Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Rambam Health Care Campus

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Device: Sham laser; Device: Erbium laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04636749

0379-20-RMB-CTIL

Details and patient eligibility

About

Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.

Full description

Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.

Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.

The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.

The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.

The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.

In this study we desire to examine the effect of vaginal ERBIUM treatment on SUI in compare to placebo.

this is a randomized single blind control trial. 40 women will be included in the research group and 40 in the placebo group. Women will be assigned randomly to each group. They will be treated with vaginal laser probe, three treatments 4 weeks apart. Follow up visits will be performed 3, 6, and 12 months after the first treatment.

Effectiveness evaluation will be done by physical urodynamic examination before treatment and 6 month after finishing, by 24 hours pad test' cough test and by fulfilling questionnaires-

1. The Urogenital Distress inventory (UDI6)
2. The Female Sexual Function Index (FSFI)

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

women above 18 with SUI -

Exclusion criteria

1. Recurrent pelvic inflammatory disease
2. Vaginal operation in the previous year
3. Women with abnormal uterine bleeding
4. Women with diagnosed genital herpes infection
5. Any concurrent lower genital tract infection -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Erbium laser

Active Comparator group

Description:

Treatment with Erbium laser

Treatment:

Device: Erbium laser

Sham laser

Sham Comparator group

Description:

Treatment with sham laser

Treatment:

Device: Sham laser