Laserhoito urogenitaalisten oireiden hoitoon naisilla
maanantai 29. kesäkuuta 2026 päivittänyt: Kenneth M Peters, MD, Corewell Health East
Emättimen fraktiaalinen hiilidioksidilaserhoito naisten virtsa- ja sukuelinten oireiden hoitoon
Tämä on prospektiivinen havainnointitutkimus naisista, jotka saavat emättimen hoitoa fraktionaalisella hiilidioksidilaserilla (fCO2) erilaisten urogenitaalisten oireiden vuoksi.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Emättimen kudoksen fraktio-hiilidioksidilla (fCO2) -laserhoitoa on ehdotettu erilaisten virtsaelinten oireiden hoitoon, mukaan lukien emättimen kutina, polttaminen, kuivuus, dyspareunia (vaikea tai kivulias sukupuoliyhdyntä), dysuria (kivulias tai vaikea virtsaaminen), nokturia ( herääminen öisin virtsaamaan), inkontinenssi (tahaton virtsan poisto), virtsaamistiheys, virtsaamispakko ja virtsatieinfektio (UTI).
Tapausraportti ja tapaussarjatiedot viittaavat siihen, että potilaat sietävät hyvin emättimen kudosten laserhoitoa, eikä se aiheuta vakavia riskejä potilaalle. Useat tapaussarjat osoittavat parannuksia vulvovaginaalisissa ja virtsatieoireissa sekä seksuaalisessa toiminnassa. Nämä tutkimukset ovat kuitenkin muutamasta valituista keskuksista, ovat pieniä ja ovat myös puolueellisia siinä mielessä, että laserhoito on saatavilla vain potilaille, jotka voivat maksaa siitä. Lisäksi useimmat tutkimukset raportoivat vain vulvovaginaalisista oireista huolimatta laserin käytön lisääntymisestä virtsatieoireiden hoitoon. Useat viimeaikaiset pääkirjoitukset ovat vaatineet suurempia tutkimuksia, joissa on pidempi seuranta ja korkealaatuiset tulosmittaukset. Tämä tutkimus on suunniteltu vastaamaan näihin tarpeisiin.
Tämä on prospektiivinen havainnointitutkimus naisista, jotka saavat emätinhoitoa fCO2-laserilla, ja se on tarkoitettu laajalle joukolle potilaita, joilla on vulvovaginaalisia, seksuaalisia ja/tai urologisia vaivoja. FCO2-hoidon vaikutuksia arvioidaan erilaisilla fysikaalisilla arvioinneilla ja potilaskyselyillä.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
100
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Michigan
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Royal Oak, Michigan, Yhdysvallat, 48073
- Corewell Health William Beaumont University Hospital
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 90 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Naiset, jotka täyttävät kaikki osallistumiskriteerit ja eivät ole poissulkemiskriteereitä, voidaan ottaa mukaan tutkimukseen.
Kuvaus
Sisällyttämiskriteerit:
- Nainen
- 18 vuotta tai vanhempi ja 90 vuotta tai vähemmän
Yksi tai useampi seuraavista käyttöaiheista fCO2-laserhoitoon:
- Vaihdevuosien sukuelinten oireet, mukaan lukien luonnollisen, lääketieteellisen tai kirurgisen vaihdevuosien jälkeen
- Emättimen kuivuus, polttaminen, kutina tai dyspareunia, joka ei liity vaihdevuosiin
- Stressi-inkontinenssi
- Toistuvat virtsatieinfektiot (UTI), jotka määritellään 4 tai useammaksi vuodessa
- Yliaktiivinen virtsarakko
- Tietoinen suostumus on allekirjoitettava
- On oltava valmis noudattamaan tutkimusprotokollaa
Poissulkemiskriteerit:
Vasta-aiheet fCO2-laserhoidolle, kuten:
- Tällä hetkellä istutettu synteettinen lantion verkko, kantohihna tai teippi
- Nykyiset tai aiemmat sukuelinten syövät
- Säteily emättimen tai paksusuolen kudokseen
- Tällä hetkellä raskaana tai alle 3 kuukautta raskauden jälkeen
- Diagnosoimattomat emättimen tai kohdunkaulan leesiot
- Potilaat, jotka ovat saaneet emättimen fCO2-laserhoitoa viimeisten 12 kuukauden aikana
- Potilaat, joita on hoidettu emättimen estrogeenilla viimeisen 3 kuukauden aikana
- Potilaat, joilla on diagnosoimaton emättimen verenvuoto
- Aktiivinen ulkosynnyttimen tai emättimen infektio, mukaan lukien herpes, kandidiaasi jne.
