Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT

NCT02808377 | Unknown

• 1 other identifier: A094029
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (18)

• Change in POP-Q quantitative measurements from baseline

  6 months

• Change in POP-Q quantitative measurements from baseline

  12 months

• Change in POP-Q quantitative measurements from baseline

  24 months

• Division of vaginal band

  6months

• Anatomic success of any associated posterior repair procedure

  24 months post operative

Other Outcomes (1)

• Complications of surgery as per the Clavien-Dindo classification system

  Peri operative

Study Arms (2)

SPOP

ACTIVE COMPARATOR

This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks.

Other: Surgical Pelvic Organ Pessary

Non Intervention

NO INTERVENTION

Routine post operative care

Interventions

Surgical Pelvic Organ Pessary OTHER

In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.

SPOP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or over
• Reasonable level of English to complete questionnaires
• Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Department of Urogynaecology

Cambridge, Cambridgeshire, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynaecology Subspecialist trainee

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)