Quality-of-Life Outcomes After Autologous Fascial Sling and TVT: a Prospective Randomized Trial
NCT ID: NCT00565838
Last Updated: 2007-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2001-01-31
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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2
G1 - Autologous Fascial Sling G2 - TVT
AFS and TVT
Autologous Fascial Sling and Tension- Free Vaginal Tape
Interventions
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AFS and TVT
Autologous Fascial Sling and Tension- Free Vaginal Tape
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
FEMALE
No
Sponsors
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UPECLIN HC FM Botucatu Unesp
OTHER
Responsible Party
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International Continence Society
Principal Investigators
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João L Amaro, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology - UNESP
Locations
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Medical School of Medicine
Botucatu, São Paulo, Brazil
Countries
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Other Identifiers
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upeclin/HC/FMB-Unesp-05
Identifier Type: -
Identifier Source: org_study_id