Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05097456
Other study ID # 0292-20-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.


Description:

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date December 31, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - Negative urine analysis. - Normal Pap smear test from the recent 3 years. - No previous gynecological laser treatments. - Able and willing to comply with the treatment/follow-up schedule and requirements. Exclusion Criteria: - Active genital infection. - Subject presenting abnormal Pap result from the last three years. - Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year). - Transvaginal mesh implant. - Serious systemic disease or any chronic condition that could interfere with study compliance. - Any vaginal bleeding of unknown reason.

Study Design


Intervention

Device:
carbon dioxide laser
carbon dioxide laser
sham laser
sham laser

Locations

Country Name City State
Israel Rambam health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pad weight test Change in pad weight From treatment up to 12 months post treatment
Secondary Cough test Positive cough test From treatment up to 12 months post treatment
Secondary Urinary distress index questionnaire Change in urinary distress index questionnaire scores From treatment up to 12 months post treatment
Secondary International consultation on incontinence questionnaire-urinary incontinence Change in international consultation on incontinence questionnaire-urinary incontinence scores From treatment up to 12 months post treatment
Secondary Pelvic organ prolapse/urinary incontinence sexual questionnaire Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores From treatment up to 12 months post treatment
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
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
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