Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Laseroterapia w leczeniu objawów układu moczowo-płciowego u kobiet

29 czerwca 2026 zaktualizowane przez: Kenneth M Peters, MD, Corewell Health East

Frakcyjna laserowa terapia dwutlenkiem węgla pochwy w leczeniu objawów układu moczowo-płciowego u kobiet

Jest to prospektywne badanie obserwacyjne kobiet poddawanych leczeniu dopochwowemu laserem frakcyjnego dwutlenku węgla (fCO2) z powodu różnych objawów układu moczowo-płciowego.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Laserowe leczenie tkanek pochwy frakcyjnym dwutlenkiem węgla (fCO2) zostało zaproponowane jako leczenie różnych objawów układu moczowo-płciowego, w tym świądu pochwy, pieczenia, suchości, dyspareunii (trudne lub bolesne stosunki płciowe), dyzurii (bolesne lub utrudnione oddawanie moczu), oddawania moczu w nocy ( budzenie się w nocy w celu oddania moczu), nietrzymanie moczu (mimowolna utrata moczu), częstomocz, parcie na mocz i zakażenie dróg moczowych (ZUM).

Opis przypadku i dane serii przypadków sugerują, że laserowe leczenie tkanek pochwy jest dobrze tolerowane przez pacjentki i nie stanowi dla pacjentki poważnego zagrożenia. W kilku seriach przypadków wykazano poprawę objawów sromowo-pochwowych i moczowych oraz funkcji seksualnych. Jednak badania te pochodzą z kilku wybranych ośrodków, są małe i są również stronnicze, ponieważ leczenie laserowe jest dostępne tylko dla pacjentów, którzy są w stanie za to zapłacić. Ponadto większość badań dotyczy jedynie objawów sromowo-pochwowych, pomimo coraz częstszego stosowania lasera w leczeniu objawów ze strony układu moczowego. W kilku niedawnych artykułach redakcyjnych wezwano do większych badań z dłuższą obserwacją i wysokiej jakości miarami wyników. Niniejsze badanie zostało zaprojektowane w celu zaspokojenia tych potrzeb.

Jest to prospektywne badanie obserwacyjne kobiet poddawanych leczeniu dopochwowemu laserem fCO2 dla szerokiego grona pacjentek z dolegliwościami sromowo-pochwowymi, seksualnymi i/lub urologicznymi. Efekty terapii fCO2 zostaną ocenione za pomocą różnych ocen fizycznych i kwestionariuszy pacjentów.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Michigan
      • Royal Oak, Michigan, Stany Zjednoczone, 48073
        • Corewell Health William Beaumont University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Kobiety spełniające wszystkie kryteria włączenia i niewykluczające mogą zostać włączone do badania.

Opis

Kryteria przyjęcia:

  1. Płeć żeńska
  2. 18 lat lub więcej i 90 lat lub mniej

  3. Jedno lub więcej z następujących wskazań do leczenia laserem fCO2:

    1. Objawy menopauzy ze strony układu moczowo-płciowego, w tym po menopauzie naturalnej, medycznej lub chirurgicznej
    2. Suchość pochwy, pieczenie, swędzenie lub dyspareunia niezwiązane z menopauzą
    3. Wysiłkowe nietrzymanie moczu
    4. Nawracające infekcje dróg moczowych (ZUM), definiowane jako 4 lub więcej w ciągu roku
    5. Nadreaktywny pęcherz
  4. Musi podpisać świadomą zgodę
  5. Musi być gotowy do przestrzegania protokołu badania

Kryteria wyłączenia:

  1. Przeciwwskazania do zabiegu laserem fCO2, takie jak:

    1. Obecnie wszczepiona syntetyczna siatka miednicy, zawiesie lub taśma
    2. Obecny lub przebyty rak narządów płciowych
    3. Promieniowanie do pochwy lub tkanki jelita grubego
    4. Obecnie w ciąży lub mniej niż 3 miesiące po ciąży
    5. Niezdiagnozowane zmiany pochwy lub szyjki macicy
  2. Pacjentki, które w ciągu ostatnich 12 miesięcy otrzymały dopochwowe leczenie laserem fCO2
  3. Pacjentki leczone estrogenami dopochwowymi w ciągu ostatnich 3 miesięcy
  4. Pacjentki z niezdiagnozowanym krwawieniem z pochwy
  5. Aktywna infekcja sromu lub pochwy, w tym opryszczka, kandydoza itp.
  6. Obecna infekcja dróg moczowych (ZUM), potwierdzona dodatnim posiewem moczu i objawami zgłaszanymi przez pacjentów
  7. Operacja miednicy lub pochwy w ciągu ostatnich 9 miesięcy
  8. Wypadanie narządu miednicy poza introitus
  9. Pacjent posiada jakiekolwiek inne cechy, które według oceny badacza uznają za nieodpowiednie (tj. mogą zwiększać ryzyko pacjenta, mogą wpływać na przebieg badania itp.) do leczenia i/lub badania
  10. Udział w badaniu eksperymentalnym, w którym zastosowano badany lek, lek i/lub lek biologiczny w ciągu 6 miesięcy lub mniej przed datą wizyty przesiewowej

