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Trial Detail

CUHK_CCRB00647

2018-12-18

Prospective

N/A

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

N/A

Not Applicable

Lai Loi LEE

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hosptial, Shatin, N.T., Hong Kong

66839684

loretalee@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Symphorosa Shing Chee Chan

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hosptial, Shatin, N.T., Hong Kong

35052814

symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

激光療法用於處理華人婦女壓力性小便失禁問題之隨機研究

RCT of laser treatment in women with SUI

Hong Kong

Yes

2018-10-12

Joint CUHK-NTEC Clinical Research Ethics Committee

2018.387-T

Stress urinary incontinence

Procedure

Laser therapy with two phases.

In the first phase, Ablative fractional treatment using GYN C Mode will be adopted. In the second phase, Thermal treatment using GYN W Mode will be adopted.

Er:YAG; infrared erbium laser

In first phase, GYN C Mode refers to fluence 5-35 J/cm2, pulse length 300 μs, interval 0.5-2 seconds and handpiece rotation of 45 degree (line to line on the handpiece). In second phase, GYN W Mode refers to fluence 6-12 J/cm2, pulse length 1000 μs, interval 0.5-2 seconds.

20 mintues

2 times with 4 weeks apart

Sham procedure with zero intensity settings, without receiving therapeutic irradiation.

N/A

N/A

20 minutes

2 times with 4 weeks apart

Women aged over 18

Patients diagnosed with urodynamic stress incontinence (USI)

Willing to give written consent and compliance to participate in the study

Patients with mixed urinary incontinence with predominant urge urinary incontinence

Patients who had recurrent USI that failed previous surgical treatment, e.g. tension free vaginal tape surgery or injection of bulking agent

Patients with pregnancy or lactating

Patients with stage II or above pelvic organ prolapse

Patients with undiagnosed vaginal bleeding, injury or active infection

Patients currently in-use of photosensitive drugs

Patients refuse to participate in the study

18

999

Female

Interventional

Randomized

Permuted-block randomization in 2:1 ratio of treatment group:control group, with block size of 3

Placebo

Single-blind

Trial subjects

Parallel

Other

N/A

To compare the efficacy of vaginal laser treatment for women with SUI as compared to control, based on reduction in scores on health related quality of life (PFDI-UDI Stress Subscale), subjective outcome of symptoms improvement, urinary diary, VAS, other scores of health related quality of life.

2018-12-24

75

Recruiting

Reduction in PFDI Urinary Distress Inventory Stress Subscale scores between both groups

Self-answer questionniare PFDI will be completed by subjects. Reduction of scores between two groups will be compared .

At 6 and 12 months follow up after intervention

Symptoms of SUI according to question 20-22 of PFDI

Self-answer questionniare PFDI will be completed by subjects and symptoms of SUI will be investigated

At first visit, 6 and 12 months follow up after intervention

Symptoms of SUI according to the 3 days bladder diary

3 days bladder diary will be completed by subjects, and symptoms of SUI will be investigated

At first visit, 6 and 12 months follow up after intervention

Visual Analog Scale (VAS)

Visual analog scale questionnaire will be completed by subjects and score will be measured

At first visit, 6 and 12 months follow up after intervention

Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups

Self-answer questionniare PFIQ will be completed by subjects. Reduction of scores between two groups will be compared

At 6 and 12 months follow up after intervention

Reduction in other domains of PFDI and PFIQ

Self-answer questionniare PFDI and PFIQ will be completed by subjects. Reduction of domain scores will be calculated

At 6 and 12 months follow up after intervention

Reduction in ICIQ-UI SF score

Self-answer questionniare ICIQ-UI SF will be completed by subject. Reduction of scores will be calculated

At 6 and 12 months follow up after intervention

Tolerabilityof intravaginal laser treatment

Patient's subjective pain score will be asked

After laser treatment/sham procedure.

Satifactory of intravaginal laser treatment

Patients' subjective outcome as “much better”, “somewhat better”, “stay the same”, “somewhat worse” or “much worse” are asked

At 4 week, 3, 6 and 12 months follow up after intervention

Complications or adverse effect of intravaginal laser treatments

Complications and adverse event will be asked

During and after laser treatment/sham procedure, at 6 and 12 months follow up after intervention

Anal tone and pelvic floor muscle strength by Oxford scale

Anal tone, pelvic floor muscle strenght will be assed by doctors

At baseline, 6 and 12 months follow up after intervention

Need for surgical treatment for stress urinary incontinence

Subject will be followed-up and any surgical treatment will be recorded

At 6 and 12 months follow up after intervention

No

2020-05-13

ChiCTR1900021044

2018-12-18

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