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Terapia laser per il trattamento dei sintomi urogenitali nelle donne

29 giugno 2026 aggiornato da: Kenneth M Peters, MD, Corewell Health East

Terapia laser ad anidride carbonica frazionata della vagina per il trattamento dei sintomi urogenitali nelle donne

Questo è uno studio osservazionale prospettico di donne sottoposte a trattamento vaginale con il laser ad anidride carbonica frazionata (fCO2) per vari sintomi urogenitali.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Il trattamento laser ad anidride carbonica frazionata (fCO2) del tessuto vaginale è stato proposto come trattamento per vari sintomi genito-urinari, tra cui prurito vaginale, bruciore, secchezza, dispareunia (rapporti sessuali difficili o dolorosi), disuria (minzione dolorosa o difficile), nicturia ( svegliarsi di notte per urinare), incontinenza (la perdita involontaria di urina), frequenza urinaria, urgenza urinaria e infezione del tratto urinario (UTI).

I dati dei case report e delle serie di casi suggeriscono che il trattamento laser dei tessuti vaginali è ben tollerato dalle pazienti e non comporta seri rischi per la paziente. Diverse serie di casi dimostrano miglioramenti nei sintomi vulvovaginali e urinari e nella funzione sessuale. Tuttavia, questi studi provengono da pochi centri selezionati, sono piccoli e sono anche prevenuti in quanto il trattamento laser è disponibile solo per i pazienti che sono in grado di pagarlo. Inoltre, la maggior parte degli studi riporta solo i sintomi vulvovaginali, nonostante l'aumento dell'uso del laser per i sintomi urinari. Diversi editoriali recenti hanno richiesto studi più ampi con un follow-up più lungo e misurazioni dei risultati di alta qualità. Questo studio è stato progettato per rispondere a queste esigenze.

Si tratta di uno studio osservazionale prospettico su donne sottoposte a trattamento vaginale con il laser fCO2 per un'ampia gamma di pazienti con disturbi vulvovaginali, sessuali e/o urologici. Gli effetti della terapia con fCO2 saranno valutati mediante varie valutazioni fisiche e questionari per i pazienti.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Michigan
      • Royal Oak, Michigan, Stati Uniti, 48073
        • Corewell Health William Beaumont University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Le donne che soddisfano tutti i criteri di inclusione e non i criteri di esclusione possono essere arruolate nello studio.

Descrizione

Criterio di inclusione:

  1. Femmina
  2. 18 anni o più e 90 anni o meno

  3. Una o più delle seguenti indicazioni per il trattamento laser fCO2:

    1. Sintomi genito-urinari della menopausa, inclusa la menopausa naturale, medica o chirurgica
    2. Secchezza vaginale, bruciore, prurito o dispareunia non correlati alla menopausa
    3. Incontinenza urinaria da sforzo
    4. Infezioni ricorrenti del tratto urinario (UTI), definite come 4 o più in un anno
    5. Vescica iperattiva
  4. Deve firmare il consenso informato
  5. Deve essere disposto a rispettare il protocollo di studio

Criteri di esclusione:

  1. Controindicazioni al trattamento laser fCO2, come:

    1. Rete pelvica sintetica attualmente impiantata, fionda o nastro
    2. Tumori genitali attuali o pregressi
    3. Radiazioni al tessuto vaginale o colon-rettale
    4. Attualmente incinta o meno di 3 mesi dopo la gravidanza
    5. Lesioni vaginali o cervicali non diagnosticate
  2. Pazienti che hanno ricevuto un trattamento laser fCO2 vaginale negli ultimi 12 mesi
  3. Pazienti trattati con estrogeni vaginali negli ultimi 3 mesi
  4. Pazienti con sanguinamento vaginale non diagnosticato
  5. Infezione vulvare o vaginale attiva, inclusi herpes, candidosi, ecc.
  6. Infezione del tratto urinario (UTI) in atto, confermata da urinocoltura positiva e sintomi riferiti dal paziente
  7. Chirurgia pelvica o vaginale negli ultimi 9 mesi
  8. Prolasso degli organi pelvici oltre l'introito
  9. Il paziente possiede altre caratteristiche che, secondo il giudizio dello sperimentatore, le ritiene inadatte (ad es. possono aumentare il rischio del paziente, possono influenzare la conduzione dello studio ecc.) per il trattamento e/o lo studio
  10. Partecipazione a uno studio sperimentale che ha utilizzato un trattamento in studio, un farmaco e/o un farmaco biologico entro 6 mesi o meno prima della data della visita di screening

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Gruppo di Laserterapia fCO2
Donne trattate con il laser fCO2
Dispositivo: Gruppo di Laserterapia fCO2
Le donne arruolate nello studio riceveranno tre trattamenti con il laser ad anidride carbonica frazionata (fCO2). L'intervallo tra i trattamenti è di circa sei settimane. I trattamenti laser intravaginali verranno erogati in 8 punti a ciascun livello della parete vaginale.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Punteggio Global Impression of Improvement (PGI-I) del paziente a 4 settimane dopo il trattamento iniziale
Lasso di tempo: 4 settimane dopo il trattamento iniziale
Il punteggio PGI-I viene registrato 4 settimane dopo il completamento del trattamento iniziale. Il PGI-I chiede al paziente di "selezionare la casella che meglio descrive come sono i suoi sintomi urinari e/o vaginali adesso, rispetto a come erano prima di iniziare questo studio". Ci sono 7 possibili risposte che vanno da 1 a 7, dove 1 è "Molto meglio", 2 è "Molto meglio, 3 è "Un po' meglio", 4 è "Nessun cambiamento", 5 è "Un po' peggio", 6 è "Molto peggio" e 7 è "Molto peggio". Un punteggio da 1 a 3 indicherebbe un miglioramento.
4 settimane dopo il trattamento iniziale

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Corewell Health East

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 ottobre 2018

Completamento primario (Effettivo)

15 dicembre 2022

Completamento dello studio (Effettivo)

10 giugno 2025

Date di iscrizione allo studio

Primo inviato

3 agosto 2018

Primo inviato che soddisfa i criteri di controllo qualità

20 settembre 2018

Primo Inserito (Effettivo)

24 settembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2018-142

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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