Co2 LASER and Microablative Fractionated Radiofrequency in treatment of urinary incontinence. A Randomized Controlled Trial

Not Applicable

• Conditions: nspecified urinary incontinence; N00-N99

• Registration Number: RBR-33jphr
• Lead Sponsor: Escola Paulista de Medicina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-05
• Study Completion: 2020-12-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Age between 30 and 75 years; main clinical complaint of stress incontinence urinary confirmed by clinical examination; absence of genital prolapse or prolapse stage more than II, where the prolapse reaches the maximum of the himenal ring and point Ba less than or equal to zero; no use of local estrogen therapy for at least 6 months; negative culture of urine; absence of previous surgical treatment of SUI or colpoplasty; absence of predominant urgency symptom; absence of active infection by HPV or genital herpes; absence of abnormal genital bleeding; absence of antecedent of genital neoplasia or current genital neoplasia; absence of Neurogenic Bladder; absence of pregnancy or puerperium

Exclusion Criteria

Age below 30 years and above 75 years; presence of genital prolapse grade 2 that exceeds himenal ring, or grades 3 and 4; previous surgical treatment for stress incontinence urinary; overactive bladder; neurogenic bladder

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective improvement of SUI, defined by a score 4 and 5 of Likert scale, at 15 months after the beginning of treatment<br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
Objective cure of SUI defined as negative stress-test, negative pad-test and absence of report of urinary leakage in the 7 days voiding diary, at 15 months after the beginning of treatment;Evaluation of frequency of urinary loss in sexual intercourse, at 15 months after the beginning of treatment;Evaluation of frequency of urgency and noturna, at 15 months after the beginning of treatment;Determination of lasting of objective cure and subjective improvement of SUI, after treatment, by semestral follow-up with stress test, 1h pad-test, voiding diary, LIKERT Scale, quality of life questionnaires ( ICIQ-SF, IQoL, FSF-I).