Pelvic Organ Prolapse Clinical Trial
— NTRSPOPOfficial title:
VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre. - Currently on the hospital waiting list for vaginal native tissue repair - Willingness to participate - Medically fit for surgery - 18 years or over - Reasonable level of English to complete questionnaires - Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach Exclusion Criteria: - Asymptomatic pelvic organ prolapse - Refusal to participate - Medically unfit for surgery - Under 18 - Unable to complete questionnaires due to poor level of english - Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Urogynaecology | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complications of surgery as per the Clavien-Dindo classification system | Peri operative | No | |
Primary | Success in anterior compartment. | Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire. |
6 months post operative | No |
Primary | Success in Anterior Compartment | Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire. |
12 months post operative | No |
Primary | Success in Anterior Compartment | Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire. |
24months post operative | No |
Secondary | Change in POP-Q quantitative measurements from baseline | 6 months | No | |
Secondary | Change in POP-Q quantitative measurements from baseline | 12 months | No | |
Secondary | Change in POP-Q quantitative measurements from baseline | 24 months | No | |
Secondary | Division of vaginal band | Any patient requiring repeat procedure for division vaginal band with in 6 months post operative. | 6months | No |
Secondary | Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 24 months post operative | No |
Secondary | Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 6 months | No |
Secondary | Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 12 months | No |
Secondary | Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 6 months | No |
Secondary | Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 12 months | No |
Secondary | Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 24 months | No |
Secondary | Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery | 6 months | No | |
Secondary | Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery | 12 months | No | |
Secondary | Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery | 24months | No | |
Secondary | Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 6 months | No |
Secondary | Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 12 months | No |
Secondary | Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 24 months | No |
Secondary | Change in PFDI - 20 | Validated patient reported outcome (pelvic floor distress inventory) - | 24 months | No |
Secondary | Change in PFDI-20 | Validated patient reported outcome (pelvic floor distress inventory) - | 12 months | No |
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