- Nykyinen virtsatieinfektio (UTI), joka on vahvistettu positiivisella virtsaviljelyllä ja potilaan ilmoittamilla oireilla
- Lantion tai emättimen leikkaus viimeisten 9 kuukauden aikana
- Lantion elimen prolapsi introituksen ulkopuolelle
- Potilaalla on muita ominaisuuksia, jotka tutkijan arvion mukaan eivät sovellu hoitoon ja/tai tutkimukseen (eli voivat lisätä potilaan riskiä, vaikuttaa tutkimuksen suorittamiseen jne.)
- Osallistuminen tutkimustutkimukseen, jossa käytettiin tutkimushoitoa, lääkitystä ja/tai biologista lääkettä 6 kuukautta tai vähemmän ennen seulontakäyntiä
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Tulevaisuuden
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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fCO2 Laser Therapy Group
Naiset hoidettiin fCO2-laserilla
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Tutkimukseen osallistuvat naiset saavat kolme hoitoa fraktiohiilidioksidilaserilla (fCO2).
Hoitokertojen välinen tauko on noin kuusi viikkoa.
Emättimensisäiset laserhoidot toimitetaan 8 kohtaan emättimen seinämän kullakin tasolla.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Potilaan yleisvaikutelma parantumisesta (PGI-I) -pisteet 4 viikkoa aloitushoidon jälkeen
Aikaikkuna: 4 viikkoa aloitushoidon jälkeen
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PGI-I-pisteet kirjataan 4 viikkoa hoidon aloittamisen jälkeen.
PGI-I pyytää potilasta "valitsemaan ruutuun, joka parhaiten kuvaa virtsa- ja/tai emätinoireesi nyt verrattuna siihen, millaisia oireita sinulla oli ennen tämän tutkimuksen aloittamista."
On 7 mahdollista vastausta, jotka vaihtelevat 1-7, joissa 1 on "Paljon parempi", 2 on "Paljon parempi", 3 on "Hieman parempi", 4 on "Ei muutosta", 5 on "Hieman huonompi". 6 on "Paljon huonompi" ja 7 on "Hyvin paljon huonompi".
Pistemäärä 1-3 merkitsisi parannusta.
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4 viikkoa aloitushoidon jälkeen
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment
Aikaikkuna: 6 months post-initial treatment
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The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment.
The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment."
There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse".
A lower score would represent improvement and a favorable outcome.
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6 months post-initial treatment
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Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present.
Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall.
The total VHIS score is a sum of the individual scores of these 5 vaginal parameters.
The minimum score is 5 and the maximum score is 25.
A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal healthy vaginal tissue.
For this outcome measure we reported the change in VHIS between 6 months and baseline.
A positive number means that vaginal tissue is healthier at 6 months compared to baseline.
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6 months post-initial treatment
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Change in Urinary Symptoms Specifically Stress Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI).
This outcome measure is focused on the SUI score only (QUID-SUI).
Patients are asked how often they leak urine in three different situations.
Responses range from 0 = none of the time, to 5 = all of the time.
The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g.
cough, lifting, exercise).
Here we report the change in QUID-SUI score from 6 months to baseline.
A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 6 months compared to baseline.
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6 months post-initial treatment
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Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months After Initial Treatment.
Aikaikkuna: 6 months post-initial treatment
|
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.
In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions.
Each question asks about the level of bother related to a specific symptom (e.g.
urgency, frequency, nighttime urination and leakage).
The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal.
The scores of the 6 questions are added and converted to a 100-point scale.
The symptom bother score ranges from 0-100.
A higher score is associated with a high degree of bother.
For this outcome measure, we report the change in the mean symptom bother scale from 6 months to baseline.
A negative change means that the degree of symptom bother decreased at 6 months compared to before treatment.
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6 months post-initial treatment
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Change in Number of Voids as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes.
The change in number of voids over a 3 day period at 6 months minus baseline will be measured.
A negative number means the number of voids went down compared to baseline.
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6 months post-initial treatment
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Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best).
Higher scores indicate higher sexual functioning.
Scores range from 2-36.
A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction.
Scores below this value indicate sexual dysfunction.
The overall change is measured at 6 months minus baseline.
A positive score means the sexual dysfunction symptoms are getting worse.
Only people that had sexual activity were included.
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6 months post-initial treatment
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Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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A clean catch urine specimen will be collected at each visit.
A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture.
A positive urine culture has the presence of bacterial growth.
Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture at or before 6 months post-initial treatment will be counted.
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6 months post-initial treatment
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Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.
There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks.
Each answer is scored on a scale from 0 = not at all to 3 = nearly every day.
All scores are added up to calculate the total score which ranges from 0 - 21.
Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended.
In this outcome measure we report the change in GAD-7 score between 6 months and baseline.
A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 6 months compared to before treatment.
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6 months post-initial treatment
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Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks.
For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g.
sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration).
Each question is scored from 0 = not at all to 3 = nearly every day.
The scores of each question are added together to form the total score, which ranges from 0 - 24.
The higher the score, the more severe depressive symptoms are.
A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms.
Here we report the change in score between 6 months and baseline.
A negative number means there is a reduction in PHQ8 score at 6 months compared to before treatment and therefore a reduction in depression.
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6 months post-initial treatment
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Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 6 Months.
Aikaikkuna: 6 months post-initial treatment
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The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems.
The I-QOL has 22 incontinent-specific quality of life items.
The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items).
Each question has a five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All.
All 22 items are summed up, and the sum is converted to a 100-point scale.
The range of the score is 0-100, with a high score indicating a better quality of life.
In this outcome measure we report the change in the I-QOL score at 6 months minus the score at baseline.
A positive score indicates that the quality of life improved at 6 months compared to before treatment.
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6 months post-initial treatment
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The Presence of Lactobacillus, Assessed by Vaginal Swab at 6 Months.
Aikaikkuna: 6 months post-initial treatment
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A vaginal exam is completed at 6 months.
In some cases the 6 month visit was completed remotely and thus a vaginal exam was not completed.
Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed.
This is the total number of patients positive for lactobacillus at 6 months.
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6 months post-initial treatment
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Change in Patient Global Impression of Improvement (PGI-I) Score at 36 Months.
Aikaikkuna: 36 months post-initial treatment
|
The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment.
The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment."
There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse".
A lower score would represent improvement and a favorable outcome.
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36 months post-initial treatment
|
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Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 36 Month Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present.
Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall.
The total VHIS score is a sum of the individual scores of these 5 vaginal parameters.
The scale ranges from 5-25.
A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal/healthy vaginal tissue.
For this outcome measure we reported the change in VHIS between 36 months and baseline.
A positive number means that vaginal tissue is healthier at 36 months compared to baseline.
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36 months post-initial treatment
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Change in Urinary Symptoms, Specifically Stress Urinary Incontinence as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-inital Treatment.
Aikaikkuna: 36 months post-initial treatment
|
The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI).
This outcome measure is focused on the SUI score only (QUID-SUI).
Patients are asked how often they leak urine in three different situations.
Responses range from 0 = none of the time, to 5 = all of the time.
The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g.
cough, lifting, exercise).
Here we report the change in QUID-SUI score from 36 months to baseline.
A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 36 months compared to baseline.
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36 months post-initial treatment
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Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI).
This outcome measure is focused on the UUI score only (QUID-UUI).
Patients are asked how often they leak urine in three different situations related to urgency.
Responses range from 0 = none of the time, to 5 = all of the time.
The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency.
Here we report the change in QUID-UUI score from 6 months to baseline.
A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 6 months compared to before treatment.
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6 months post-initial treatment
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Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
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The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI).
This outcome measure is focused on the UUI score only (QUID-UUI).
Patients are asked how often they leak urine in three different situations related to urgency.
Responses range from 0 = none of the time, to 5 = all of the time.
The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency.
Here we report the change in QUID-UUI score from 36 months to baseline.
A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 36 months compared to before treatment.
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36 months post-initial treatment
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Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
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For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.
In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions.
Each question asks how the patient's quality of life has been impacted.
The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal.
The scores of the 13 questions are added and converted to a 100-point scale.
The HR-QOL score ranges from 0-100.
A higher score is associated with a better quality of life.
For this outcome measure, we report the change in the mean HR-QOL score for 36 months minus baseline.
A positive change means that the quality of life became better by 36 months as compared to before treatment.
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36 months post-initial treatment
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Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.
In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions.
Each question asks about the level of bother related to a specific symptom (e.g.
urgency, frequency, nighttime urination and leakage).
The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal.
The scores of the 6 questions are added and converted to a 100-point scale.
The symptom bother score ranges from 0-100.
A higher score is associated with a high degree of bother.
For this outcome measure, we report the change in the mean symptom bother scale from 36 months to baseline.
A negative change means that the degree of symptom bother decreased at 36 months compared to before treatment.
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36 months post-initial treatment
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Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
|
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.
In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions.
Each question asks how the patient's quality of life has been impacted.
The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal.
The scores of the 13 questions are added and converted to a 100-point scale.
The HR-QOL score ranges from 0-100.
A higher score is associated with a better quality of life.
For this outcome measure, we report the change in the mean HR-QOL score for 6 months minus baseline.