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Grupa terapii laserowej fCO2
Kobiety leczone laserem fCO2
Urządzenie: Grupa terapii laserowej fCO2
Kobiety biorące udział w badaniu otrzymają trzy zabiegi laserem frakcyjnym na dwutlenku węgla (fCO2). Odstęp między zabiegami wynosi około sześciu tygodni. Dopochwowe zabiegi laserowe będą wykonywane w 8 punktach na każdym poziomie ściany pochwy.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Wynik ogólnego wrażenia poprawy pacjenta (PGI-I) po 4 tygodniach od leczenia wstępnego
Ramy czasowe: 4 tygodnie po pierwszym leczeniu
Wynik PGI-I rejestruje się 4 tygodnie po zakończeniu wstępnego leczenia. PGI-I prosi pacjenta o „zaznaczenie pola, które najlepiej opisuje obecne objawy ze strony układu moczowego i/lub pochwy w porównaniu z objawami przed rozpoczęciem tego badania”. Istnieje 7 możliwych odpowiedzi od 1 do 7, gdzie 1 oznacza „bardzo dużo lepiej”, 2 „znacznie lepiej”, 3 „trochę lepiej”, 4 „bez zmian”, 5 „trochę gorzej”, 6 to „znacznie gorzej”, a 7 to „bardzo dużo gorzej”. Wynik od 1 do 3 oznacza poprawę.
4 tygodnie po pierwszym leczeniu

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment
Ramy czasowe: 6 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.
6 months post-initial treatment
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.
Ramy czasowe: 6 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 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.
6 months post-initial treatment
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.
Ramy czasowe: 6 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 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.
6 months post-initial treatment
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.
Ramy czasowe: 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.
6 months post-initial treatment
Change in Number of Voids as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Ramy czasowe: 6 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 6 months minus baseline will be measured. A negative number means the number of voids went down compared to baseline.
6 months post-initial treatment
Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 6 Months Post-initial Treatment.
Ramy czasowe: 6 months post-initial treatment
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.
6 months post-initial treatment
Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 6 Months Post-initial Treatment.
Ramy czasowe: 6 months post-initial treatment
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.
6 months post-initial treatment
Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 6 Months Post-initial Treatment.
Ramy czasowe: 6 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 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.
6 months post-initial treatment
Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 6 Months Post-initial Treatment.
Ramy czasowe: 6 months post-initial treatment
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.
6 months post-initial treatment
Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 6 Months.
Ramy czasowe: 6 months post-initial treatment
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.
6 months post-initial treatment
The Presence of Lactobacillus, Assessed by Vaginal Swab at 6 Months.
Ramy czasowe: 6 months post-initial treatment
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.
6 months post-initial treatment
Change in Patient Global Impression of Improvement (PGI-I) Score at 36 Months.
Ramy czasowe: 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.
36 months post-initial treatment
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.
Ramy czasowe: 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.
36 months post-initial treatment
Change in Urinary Symptoms, Specifically Stress Urinary Incontinence as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-inital Treatment.
Ramy czasowe: 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.
36 months post-initial treatment
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.
Ramy czasowe: 6 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 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.
6 months post-initial treatment
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.
Ramy czasowe: 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 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.
36 months post-initial treatment
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.
Ramy czasowe: 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 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.
36 months post-initial treatment
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.
Ramy czasowe: 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.
36 months post-initial treatment
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.
Ramy czasowe: 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.
6 months post-initial treatment
Change in Number of Voids as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Ramy czasowe: 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.
36 months post-initial treatment
Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Ramy czasowe: 6 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 6 months minus baseline will be measured. A negative number means the number of stress urinary incontinence events went down compared to baseline.
6 months post-initial treatment
Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Ramy czasowe: 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.
36 months post-initial treatment
Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Ramy czasowe: 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.
6 months post-initial treatment
Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Ramy czasowe: 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.
36 months post-initial treatment
Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 36 Months Post-initial Treatment.
Ramy czasowe: 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.
36 months post-initial treatment
Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 36 Months Post-initial Treatment.
Ramy czasowe: 36 months post-initial treatment
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.
36 months post-initial treatment
Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 36 Months Post-initial Treatment.
Ramy czasowe: 36 months post-initial treatment
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.
36 months post-initial treatment
Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 36 Months Post-initial Treatment.
Ramy czasowe: 36 months post-initial treatment
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.
36 months post-initial treatment
The Presence of Lactobacillus, Assessed by Vaginal Swab at 36 Months.
Ramy czasowe: 36 months post-initial treatment
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.
36 months post-initial treatment
Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 36 Months.
Ramy czasowe: 36 months post-initial treatment
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.
36 months post-initial treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Corewell Health East

Śledczy

  • Główny śledczy: Kenneth Peters, MD, Corewell Health William Beaumont University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 października 2018

Zakończenie podstawowe (Rzeczywisty)

15 grudnia 2022

Ukończenie studiów (Rzeczywisty)

10 czerwca 2025

Daty rejestracji na studia

Pierwszy przesłany

3 sierpnia 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 września 2018

Pierwszy wysłany (Rzeczywisty)

24 września 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2018-142

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj