SSLS Procedure for Pelvic Organ Prolapse

St. Paul's Hospital, Vancouver, Canada
Pelvic Organ ProlapseBSSVF-M Procedure - Procedure
Eligibility
18+
Female

Study Summary

This trial is to compare two different types of vaginal surgery for correcting pelvic organ prolapse in women. One type uses mesh and the other doesn't, and they want to see which is better.

Eligible Conditions
  • Pelvic Organ Prolapse

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Permacol biologic mesh
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Assess overall complications at 30 days postoperatively

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 2 years postoperatively

2 years postoperatively
Composite outcome of 3 objective signs and 1 subjective symptom of POP (yes/no answers). The definition of surgical success, used in the OPTIMAL trial as described in the description below.
Month 24
Health economic evaluation
Month 24
Change in questionnaire scores between the 2 groups from baseline to 12 and 24 months: Pelvic organ prolapse/ Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Month 24
Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: Pelvic Floor Impact Questionnaire (PFIQ-7)
Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: the a validated gender-specific body image scale specifically for POP (BIPOP) Questionnaire
Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: the short form McGill pain questionnaire
Month 24
Difference between global impression of improvement (Likert Scale) of the 2 groups at 6 weeks, 12 and 24 months postoperatively
Month 24
Difference in health utilities measured in direct healthcare utilization and costs collected by the healthcare service utilization questionnaire at baseline, 6 weeks, 6, 12 and 24 months postoperatively.
Difference in health utilities measured via the EuroQol instrument (EQ-5D)and in direct healthcare utilization and costs collected by the healthcare service utilization questionnaire at baseline, 6 weeks, 6, 12 and 24 months postoperatively.
Month 24
Change in maximal POP of vaginal compartments via POPQ, obtained by research personnel (nurse or clinical fellow) trained in POPQ and blinded to group allocation. POP will be quantified and compared to baseline.
Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: Pelvic Floor Distress Inventory (PFDI-20)
Time of surgery
Difference between the 2 groups in complications eg pain or mesh exposure, reoperations, other unexpected adverse events (categorized using Clavien Dindo classification system for surgical complications).
Difference between the 2 groups in length of surgery stay (categorized using Clavien Dindo classification system for surgical complications).
Difference between the 2 groups in postoperative hospital stay (categorized using Clavien Dindo classification system for surgical complications).

Trial Safety

Phase-Based Safety

1 of 3

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1
Vaginal hysterectomy
2
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3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

SSLS Procedure
1 of 2
BSSVF-M Procedure
1 of 2

Active Control

358 Total Participants · 2 Treatment Groups

Primary Treatment: SSLS Procedure · No Placebo Group · N/A

SSLS Procedure
Procedure
ActiveComparator Group · 1 Intervention: BSSVF-M Procedure · Intervention Types: Procedure
BSSVF-M Procedure
Procedure
ActiveComparator Group · 1 Intervention: SSLS Procedure · Intervention Types: Procedure

Trial Logistics

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years postoperatively

Who is running the clinical trial?

University of AlbertaOTHER
842 Previous Clinical Trials
386,732 Total Patients Enrolled
Centre for Health Evaluation and Outcome SciencesUNKNOWN
1 Previous Clinical Trials
576 Total Patients Enrolled
McGill UniversityOTHER
369 Previous Clinical Trials
978,398 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,354 Previous Clinical Trials
1,564,503 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
100 Patients Enrolled for Pelvic Organ Prolapse
McMaster UniversityOTHER
835 Previous Clinical Trials
2,632,462 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition called pelvic organ prolapse that is causing discomfort and affects the top of your vagina.
References

Frequently Asked Questions

Is enrollment for this clinical research study still open to participants?

"According to the clinicaltrials.gov listing, this clinical study is actively seeking participants; it was initially posted on November 1st 2016 and last revised on May 17th 2022." - Anonymous Online Contributor

Unverified Answer

How many participants is the upper limit to join this research experiment?

"Affirmative. Clinicaltrials.gov's records suggest that this experiment is still recruiting patients, having been first posted on November 1st 2016 and most recently revised on May 17th 2022. A total of 358 participants are required from a single site for the trial to be completed successfully." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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