A positive change means that the quality of life became better by 6 months as compared to before treatment.
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6 months post-initial treatment
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Change in Number of Voids as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes.
The change in number of voids over a 3 day period at 36 months minus baseline will be measured.
A negative number means the number of voids went down compared to baseline.
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36 months post-initial treatment
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Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
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A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences).
The change in number of stress urinary incontinence episodes over a 3 day period at 6 months minus baseline will be measured.
A negative number means the number of stress urinary incontinence events went down compared to baseline.
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6 months post-initial treatment
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Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences).
The change in number of stress urinary incontinence episodes over a 3 day period at 36 months minus baseline will be measured.
A negative number means the number of stress urinary incontinence events went down compared to baseline.
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36 months post-initial treatment
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Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Aikaikkuna: 6 months post-initial treatment
|
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events).
The change in number of urge urinary incontinence events over a 3 day period at 6 months minus baseline will be measured.
A negative number means the number of urge urinary incontinence events went down compared to baseline.
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6 months post-initial treatment
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Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events).
The change in number of urge urinary incontinence events over a 3 day period at 36 months minus baseline will be measured.
A negative number means the number of urge urinary incontinence events went down compared to baseline.
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36 months post-initial treatment
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Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
|
The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.
There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks.
Each answer is scored on a scale from 0 = not at all to 3 = nearly every day.
All scores are added up to calculate the total score which ranges from 0 - 21.
Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended.
In this outcome measure we report the change in GAD-7 score between 36 months and baseline.
A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 36 months compared to before treatment.
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36 months post-initial treatment
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Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
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The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks.
For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g.
sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration).
Each question is scored from 0 = not at all to 3 = nearly every day.
The scores of each question are added together to form the total score, which ranges from 0 - 24.
The higher the score, the more severe depressive symptoms are.
A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms.
Here we report the change in score between 36 months and baseline.
A negative number means there is a reduction in PHQ8 score at 36 months compared to before treatment and therefore a reduction in depression.
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36 months post-initial treatment
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Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
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The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best).
Higher scores indicate higher sexual functioning.
Scores range from 2-36.
A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction.
Scores below this value indicate sexual dysfunction.
The change is measured as the difference at 36 months minus baseline.
A positive score means the sexual dysfunction symptoms are getting worse.
Only people that had sexual activity were included.
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36 months post-initial treatment
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Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 36 Months Post-initial Treatment.
Aikaikkuna: 36 months post-initial treatment
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A clean catch urine specimen will be collected at each visit.
A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture.
A positive urine culture has the presence of bacterial growth.
Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture after 6 months but before or at 36 months post-initial treatment will be counted.
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36 months post-initial treatment
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The Presence of Lactobacillus, Assessed by Vaginal Swab at 36 Months.
Aikaikkuna: 36 months post-initial treatment
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A vaginal exam is completed at 36 months.
In some cases the 36 month visit was completed remotely and thus a vaginal exam was not completed.
Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed.
This is the total number of patients positive for lactobacillus at 36 months.
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36 months post-initial treatment
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Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 36 Months.
Aikaikkuna: 36 months post-initial treatment
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The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems.
The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All.
All 22 items are summed up, and the sum is converted to a 100-point scale.
The range of the score is 0-100, with a high score indicating a better quality of life.
In this outcome measure we report the change in the I-QOL score at 36 months minus the score at baseline.
A positive score indicates that the quality of life improved at 36 months compared to before treatment.
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36 months post-initial treatment
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Kenneth Peters, MD, Corewell Health William Beaumont University Hospital
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 8. lokakuuta 2018
Ensisijainen valmistuminen (Todellinen)
Torstai 15. joulukuuta 2022
Opintojen valmistuminen (Todellinen)
Tiistai 10. kesäkuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 3. elokuuta 2018
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 20. syyskuuta 2018
Ensimmäinen Lähetetty (Todellinen)
Maanantai 24. syyskuuta 2018
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 17. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 29. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Mielenterveyshäiriöt
- Sukuelinten sairaudet, mies
- Miesten urogenitaaliset sairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Virtsaamishäiriöt
- Alempien virtsateiden oireet
- Urologiset ilmenemismuodot
- Infektiot
- Sukuelinten sairaudet, naiset
- Virtsarakon sairaudet
- Seksuaalinen toimintahäiriö, fysiologinen
- Seksuaaliset häiriöt, psykologiset
- Emättimen sairaudet
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Virtsankarkailu
- Virtsankarkailu, stressi
- Virtsatieinfektiot
- Virtsarakko, yliaktiivinen
- Dyspareunia
- Vaginiitti
Muut tutkimustunnusnumerot
- 2018-142
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EI
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