Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.

NCT ID: NCT03630406

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-08-31

Brief Summary

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Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.

Detailed Description

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Patients will be recruited and sign a consent form. The patients included are patients with SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4 weeks apart.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* Before the first treatment session (baseline).
* Before and after each treatment session.
* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Conditions

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Laser Burn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laser treatment

Female patients with either SUI of vaginal wall weakness and prolapse refered for an attempt at laser treatment.

Vaginal Tactile Imaging

Intervention Type DIAGNOSTIC_TEST

Vaginal Tactile Imaging

Interventions

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Vaginal Tactile Imaging

Vaginal Tactile Imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion Criteria

* Women that are not in the age range.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ROY LAUTERBACH MD

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0022-18-RMB

Identifier Type: -

Identifier Source: org_study_id

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