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Analysis of the occurrence of Urine Flow Obstruction in the recent postoperative period of patients undergoing different types of adjustments in the treatment of Urinary Incontinence. Clinical study with random choice of patients, with researchers and patients who do not know which treatment was applied

Assessing incidence of Infravesical Obstruction in early post-operative of Autologous Fascial Sling between different tensioning technics: a randomized and double blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6fzjjqx
Enrollment
Unknown
Registered
2024-03-25
Start date
2021-08-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Interventions

Fifty-six patients will be randomly chosen, with randomization through the Sealed Envelope platform, with blinding of patients and the examiner, between 2 groups of 28 patients/group, the surgeries wi

Sponsors

Hospital de Clínicas de Porto Alegre da Universidade Federal do Rio Grande do Sul - HCPA
Lead Sponsor
Hospital de Clínicas de Porto Alegre da Universidade Federal do Rio Grande do Sul - HCPA
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients from the Urology outpatient clinic of the Hospital de Clínicas de Porto Alegre; female; over 18 years of age; with failure of conservative treatment for stress urinary incontinence (behavioral therapy with or without a combination of physiotherapy or medication treatment) and agreeing to the informed consent form

Exclusion criteria

Exclusion criteria: Patients with neurogenic etiology of symptoms; previous bladder surgeries; patients with bladder lithiasis; underactive bladder; previous urinary retention and/or infravesical obstruction; interstitial cystitis; patients with urological cancers or grade > 2 vaginal prolapse; patients with severe cardiopulmonary pathologies; acute symptoms of urinary tract infection or recurrent infections; diabetes mellitus decompensated; pregnant women; patients with postoperative follow-up time less than 12 weeks

Design outcomes

Primary

MeasureTime frame
Evaluate the incidence of urinary retention after sling autologous fascial surgery (need for bladder catheterization or post-void residue > 200cc) in 2, 4 and 12 weeks, in patients with tension in the techniques with knot aponeurosis intervals of 3 and 6cm

Secondary

MeasureTime frame
To evaluate the objective and subjective cure rates of stress urinary incontinence (negative cough test and answer “No” to question 3 Inventory of Urogenital Distress - Questionnaire (UDI-6), respectively, between the two groups ;Evaluate the incidence of postoperative voiding dysfunction in relation to therapies, through the Urogenital Distress Inventory - Questionnaire (UDI-6) Evaluate the overall satisfaction rate in relation to therapies;Evaluate the frequency of adverse events between the two techniques: urinary tract infection, severe pain, need for sling section;Evaluate the overall satisfaction rate in relation to therapies, using a visual analogue scale

Countries

Brazil

Contacts

Public ContactTiago Bortolini

Hospital de Clínicas de Porto Alegre

secretariageral@hcpa.edu.br+55-51-33598000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)