Comparison of low-energy radiofrequency thermal vaginal therapy vs. sham for female stress urinary incontinence: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20181115004

Enrollment

Registered

2018-11-15

Start date

2018-11-19

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Female stress urinary incontinence Female stress urinary incontinence radiofrequency non&#45

Interventions

Low&#45

energy radiofrequency thermal vaginal therapy (the Viveve System) group will receive the treatment followed SUI protocol. 220 pulses in total of radiofrequency divided into 110 pulses using 5cm tip an

the first position will be applied at distal edge of treatment tip 2 cm beyond hymenal ring &#45

100 pulses &#45

5 pulses/quadrant &#45

5 passes &#45

25 pulses/quadrant The second position will be applied at distal edge of treatment tip 3 cm beyond hymenal ring &#45

25 pulses/quadrant The third position will be placed at the distal edge of treatment tip 4 cm beyond hymenal ring &#45

10 pulses &#45

5 pulses right side of urethra &#45

5 pulses left side of urethra &#45

1 pass The fourth Position will be placed at the distal edge of treatment tip 5 cm beyond hymenal ring &#45

1 pass ,Assignment to either low&#45

energy radiofrequency thermal vaginal therapy (the Viveve System) or sham will be blinded to the evaluator and subjects.

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria - Postmenopausal women aged â‰¥ 50 years who suffers from mild to moderate SUI - Last menstrual period more than 1 year - Positive Q-tip test - Never received transvaginal laser or radiofrequency treatment - Never undergone anti-incontinence procedures - Did not use vaginal estrogen within 3 months - Informed consent

Exclusion criteria

Exclusion criteria: Pelvic organ prolapse of anterior compartment stage 3 and 4 - Urinary retention - obesity (body mass index >35 kg/m2) - Urinary tract infection - Severe SUI which illustrated with more than 2 pads used per day or 1-hour pad test more than 50 mL/h - Photosensitivity - Using HRT - Had contraindication for estrogen - Undiagnosed abnormal vaginal bleeding - Taking corticosteroid, or immunosuppresants

Design outcomes

Primary

Measure	Time frame
female stress urinary incontinence pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment 1-hour pad test	—

Secondary

Measure	Time frame
voiding diary pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment number and severity of SUI per day, number of pad/day,quality of life outcome by questionnaires pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment IQOL, IIQ-7, and PGI-I,Adverse events pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment incidence of adverse events related to treatment	—

Measure

Time frame

voiding diary pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment number and severity of SUI per day, number of pad/day,quality of life outcome by questionnaires pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment IQOL, IIQ-7, and PGI-I,Adverse events pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment incidence of adverse events related to treatment

—

Countries

Thailand

Contacts

Public ContactOrawee Chinthakanan

Ramathibodi Hospital, Mahidol University

orawee.chi@mahidol.edu+66819522215

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Comparison of low&#45;energy radiofrequency thermal vaginal therapy vs. sham for female stress urinary incontinence: a randomized controlled trial