Pelvic Organ ProlapseHUPPSNCT04890951
Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
An observational study of Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
Trial summary
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Hysteropexy and Hysterectomy and vaginal vault suspension
- Type of treatment
- Surgery or procedure
- How many people
- 321 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women seeking surgical correction of POP at one of the study sites.
Who may be able to join
- Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)
- Elect surgical management of POP
- Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction
- Desire no further pregnancy
- Can communicate in English
- Are ≥18 years in age
Who cannot join
- Prior hysterectomy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pelvic Floor Clinic
Calgary, Alberta
Natalie Scime, MSc, natalie.scime@ucalgary.ca
About this study
Official title: Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Hysteropexy, Hysterectomy and vaginal vault suspension
- Keywords
- Pelvic Organ Prolapse, Gynecologic Surgery, Female, Epidemiology
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteropexyProcedure or surgery
Uterine preservation through suspension
Hysterectomy and vaginal vault suspensionProcedure or surgery
Uterine removal and sewing the vagina upwards
| Study group | Role | What they receive |
|---|---|---|
| Uterine Preservation | Not described Receives: Procedure: Hysteropexy | |
| Hysterectomy | Not described Receives: Procedure: Hysterectomy and vaginal vault suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic failure to correct apical POP
Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length
Measured: 1 year
Secondary outcomes (14)
Overall failure to correct POP
POP-Q stage ≥2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery
Measured: 1 year
Subjective failure to correct POP
Patient report of bulge symptoms at 6 weeks or 1 year, using one item on the PFDI-20: "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Measured: 6 weeks; 1 year
Length of surgery (minutes)
Measured: Peri-operative
Estimated blood loss during surgery >500 mL
Measured: Peri-operative
Procedural complications
E.g., peri-operative blood transfusion, visceral injury
Measured: Peri-operative
Post-operative infection
E.g., abscess, urinary tract infection
Measured: Peri-operative
Opioid use in-hospital
Measured by Morphine milliequivalent (mEq)
Measured: Peri-operative
Resumption of spontaneous voiding (days)
Measured: Peri-operative
Length of post-operative stay (days)
Measured: Peri-operative
PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score
Change from baseline
Measured: 6 weeks; 1 year
PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score
Change from baseline
Measured: 6 weeks; 1 year
PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score
Change from baseline
Measured: 6 weeks; 1 year
Presentation at the emergency department
Measured: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Hospital readmission
Measured: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), M.S.I. Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890951
- Sponsor's protocol ID
- REB19-2134
- Acronym
- HUPPS
- Status last verified
- Apr 2021
- First submitted
- 5 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scime NV, Ramage K, Brennand EA; Calgary Women's Pelvic Health Research Group. Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study. BMJ Open. 2021 Oct 4;11(10):e053679. doi: 10.1136/bmjopen-2021-053679.
PubMed 34607873
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study
- ClinicalTrials.gov ID
- NCT04890951
- Acronym / sponsor ID
- HUPPS / REB19-2134
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, Gynecologic Surgery, Female, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), M.S.I. Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine Preservation | – | Procedure: Hysteropexy |
| Hysterectomy | – | Procedure: Hysterectomy and vaginal vault suspension |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women seeking surgical correction of POP at one of the study sites.
Key inclusion criteria (6 listed)
- Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)
- Elect surgical management of POP
- Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction
- Desire no further pregnancy
- Can communicate in English
Key exclusion criteria (1 listed)
- Prior hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteropexyUterine preservation through suspension | Procedure or surgery | Uterine Preservation |
| Hysterectomy and vaginal vault suspensionUterine removal and sewing the vagina upwards | Procedure or surgery | Hysterectomy |
Primary outcome
Anatomic failure to correct apical POP
Time frame: 1 year
Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length
14 secondary outcomes
Overall failure to correct POP
Time frame: 1 year
Subjective failure to correct POP
Time frame: 6 weeks; 1 year
Length of surgery (minutes)
Time frame: Peri-operative
Estimated blood loss during surgery >500 mL
Time frame: Peri-operative
Procedural complications
Time frame: Peri-operative
Post-operative infection
Time frame: Peri-operative
Opioid use in-hospital
Time frame: Peri-operative
Resumption of spontaneous voiding (days)
Time frame: Peri-operative
Length of post-operative stay (days)
Time frame: Peri-operative
PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score
Time frame: 6 weeks; 1 year
PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score
Time frame: 6 weeks; 1 year
PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score
Time frame: 6 weeks; 1 year
Presentation at the emergency department
Time frame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Hospital readmission
Time frame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 34607873Scime NV, Ramage K, Brennand EA; Calgary Women's Pelvic Health Research Group. Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study. BMJ Open. 2021 Oct 4;11(10):e053679. doi: 10.1136/bmjopen-2021-053679.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin A Brennand, MD (403-944-1636, Erin.brennand@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic failure to correct apical POP (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.