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Lasertherapie voor de behandeling van urogenitale symptomen bij vrouwen

29 juni 2026 bijgewerkt door: Kenneth M Peters, MD, Corewell Health East

Fractionele kooldioxidelasertherapie van de vagina voor de behandeling van urogenitale symptomen bij vrouwen

Dit is een prospectieve observationele studie van vrouwen die een vaginale behandeling ondergaan met de fractionele kooldioxide (fCO2) laser voor verschillende urogenitale symptomen.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Fractionele koolstofdioxide (fCO2) laserbehandeling van het vaginale weefsel is voorgesteld als een behandeling voor verschillende urogenitale symptomen, waaronder vaginale jeuk, branderigheid, droogheid, dyspareunie (moeilijke of pijnlijke geslachtsgemeenschap), dysurie (pijnlijk of moeilijk urineren), nycturie ( 's nachts wakker worden om te plassen), incontinentie (onvrijwillig urineverlies), vaak moeten plassen, aandrang tot urineren en urineweginfectie (UTI).

Casusrapporten en casusreeksgegevens suggereren dat laserbehandeling van de vaginale weefsels goed wordt verdragen door patiënten en geen ernstige risico's voor de patiënt met zich meebrengt. Verschillende casusreeksen laten verbeteringen zien in vulvovaginale en urinaire symptomen en in seksuele functie. Deze onderzoeken komen echter uit een select aantal centra, zijn klein en zijn ook bevooroordeeld doordat de laserbehandeling alleen beschikbaar is voor patiënten die ervoor kunnen betalen. Bovendien rapporteren de meeste onderzoeken alleen over vulvovaginale symptomen, ondanks het toenemende gebruik van laser voor urinaire symptomen. Verschillende recente hoofdartikelen hebben opgeroepen tot grotere studies met langere follow-up en hoogwaardige uitkomstmaten. Deze studie is ontworpen om aan deze behoeften te voldoen.

Dit is een prospectieve observationele studie van vrouwen die een vaginale behandeling met de fCO2-laser ondergaan voor een breed scala aan patiënten met vulvovaginale, seksuele en/of urologische klachten. De effecten van fCO2-therapie zullen worden geëvalueerd door middel van verschillende fysieke beoordelingen en vragenlijsten voor patiënten.

Studietype

Observationeel

Inschrijving (Werkelijk)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Royal Oak, Michigan, Verenigde Staten, 48073
        • Corewell Health William Beaumont University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Vrouwen die aan alle inclusiecriteria en niet aan de exclusiecriteria voldoen, kunnen in het onderzoek worden opgenomen.

Beschrijving

Inclusiecriteria:

  1. Vrouw
  2. 18 jaar of ouder en 90 jaar of jonger

  3. Een of meer van de volgende indicaties voor fCO2 laserbehandeling:

    1. Genito-urinaire symptomen van de menopauze, inclusief na natuurlijke, medisch geïnduceerde of chirurgische menopauze
    2. Vaginale droogheid, branderigheid, jeuk of dyspareunie niet gerelateerd aan de menopauze
    3. Stress-urine-incontinentie
    4. Terugkerende urineweginfecties (UTI's), gedefinieerd als 4 of meer per jaar
    5. Overactieve blaas
  4. Moet de geïnformeerde toestemming ondertekenen
  5. Moet bereid zijn zich te houden aan het onderzoeksprotocol

Uitsluitingscriteria:

  1. Contra-indicaties voor fCO2-laserbehandeling, zoals:

    1. Momenteel geïmplanteerde synthetische bekkengaas, sling of tape
    2. Huidige of eerdere genitale kankers
    3. Straling naar het vaginale of colo-rectale weefsel
    4. Momenteel zwanger of minder dan 3 maanden na de zwangerschap
    5. Niet-gediagnosticeerde vaginale of cervicale laesies
  2. Patiënten die in de afgelopen 12 maanden een vaginale fCO2-laserbehandeling hebben ondergaan
  3. Patiënten die in de afgelopen 3 maanden zijn behandeld met vaginaal oestrogeen
  4. Patiënten met niet-gediagnosticeerde vaginale bloedingen
  5. Actieve vulvaire of vaginale infectie, waaronder herpes, candidiasis, enz.
  6. Huidige urineweginfectie (UTI), bevestigd door positieve urinekweek en door de patiënt gemelde symptomen
  7. Bekken- of vaginale operatie in de afgelopen 9 maanden
  8. Verzakking van het bekkenorgaan voorbij de introïtus
  9. Patiënt heeft andere kenmerken die, volgens het oordeel van de onderzoeker, hem ongeschikt achten (d.w.z. kan het risico van de patiënt verhogen, kan de uitvoering van het onderzoek beïnvloeden enz.) voor de behandeling en/of het onderzoek
  10. Deelname aan een onderzoeksstudie waarbij een onderzoeksbehandeling, medicatie en/of biologische stof werd gebruikt binnen 6 maanden of minder voorafgaand aan de datum van het screeningsbezoek

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
fCO2 Laser Therapie Groep
Vrouwen behandeld met de fCO2 laser
Apparaat: fCO2 Laser Therapie Groep
Vrouwen die deelnemen aan het onderzoek zullen drie behandelingen ondergaan met de fractionele kooldioxide (fCO2) laser. Het interval tussen de behandelingen is ongeveer zes weken. Intravaginale laserbehandelingen worden uitgevoerd op 8 punten op elk niveau van de vaginawand.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patiënt Global Impression of Improvement (PGI-I) Score na 4 weken na de initiële behandeling
Tijdsspanne: 4 weken na de initiële behandeling
De PGI-I-score wordt 4 weken na voltooiing van de initiële behandeling geregistreerd. De PGI-I vraagt ​​de patiënt om "het vakje aan te vinken dat het beste beschrijft hoe uw urinaire en/of vaginale symptomen nu zijn, vergeleken met hoe uw symptomen waren voordat u met dit onderzoek begon." Er zijn 7 mogelijke antwoorden, variërend van 1 tot 7, waarbij 1 'heel veel beter' is, 2 'veel beter' is, 3 'een beetje beter' is, 4 'geen verandering' is, 5 'een beetje slechter' is. 6 is "veel erger", en 7 is "heel veel erger". Een score van 1 tot 3 duidt op verbetering.
4 weken na de initiële behandeling

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

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Sponsor

Corewell Health East

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 oktober 2018

Primaire voltooiing (Werkelijk)

15 december 2022

Studie voltooiing (Werkelijk)

10 juni 2025

Studieregistratiedata

Eerst ingediend

3 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2018

Eerst geplaatst (Werkelijk)

24 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2018-142

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

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