TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

• Register: ClinicalTrials.gov
• Last refreshed on: 4 September 2023
• Main ID: NCT00463554
• Date of registration: 18/04/2007
• Prospective Registration: No
• Primary sponsor: Ethicon, Inc.
• Public title: TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
• Scientific title: An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
• Date of first enrolment: April 1, 2006
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00463554
• Study type: Observational

Countries of recruitment

Finland, Italy, United States

Contacts

• Name: David Robinson, MD
• Affiliation: Ethicon, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must be female with objective, demonstratable signs of SUI or stress predominant mixed
incontinence and requires elective, primary surgical intervention.

- Must be at least 21 years old.

- Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile
(bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of
pregnancy) or has a negative pregnancy test prior to study entry and has decided to
cease childbearing.

- Agrees to participate in the study, including all study related procedures and
evaluations and documents this agreement by signing the IRB/EC-approved informed
consent

Exclusion Criteria:

- Have any other coexistent pathology requiring concomitant surgery that may impact this
procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior
colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be
performed prior to the GYNECARE TVT SECUR System surgery.

- Have intrinsic sphincter deficiency (ISD) [Urethral Pressure Profile (UPP) with a
maximum urethral closing pressure (MUCP) < 20cm H2O or Leak Point Pressure (LPP) <
60].

- Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.

- Have a fixed urethra (< 30° mobility on Q-Tip Straining Test).

- Have had prior incontinence surgery.

- Have a post-void residual volume > 100mL.

- Have co-existent pelvic organ prolapse that is symptomatic or extends beyond the
hymen.

- Have lower urinary tract pathology in the form of a fistula or diverticulum.

- Have a malignancy or with a history of malignancy within the past 5 years, except for
a basal cell carcinoma that has been treated with local excision and is no longer
present.

- Are on anticoagulant therapy.

- Have received an experimental drug or used an experimental medical device within 30
days prior to the planned start of treatment.

- Are deemed by the investigator as medically unfit for surgery or who in the opinion of
the investigator should not be enrolled in the study because of the precautions,
warnings or contraindications outlined in the GYNECARE TVT SECUR System IFU.

- Employees of the investigator or study center with direct involvement in the proposed
study or other studies under the direction of that investigator or study center.



Age minimum: 21 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Stress Urinary Incontinence

Intervention(s)

Device: GYNECARE TVT-SECUR* System

Primary Outcome(s)

Clinical performance of TVT-SECUR* [Time Frame: Screening and Day 35]

Secondary Outcome(s)

Operative time [Time Frame: Intraoperative]

Urodynamics [Time Frame: Screening, Week 5, Months 6 and 12 (post-operative optional)]

Assessment of the results of the standing cough stress test [Time Frame: Screening, Week 5, Months 6 and 12]

QoL measures [Time Frame: Screening, Week 5, Months 6 and 12]

Subject satisfaction. [Time Frame: Month 12]

Anesthesia [Time Frame: intraoperative]

Intra- and post-operative complications [Time Frame: Intraoperative, Week 5, Months 6 and 12]

Physician questionnaire results [Time Frame: Months 2 and 12]

Secondary ID(s)

300-05-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors