Quality-of-Life Outcomes After Autologous Fascial Sling and TVT: a Prospective Randomized Trial
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Observational

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

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.
    

Intervention name(s): AFS and TVT
Intervention type(s): Procedure
Intervention description(s): Autologous Fascial Sling and Tension- Free Vaginal Tape
Other intervention name(s): AFS; TVT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample
      
Keywords: Randomized study; surgical treatment; autologous fascial sling; TVT; stress urinary incontinence.