A pilot study assessing the efficacy of the Capio device for sacrospinous ligament fixation.

Phase 4

• Conditions: Apical vaginal prolapse; Surgery - Surgical techniques; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12612001273875
• Lead Sponsor: Boston Scientific

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Women consented to undergo a sacrospinous ligament fixation

Exclusion Criteria

Unfit for surgery
Unable to fill in online questionnaires
Women preferring or electing to undergo abdominal or uterosacral vault suspension
Women undergoing mesh surgery
Women undergoing uterine preservation surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective success of surgery at 12 months with success defined as point C = halfway of total vaginal length.<br>(The POP-Q exam (particularly point C) will be undertaken intra-operatively (pre and post fixation) at 6 weeks post operatively and at 12 months post operatively)<br>[Intraoperatively (pre- and post- fixation)<br>6 weeks postoperatively<br>12 months postoperatively]

Secondary Outcome Measures

Name	Time	Method
1.Objective success of surgery at 6 weeks post-operatively will be assessed clinically using the POP-Q examination[6 weeks];Subjective success of the surgery at 6 weeks and 12 months postoperatively<br>(ePAQ questionnaire (ePAQ Systems Ltd) will be completed by participants pre operatively, at 6 weeks post operatively and at 12 months post operatively)<br>[6 weeks postoperatively<br>12 months postoperatively];operative time ( from when dissection to SSL commences until the time of fixation to the vaginal vault, therefore not including VH and/or repair times)[immediately post operation];estimated blood loss- this is an assessment made by the surgeon postoperatively- will include the amount of blood in the suction device as well as blood on sponges [immediately post operation];post operative right buttock pain- this will be assessed by a simple pain diary which each participant is required to fill out for 6 weeks postoepratively[6 weeks]