Intravaginal Laser Treatment of Mild and Moderate Stress... | NCT03267719

Studies
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

NCT03267719

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 22, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Stress Incontinence, Female

Interventions

laser therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2017Actual

Primary Completion Date

Mar 1, 2018Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2024

Last Update Posted Date

Jul 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Detailed Description

The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laser therapy	Experimental	Erbium-laser therapy will be applied	Device: laser therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laser therapy	Device	Transvaginal erbium-laser treatment	laser therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life	Quality of life will be access via ICIQ-SF questionaire	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Light or moderate stress incontinence
mixed urine incontinence with predominance of the stress component
written informed consent

Exclusion Criteria:

Pregnancy
patients treated radiotherapy in the small basin
connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome)
patient with or after malignant disease of the uterus, ovaries, vagina and vulva
former surgery due to stress incontinence (except for the patients who had a TVT insert with removal of the TVT)
Descensus genitalis> POPQ Stage 1
former surgery due to a genital lowering with vaginal netting

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christl Reisenauer, Prof. Dr.	University Women's Hospital Tübingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Women's Health		Tübingen		72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided