Trial · NCT07030426
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment Rate | 12 months | For the primary feasibility outcome, the trial will be considered feasible if at least 75% of the target sample can be recruited in 12 months. |
| Secondary | Loss to Follow Up Rate - 6 months | 6 Months post surgery | Loss to follow up rates at each of the study end points measured as n/N (%). |
| Secondary | Loss to Follow Up Rate - 1 year | 1 year post surgery | Loss to follow up rates at each of the study end points measured as n/N (%). |
| Secondary | Loss to Follow Up Rate - 2 years | 2 years post surgery | Loss to follow up rates at each of the study end points measured as n/N (%). |
| Secondary | Patient Satisfaction - 6 weeks | 6 weeks post surgery | Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied). |
| Secondary | Patient Satisfaction - 6 months | 6 months post surgery | Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied). |
| Secondary | GSM Symptoms - 6 weeks | 6 weeks post surgery | GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms. |
| Secondary | GSM Symptoms - 6 months | 6 weeks post surgery | GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms. |
| Secondary | GSM Symptoms - 1 year | 1 year post surgery | GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms. |
| Secondary | GSM Symptoms - 2 years | 2 years post surgery | GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms. |
| Secondary | Prolapse Quality of Life - 6 weeks | 6 weeks post surgery | The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. |
| Secondary | Prolapse Quality of Life - 6 months | 6 months post surgery | The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. |
| Secondary | Prolapse Quality of Life - 1 year | 1 year post surgery | The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. |
| Secondary | Prolapse Quality of Life - 2 years | 2 years post surgery | The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. |
| Secondary | Complications - 6 weeks | 6 weeks post surgery | A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure. |
| Secondary | Complications - 6 months | 6 months post surgery | A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure. |
| Secondary | Treatment Failure - 1 year | 1 year post surgery | A composite measure of the incidence of mesh erosion and treatment failure. |
| Secondary | Treatment Failure - 2 years | 2 years post surgery | A composite measure of the incidence of mesh erosion and treatment failure. |
| Other | Adherence | 6 weeks post surgery | Adherence rates during the 6-week intervention period based on groups assignment. |
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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