Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

March 9, 2021 updated by: Naama Farago MD, Rambam Health Care Campus

Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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)

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erbium laser
Treatment with Erbium laser
Device: Erbium laser
Vaginal laser therapy
Sham Comparator: Sham laser
Treatment with sham laser
Device: Sham laser
Sham laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough test
Time Frame: From enrollment up to 12 months post treatment
Results of full bladder cough test
From enrollment up to 12 months post treatment
Pad test
Time Frame: From enrollment up to 12 months post treatment
Results of 24 hour pad weighing test
From enrollment up to 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary distress index 6
Time Frame: From enrollment up to 12 months post treatment
Results of Urinary distress index 6 questionnaire
From enrollment up to 12 months post treatment
Female sexual function
Time Frame: From enrollment up to 12 months post treatment
Results of female sexual function index questionnaire
From enrollment up to 12 months post treatment
Urinary incontinence and sexuality
Time Frame: From enrollment up to 12 months post treatment
Results of urinary incontinence and sexuality questionnaire
From enrollment up to 12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Naama Farago, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Anticipated)

October 22, 2022

Study Completion (Anticipated)

October 22, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0379-20-RMB-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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