Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00647

2 Trial Registration Date

2018-12-18

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lai Loi LEE

ii Address

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

iii Phone

66839684

iv Email

loretalee@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Symphorosa Shing Chee Chan

ii Address

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

iii Phone

35052814

iv Email

symphorosa@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

RCT of laser treatment in women with SUI

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-12

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.387-T

14 Medical Condition Being Studied

Stress urinary incontinence

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

Er:YAG; infrared erbium laser

iv Dosage of the intervention

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.

v Duration of the intervention

20 mintues

vi Frequency of the intervention

2 times with 4 weeks apart

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

20 minutes

v Frequency of the comparative treatments

2 times with 4 weeks apart

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Women aged over 18

Patients diagnosed with urodynamic stress incontinence (USI)

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

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

999

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

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

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

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.

20 Anticipated trial start date

2018-12-24

21 Target Sample Size

75

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At 6 and 12 months follow up after intervention

24 Secondary Outcome

i The Name of the outcome

Symptoms of SUI according to question 20-22 of PFDI

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Symptoms of SUI according to the 3 days bladder diary

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Visual Analog Scale (VAS)

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At 6 and 12 months follow up after intervention

Secondary Outcome

i The Name of the outcome

Reduction in other domains of PFDI and PFIQ

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At 6 and 12 months follow up after intervention

Secondary Outcome

i The Name of the outcome

Reduction in ICIQ-UI SF score

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At 6 and 12 months follow up after intervention

Secondary Outcome

i The Name of the outcome

Tolerabilityof intravaginal laser treatment

ii The metric or method of measurement used

Patient's subjective pain score will be asked

iii The timepoint(s) of primary interest

After laser treatment/sham procedure.

Secondary Outcome

i The Name of the outcome

Satifactory of intravaginal laser treatment

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Complications or adverse effect of intravaginal laser treatments

ii The metric or method of measurement used

Complications and adverse event will be asked

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Anal tone and pelvic floor muscle strength by Oxford scale

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At baseline, 6 and 12 months follow up after intervention

Secondary Outcome

i The Name of the outcome

Need for surgical treatment for stress urinary incontinence

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

At 6 and 12 months follow up after intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-04-13

27 Primary Registry and Trial Identifying Number

ChiCTR1900021044

28 Date of Registration in Primary Registry

2018-12-18

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Trial History Detail on 2019-05-08