Quality-of-Life Outcomes After Autologous Fascial Sling and TVT: a Prospective Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565838
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Information provided by:
UPECLIN HC FM Botucatu Unesp

Brief Summary:
The objective of the study was to evaluate the impact AFS and TVT procedures on quality-of-life in incontinent women.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Procedure: AFS and TVT

Detailed Description:

Between January 2001 to March 2002, 41 women with a principal complaint of stress urinary incontinence were studied in a prospective trial. Based on results of no numerical variables (including patient's perception of improvement and satisfaction with treatment), the statistical test demonstrated the need for equal sized groups for the comparison. So, the total size of sample groups was previously established as at least 40 women.

These patients were randomly distributed, in a single-blind study, into two groups. Group G1 (n=21) was submitted to AFS and Group G2 (n=20) to TVT implant. Average age in G1 was 49 years (range 26-69), and in G2, 52 years (range 26-79). This study was approved by the Bioethics Commission of the School of Medicine - UNESP, Botucatu.

All the women underwent preoperative urodynamic study, using a Dynograph R.611 recorder, which confirmed stress urinary incontinence in all of them. Patients with involuntary detrusor contractions or preexisting bladder outlet obstruction (BOO) during urodynamic study were excluded of the study.

The clinical follow up and a subjective success rate was performed at 1, 6, and 12 months and then annually after hospital discharge. A questionnaire was used to obtain personal data, obstetric, gynecologic, family history, and subjective analysis of urine loss. Cure was defined as complete dryness with no usage of pads.

De novo urgency was considered when patients had no problem with urgency symptoms preoperatively presented these complaints after surgery persisting more than 1 month. These symptoms were based on clinical evaluation.

Long-term patients' satisfaction and impact on QoL were performed at 36 months after surgery. To evaluate the QoL a validated questionnaire (11) (King's Health Questionnaire) was used. Follow up range from 36 to 54 months (median: 44 months).

Body mass index (BMI) was calculated and classified according to Garrow. All patients underwent physical examination including stress test. The degree of pelvic organ prolapse was assessed and graded according to Baden et al.

Basal laboratory investigations (serum creatinine, complete blood count, chemical and microscopic urinalysis, urine culture) were all routinely performed. In exceptional cases (lithiasis history, urinary infection ) renal ultrasound and plain x-ray of the kidney, ureters and bladder were carried out.

In the immediate postoperative, endovenous tramadol (10 mg/mL-1) was used in patient controlled analgesia (PCA) pump. After an i.v. loading dose of 0.07 mL/Kg-1 (administered over a period of 30 min).

The Physiotherapy Service at each surgical procedure was responsible for carrying out the random assignment of patients in accordance with the casualty.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical and Quality-of-Life Outcomes After Autologous Fascial Sling and Tension-Free Vaginal Tape: a Prospective Randomized Trial
Study Start Date : January 2001
Actual Study Completion Date : November 2007

Group/Cohort Intervention/treatment
G1 - Autologous Fascial Sling G2 - TVT
Procedure: AFS and TVT
Autologous Fascial Sling and Tension- Free Vaginal Tape
Other Names:
  • AFS
  • TVT

Primary Outcome Measures :
  1. Primary outcome [ Time Frame: Observational ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • Stress Urinary Incontinence

Exclusion Criteria:

  • Detrusor obstruction or hyperactivity

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 identifier (NCT number): NCT00565838

Medical School of Medicine
Botucatu, SP, Brazil, 18618-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Principal Investigator: João L Amaro, PhD MD Department of Urology - UNESP

Responsible Party: João Luiz Amaro/ Associate Professor, International Continence Society Identifier: NCT00565838     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-05
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Randomized study
surgical treatment
autologous fascial sling
stress urinary incontinence.

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders