Stress Incontinence, FemalelaserNCT03267719
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
A study testing laser therapy in people with Stress Incontinence, Female, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Incontinence, Female
- What is being tested?
- laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Light or moderate stress incontinence
- mixed urine incontinence with predominance of the stress component
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Incontinence, Female
- Being tested
- laser therapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyDevice
Transvaginal erbium-laser treatment
| Study group | Role | What they receive |
|---|---|---|
| laser therapy | Experimental | Erbium-laser therapy will be applied Receives: Device: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life will be access via ICIQ-SF questionaire
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start31 Aug 2017
- Primary completion1 Mar 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christl Reisenauer, Prof. Dr., Principal investigator, University Women's Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267719
- Sponsor's protocol ID
- Uro-Laser
- Acronym
- laser
- Status last verified
- Mar 2019
- First submitted
- 28 Aug 2017
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
- ClinicalTrials.gov ID
- NCT03267719
- Acronym / sponsor ID
- laser / Uro-Laser
- Conditions
- Stress Incontinence, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laser therapy | Experimental | Device: laser therapyErbium-laser therapy will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Light or moderate stress incontinence
- mixed urine incontinence with predominance of the stress component
- written informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser therapyTransvaginal erbium-laser treatment | Device | laser therapy |
Primary outcome
Quality of life
Time frame: 6 month
Quality of life will be access via ICIQ-SF questionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christl Reisenauer, Prof. Dr. principal investigator
University Women's Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy in people with Stress Incontinence, Female, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.