Pelvic Organ ProlapseNCT02888093
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
A study testing Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) in people with Pelvic Organ Prolapse and Cystocele, run by Joseph Kowalski at 1 site in United States.
Trial summary
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
- What is being tested?
- Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Scheduled for uterosacral ligament suspension (USLS)
Who cannot join
- Non-English speaking
- Prisoner
- Cognitive impairment precluding informed consent
- Planned hysteropexy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52245
About this study
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.
This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.
Read the detailed description
Patient demographics, relevant histories, baseline physical exam including POP-Q and PFDI-20 data will be abstracted from the electronic medical record following enrollment. This information will be placed into a secure database.
The randomization sequence will be generated by randomize.net, a web-based service that provides comprehensive randomization services for randomized controlled trials. The sequence will be randomized 1:1 with blocks of 4 and stratified by surgeon. Concealment will be completely opaque as group allocation will not be revealed until the subject is enrolled on the web-based service and the surgeon has elected to randomize the patient from an internet connection in the operating room.
Subjects and assessors will be blinded to study group. The surgeons will, necessarily, not be blinded. Subjects will only be informed of their assigned group upon request following completion of the entire study.
USLS with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed. All procedures will be performed by one of two fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeons. USLS will be performed as initially described by Shull et al with two important differences in technique. First, 2 sutures will be placed through the intermediate portion of each uterosacral ligament instead of 3. Second, when absorbable suture (polydioxanone) is used, the suture will be placed through the full thickness of the anterior and posterior vaginal walls.
Follow up exams will occur at 6 weeks and 12 months post-operatively and will include a POP-Q exam. The 6 week follow up visit will include the Patient Global Impression of Improvement (PGI-I) and an additional survey. The 12 month follow up visit will include a the PGI-I, PFDI-20 and an additional survey. All participants will also be assessed for any suture-related complications, such as erosion or granulation tissue. Follow up exams will be completed by one of two urogynecology nurse practitioners who will be blinded to the surgery and suture choice. Both nurse practitioners have extensive experience in performing POP-Q exams. The examiners will complete a follow up data abstraction form for each follow up appointment (6 weeks and 12 months).
The follow up clinic appointments at 6 weeks and 12 months are the times of usually scheduled post-operative follow up for USLS procedures. Additionally, completion of the PFDI-20 questionnaire and a POP-Q exam constitute routine clinical care for these patients. As such, there is no additional time commitment for subjects compared to routine clinical care.
- Conditions
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
- Being tested
- Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)Device
| Study group | Role | What they receive |
|---|---|---|
| Absorbable | Experimental | Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Receives: Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) |
| Permanent | Experimental | Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Receives: Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C
Non-inferiority of POP-Q point C. This measure was obtained as originally described by Bump et al. The hymen is used as a fixed reference point. In other words, this is point zero. Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.
Measured: 12 months
Secondary outcomes (2)
Suture-related Complications
The presence of apical granulation tissue, apical suture exposure, abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia or patient being able to feel suture.
Measured: 6 weeks and 12 months
Symptomatic Prolapse Outcomes
Positive response to PFDI-20 question #3 regarding the presence of a vaginal bulge (yes) AND the presence of bother (somewhat, moderately or quite a bit).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Kowalski
- Sponsor type
- University, hospital or other
- Collaborators
- International Urogynecological Association
- Responsible party
- Sponsor-investigator, Joseph Kowalski, University of Iowa
- Investigators
- Joseph T Kowalski, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888093
- Sponsor's protocol ID
- 201607769
- Status last verified
- Nov 2019
- First submitted
- 30 Aug 2016
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
- ClinicalTrials.gov ID
- NCT02888093
- Acronym / sponsor ID
- 201607769
- Conditions
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Joseph KowalskiUniversity, hospital or other
- Collaborators
- International Urogynecological Association
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.
This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.
Detailed description
Patient demographics, relevant histories, baseline physical exam including POP-Q and PFDI-20 data will be abstracted from the electronic medical record following enrollment. This information will be placed into a secure database.
The randomization sequence will be generated by randomize.net, a web-based service that provides comprehensive randomization services for randomized controlled trials. The sequence will be randomized 1:1 with blocks of 4 and stratified by surgeon. Concealment will be completely opaque as group allocation will not be revealed until the subject is enrolled on the web-based service and the surgeon has elected to randomize the patient from an internet connection in the operating room.
Subjects and assessors will be blinded to study group. The surgeons will, necessarily, not be blinded. Subjects will only be informed of their assigned group upon request following completion of the entire study.
USLS with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed. All procedures will be performed by one of two fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeons. USLS will be performed as initially described by Shull et al with two important differences in technique. First, 2 sutures will be placed through the intermediate portion of each uterosacral ligament instead of 3. Second, when absorbable suture (polydioxanone) is used, the suture will be placed through the full thickness of the anterior and posterior vaginal walls.
Follow up exams will occur at 6 weeks and 12 months post-operatively and will include a POP-Q exam. The 6 week follow up visit will include the Patient Global Impression of Improvement (PGI-I) and an additional survey. The 12 month follow up visit will include a the PGI-I, PFDI-20 and an additional survey. All participants will also be assessed for any suture-related complications, such as erosion or granulation tissue. Follow up exams will be completed by one of two urogynecology nurse practitioners who will be blinded to the surgery and suture choice. Both nurse practitioners have extensive experience in performing POP-Q exams. The examiners will complete a follow up data abstraction form for each follow up appointment (6 weeks and 12 months).
The follow up clinic appointments at 6 weeks and 12 months are the times of usually scheduled post-operative follow up for USLS procedures. Additionally, completion of the PFDI-20 questionnaire and a POP-Q exam constitute routine clinical care for these patients. As such, there is no additional time commitment for subjects compared to routine clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable | Experimental | Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) |
| Permanent | Experimental | Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for uterosacral ligament suspension (USLS)
Key exclusion criteria (4 listed)
- Non-English speaking
- Prisoner
- Cognitive impairment precluding informed consent
- Planned hysteropexy
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 |
|---|---|---|
| Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) | Device | Absorbable, Permanent |
Primary outcome
Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C
Time frame: 12 months
Non-inferiority of POP-Q point C. This measure was obtained as originally described by Bump et al. The hymen is used as a fixed reference point. In other words, this is point zero. Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.
2 secondary outcomes
Suture-related Complications
Time frame: 6 weeks and 12 months
Symptomatic Prolapse Outcomes
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph T Kowalski, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) in people with Pelvic Organ Prolapse and Cystocele, run by Joseph Kowalski at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.