Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04636749
Study type	Interventional
Source	Rambam Health Care Campus
Contact	Naama Farago, MD
Phone	972-509267806
Email	n_farago@rmc.gov.il
Status	Recruiting
Phase	N/A
Start date	March 9, 2021
Completion date	October 22, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04829357` - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed	`NCT05493735` - Lidocaine for Pessary Check Pain Reduction	Phase 3
Completed	`NCT04512053` - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence	Phase 2
Active, not recruiting	`NCT06224335` - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting	`NCT05304312` - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women	N/A
Not yet recruiting	`NCT05527665` - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting	`NCT04558762` - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn	`NCT02524366` - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement	N/A
Completed	`NCT01924728` - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence	N/A
Completed	`NCT01676662` - Solace European Confirmatory Trial	N/A
Unknown status	`NCT01455779` - Lyrette: Renewing Continence Objective and Subjective Efficacy Study	N/A
Terminated	`NCT01029106` - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)	N/A
Completed	`NCT01770691` - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence	N/A
Completed	`NCT01123096` - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?	N/A
Withdrawn	`NCT00573703` - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence	Phase 4
Completed	`NCT00234754` - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women	N/A
Completed	`NCT00441454` - Retropubic vs. Transobturator Tension-free Vaginal Tape	N/A
Completed	`NCT03985345` - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.	N/A
Active, not recruiting	`NCT03671694` - Laser Vaginal Treatment for SUI	N/A
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.