatment of stress urinary incontinence: a prospective study with five-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2012 Apr;161(2):228-31. doi: 10.1016/j.ejogrb.2012.01.011. Epub 2012 Feb 13. — View Citation

Duckett J, Baranowski A. Pain after suburethral sling insertion for urinary stress incontinence. Int Urogynecol J. 2013 Feb;24(2):195-201. doi: 10.1007/s00192-012-1863-3. Epub 2012 Jul 3. Review. — View Citation

Hazewinkel MH, Hinoul P, Roovers JP. Persistent groin pain following a trans-obturator sling procedure for stress urinary incontinence: a diagnostic and therapeutic challenge. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Mar;20(3):363-5. doi: 10.1007/s00192-008-0714-8. Epub 2008 Sep 4. — View Citation

Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG. 2007 May;114(5):522-31. Epub 2007 Mar 16. Review. Erratum in: BJOG. 2007 Oct;114(10):1311. — View Citation

Tommaselli GA, Di Carlo C, Formisano C, Fabozzi A, Nappi C. Effect of local infiltration analgesia on post-operative pain following TVT-O: a double-blind, placebo-controlled randomized study. Arch Gynecol Obstet. 2014 Aug;290(2):283-9. doi: 10.1007/s00404-014-3186-8. Epub 2014 Mar 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Leg pain VAS score 1 hour after surgery
Primary Leg pain VAS score 6 hours after surgery
Primary Leg pain VAS score 12 hours after surgery
Primary Leg pain VAS score 24 hours after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1