Trial Outcomes & Findings for A Long Term Follow up of Anterior Meshes for Recurrent Prolapse (NCT NCT02642835)

NCT ID: NCT02642835

Last Updated: 2018-05-29

Results Overview

clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.

• Recruitment status: COMPLETED
• Target enrollment: 48 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2018-05-29

Participant Flow

Participant milestones

Measure	Mesh Group all had an anterior mesh for recurrent prolapse
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

Baseline characteristics by cohort

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
BMI	27.4 wt kg/ht m squared n=5 Participants
Parity	2 vaginal deliveries past 28 weeks n=5 Participants
time to follow up (months)	82 number of months n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.

Outcome measures

Measure	Mesh Group n=43 Participants underwent anterior mesh for recurrent cystocele
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted	5 Participants

SECONDARY outcome

Timeframe: 1 hour

The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.

A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.

Outcome measures

Measure	Mesh Group n=43 Participants underwent anterior mesh for recurrent cystocele
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination	26 Participants

SECONDARY outcome

Timeframe: 1 hour

Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Complaining of a Bulge. Recurrent Prolapse	14 Participants

SECONDARY outcome

Timeframe: 1 hour

clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina	1 Participants

SECONDARY outcome

Timeframe: 1 hour

This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment	8 Participants

SECONDARY outcome

Timeframe: 1 hour

The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Developed New Stress Incontinence	5 Participants

SECONDARY outcome

Timeframe: 1 hour

The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Rated Their Improvement as Better or Very Much Better	33 Participants

SECONDARY outcome

Timeframe: 1 hour

A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Needed Surgical Mesh Removal for Erosion	2 Participants

SECONDARY outcome

Timeframe: 1 hour

patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Needed Reoperations for Pain	3 Participants

SECONDARY outcome

Timeframe: 1 hour

This records any problems that were encountered at the original insertion of the mesh. clinic visit

Outcome measures

Measure	Mesh Group n=48 Participants underwent anterior mesh for recurrent cystocele
Number of Participants Who Experienced Intraoperative Complications	0 Participants

Adverse Events

Mesh Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Jonaathan Duckett -Consultant Urogynaecologist

Medway NHS Foundation Trust

Phone: 01634

Email: jraduckett@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place