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A randomized controlled trial of laser treatment in women with stress urinary incontinence

A randomized controlled trial of laser treatment in women with stress urinary incontinence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021044
Enrollment
Unknown
Registered
2018-12-18
Start date
2018-12-24
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

women with stress urinary incontinence

Interventions

Two groups:Laser therapy with two phases 20 minutes 2 times with 4 weeks apart versus Sham procedure with zero intensity settings 20 minutes 2 times with 4 weeks apart

Sponsors

Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged over 18 years; 2. Patients diagnosed with urodynamic stress incontinence (USI); 3. Willing to give written consent and compliance to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with mixed urinary incontinence with predominant urge urinary incontinence; 2. Patients who had recurrent USI that failed previous surgical treatment, e.g. tension free vaginal tape surgery or injection of bulking agent; 3. Patients with pregnancy or lactating; 4. Patients with stage II or above pelvic organ prolapse; 5. Patients with undiagnosed vaginal bleeding, injury or active infection; 6. Patients currently in-use of photosensitive drugs; 7. Patients refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
Reduction in PFDI Urinary Distress Inventory Stress Subscale scores between both groups;—

Secondary

MeasureTime frame
Symptoms of SUI according to question 20-22 of PFDI;Symptoms of SUI according to the 3 days bladder diary;Visual Analog Scale (VAS);Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups;Reduction in other domains of PFDI and PFIQ;Reduction in ICIQ-UI SF score;Tolerabilityof intravaginal laser treatment;Satifactory of intravaginal laser treatment;Complications or adverse effect of intravaginal laser treatments;Anal tone and pelvic floor muscle strength by Oxford scale;Need for surgical treatment for stress urinary incontinence;—

Countries

China

Contacts

Public ContactSymphorosa Shing Chee Chan

Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Chinese University of Hong Kong

symphorosa@cuhk.edu.hk+852 35052814

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026