Clinical trial NCT04636749: Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence
Official title: Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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 -

Primary outcomes:
measure: Cough test
timeFrame: From enrollment up to 12 months post treatment
measure: Pad test
timeFrame: From enrollment up to 12 months post treatment
Secondary outcomes:
measure: Urinary distress index 6
timeFrame: From enrollment up to 12 months post treatment
measure: Female sexual function
timeFrame: From enrollment up to 12 months post treatment
measure: Urinary incontinence and sexuality
timeFrame: From enrollment up to 12 months post treatment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Naama Farago, MD
role: PRINCIPAL_INVESTIGATOR
References:
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