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Trial · NCT04420533

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange from baseline in OABSS at Week 12Baseline and Week 12Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
PrimaryChange from baseline in IIEF-5 at Week 12Baseline and Week 12Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)
SecondaryChange from baseline in OABSS at Week 4Baseline and Week 4Change from baseline in OABSS (Overactive Bladder Symptom Score) at Week 12 (lower OABSS score represent a better outcome)
SecondaryChange from baseline in IIEF-5 at Week 4Baseline and Week 4Change from baseline in IIEF-5 (International Index of Erectile Function) at Week 12 (higher IIEF-5 score represent a better outcome)
SecondaryChange from baseline in MSHQ-EjD Short Form score at Week 4Baseline and Week 4
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 4 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lowerer MSHQ-EjD Short Form Q4 score represent a better outcome)
SecondaryChange from baseline in MSHQ-EjD Short Form score at Week 12Baseline and Week 12
Change from baseline in MSHQ-EjD (Male Sexual Health Questionnaire -Ejaculatory Domain) Short Form score at Week 12 (higher MSHQ-EjD Short Form Q1-Q3 sum scores represent a better outcome; lower MSHQ-EjD Short Form Q4 score represent a better outcome)
SecondaryNet change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12
Net change of Frequency episode, nocturia episode, urgency episode, UUI episodes in 3-day voiding diary from baseline to 1 and 3 months after the treatment day (lower episode represent a better outcome)
SecondaryNet change of Qmax from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12Net change of maximum flow rate (Qmax) from baseline to 1 and 3 months after the treatment day (higher Qmax and voided volume represent a better outcome)
SecondaryNet change of voided volume from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12Net change of voided volume from baseline to 1 and 3 months after the treatment day (higher voided volume represent a better outcome)
SecondaryNet change of PVR volume from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12Net change of postvoid residual (PVR) volume from baseline to 1 and 3 months after the treatment day (lower PVR represent a better outcome)
SecondaryNet change of IPSS from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12Net change of IPSS (International prostate symptom score) from baseline to 1 and 3 months after the treatment day (lower IPSS represent a better outcome)
SecondaryNet change of PPBC score from baseline to 1 and 3 months after the treatment dayBaseline, Week 4 and Week 12Net change of PPBC score (Patient perception of bladder condition) from baseline to 1 and 3 months after the treatment day (lower PPBC represent a better outcome)
SecondaryNet changes of the GRABaseline, Week 4 and Week 12
Global response assessment (GRA) of satisfaction by the patient (categorized into -3, -2, -1, 0, 1, 2, 3, indicating markedly worse to markedly improved) at 1 and 3 months after the treatment day. An improvement of GRA by 2 scales is considered effective.

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.

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