Skip to content

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

CO2 LASER and Microablative Fractionated Radiofrequency in treatment of urinary incontinence. A Randomized Controlled Trial - EPM - LARF - ARM 3 Escola Paulista de Medicina - Light amplification by stimulated emission of radiation and Radiofrequency - Arm 3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-33jphr
Enrollment
Unknown
Registered
2018-07-05
Start date
2018-08-10
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

Unspecified urinary incontinence

Interventions

Group Laser- 36 women with stress urinary incontinence (SUI) will receive a intravaginal CO2 LASER treatment once a month for 3 months, plus behavioral orientation and will also be advised to perform

Sponsors

Escola Paulista de Medicina
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Subjective improvement of SUI, defined by a score 4 and 5 of Likert scale, at 15 months after the beginning of treatment

Secondary

MeasureTime frame
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).

Countries

Brazil

Contacts

Public ContactAna Silvia Seki

Universidade Federal do Estado de São Paulo

anaseki@uol.com.br+551131710271

Outcome results

None listed

Source: REBEC (via WHO ICTRP)