Trial · NCT07887464
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of urinary incontinence (ICIQ-UI SF score) | Baseline (V0) through 12 months (V0, V1 at 3 months, V2 at 6 months, V3 at 12 months) | Total score on the ICIQ-UI SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form), range 0-21, with higher scores indicating greater severity. Treatment response will be defined as an improvement ≥2.52 points (MCID). |
| Secondary | Overactive bladder symptoms (ICIQ-OAB) | V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months) | Score on the ICIQ-OAB questionnaire (8 items), range 0-16; higher scores indicate greater impairment. |
| Secondary | Incontinence severity - Sandvik Index (ISI) | V0(Day 1) and V2 (6 months) | Score on the Incontinence Severity Index (2 items), range 0-12, classified as mild/moderate/severe/very severe. |
| Secondary | Lower urinary tract symptom-specific quality of life (ICIQ-LUTSqol) | V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months) | Score on the ICIQ-LUTSqol questionnaire (19 items), range 19-76; higher scores indicate greater impairment in quality of life. |
| Secondary | Patient Global Impression of Severity (PGI-S) | V0 (baseline) | Single-item scale (1-4) assessing the patient's global perception of symptom severity. |
| Secondary | Patient Global Impression of Improvement (PGI-I) | V1 (3 months), V2 (6 months), V3 (12 months) | Single-item scale (1-7) assessing the patient's global perception of improvement relative to baseline. |
| Secondary | Sexual function (FSFI) | V0(Day 1), V1 (3 months), V2 (6 months), V3 (12 months) | Female Sexual Function Index (19 items, 6 domains), range 2-36; a cutoff score ≤26.55 indicates female sexual dysfunction. |
| Secondary | Pelvic floor muscle function (Oxford Scale ) | V0(Day 1) and V2 (6 months) | Pelvic floor muscle contraction strength will be assessed by vaginal palpation using the Oxford Scale, ranging from 0 (no contraction) to 5 (strong contraction). The outcome will be reported as the Oxford Scale score. |
| Secondary | Amount of urine loss (1-hour Pad Test, ICS) | V0(Day 1) and V2 (6 months) | Standardized 1-hour pad test; objective quantification of urine loss in grams. |
| Secondary | Voiding pattern (3-day Bladder Diary) | V0(Day 1) and V2 (6 months) | Voiding pattern and urinary symptoms will be assessed using a 3-day bladder diary. The recorded variables will include daytime and nighttime voiding frequency, urinary incontinence episodes per 24 hours, urgency episodes, voided urine volume, fluid intake, and pad use. Results will be reported for each recorded variable using the corresponding measurement unit. |
| Secondary | Treatment satisfaction | V1(3 months), V2(6 months), V3 (12 months) | Proportion of patients reporting satisfaction or high satisfaction with the treatment received, assessed via a satisfaction survey. |
| Secondary | Contextual physical activity variables (wearables) | Continuous throughout the follow-up period (minimum 7 days) | physycal activity via a wearable device with local storage. |
| Secondary | Contextual sleep variables (wearables) | Continuous throughout the follow-up period (minimum 7 days) | sleep duration via a wearable device with local storage. |
| Secondary | Contextual daily heart rate (wearables) | Continuous throughout the follow-up period (minimum 7 days) | mean daily heart ratevia a wearable device with local storage. |
| Secondary | Pelvic floor muscle function (PERFECT protocol) | Baseline (Day 1) and 6 months | Pelvic floor muscle function will be assessed using the PERFECT protocol, including power, endurance, number of repetitions, number of fast contractions, co-contraction, and timing. Each component will be recorded according to the standardized PERFECT protocol. |
| Secondary | Bladder symptoms assessed by the ICIQ-Bladder Diary (ICIQ-BD) | Baseline (Day 1) and 6 months | Bladder symptoms will be assessed using the International Consultation on Incontinence Questionnaire-Bladder Diary (ICIQ-BD). The outcome will be reported according to the scoring and variables specified by the ICIQ-BD instrument. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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