Pelvic Organ ProlapseNCT05688059
Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension
A study testing Absorbable Suture and Permanent Suture in people with Pelvic Organ Prolapse and Uterovaginal Prolapse, run by Atlantic Health System at 1 site in United States.
Trial summary
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse
- What is being tested?
- Absorbable Suture and Permanent Suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 9 Jan 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Females
- Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers
Who cannot join
- Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
- Patients with current gynecologic malignancies
- Patients with history of pelvic radiation
- Patients with history of prolapse repair surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
Official title: Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications.
Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture.
Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.
Read the detailed description
Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system.
Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6.
Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded.
All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon.
Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed.
Follow up exams will occur at 2-4 weeks, 12 weeks and 12 months post-operatively. The follow up visits will include a POP-Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI-I questionnaire. All participants will also be assessed for any suture-related complications. 12 month POP-Q exam will be completed by one of the providers who will be blinded to the suture type.
There will be no additional follow up visits for participation in the study. The follow up appointments at 2-4 weeks, 12 weeks and 12 months are the times of usually scheduled post-operative follow up.
- Being tested
- Absorbable Suture and Permanent Suture
- Keywords
- Sacrospinous Ligament Suspension, Permanent Suture, Absorbable Suture, Efficacy, Suture-related Complications
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Suture and Permanent SutureOther
Absorbable Suture and Permanent Suture
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Suture | Experimental | Absorbable suture for sacrospinous ligament suspension Receives: Other: Absorbable Suture and Permanent Suture |
| Permanent Suture | Experimental | Permanent suture for sacrospinous ligament suspension Receives: Other: Absorbable Suture and Permanent Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.
Measured: 12 months
Secondary outcomes (3)
Prolapse Recurrence
Defined as: Prolapse symptoms reported by patient, Prolapse beyond the hymen on examination in any compartment , Apical prolapse ≥ ½ TVL, Reoperation or pessary use for prolapse during the study period
Measured: 12 months
PGI-I
patient's global impression of symptom improvement
Measured: 12 months
Suture-related Complications
presence of abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia, if they can feel sutures. On the physical exam, patients will be evaluated for apical granulation tissue, and apical suture exposure.
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 posted18 Jan 2023
- Study start6 Jan 2023
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Dhariwal, MD, Atlantic Health System
- Investigators
- Laura Dhariwal, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688059
- Sponsor's protocol ID
- 1963079-1
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013 Nov;24(11):1783-90. doi: 10.1007/s00192-013-2169-9.
PubMed 24142054Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PubMed 24807341Beer M, Kuhn A. Surgical techniques for vault prolapse: a review of the literature. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):144-55. doi: 10.1016/j.ejogrb.2004.06.042.
PubMed 15808370Tseng LH, Chen I, Chang SD, Lee CL. Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery--a systemic review. Taiwan J Obstet Gynecol. 2013 Sep;52(3):311-7. doi: 10.1016/j.tjog.2012.11.002.
PubMed 24075365Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.
PubMed 29677302Hamdy MA, Ahmed WAS, Taha OT, Abolill ZM, Elshahat AM, Aboelroose AA. Late suture site complications of sacrospinous ligament fixation. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:126-130. doi: 10.1016/j.ejogrb.2019.08.024. Epub 2019 Sep 19.
PubMed 31585239Sailesh Ray, Atin Halder, Mimi Gangopadhyay, Saswati Halder, and Partha Pratim Pal.Comparison of Two Different Suture Materials for Transvaginal Sacrospinous Fixation of the Vault: A Prospective Randomized Trial. Journal of Gynecologic Surgery.Dec 2013.281-286.http://doi.org/10.1089/gyn.2012.0150
Kowalski JT, Genadry R, Ten Eyck P, Bradley CS. A randomized controlled trial of permanent vs absorbable suture for uterosacral ligament suspension. Int Urogynecol J. 2021 Apr;32(4):785-790. doi: 10.1007/s00192-020-04244-1. Epub 2020 Feb 11.
PubMed 32047968Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.
PubMed 15902168Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.
PubMed 24618964Khin K, Holubyeva A, Gao T, Adair S, Wasenda E, Botros C, Caraballo R, Dhariwal L. Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial. Int Urogynecol J. 2026 May;37(5):1229-1235. doi: 10.1007/s00192-025-06439-w. Epub 2025 Nov 26.
PubMed 41296059
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05688059
- Acronym / sponsor ID
- 1963079-1
- Keywords
- Sacrospinous Ligament Suspension, Permanent Suture, Absorbable Suture, Efficacy, Suture-related Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 18 Jan 2023 (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.
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications.
Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture.
Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.
Detailed description
Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system.
Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6.
Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded.
All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon.
Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed.
Follow up exams will occur at 2-4 weeks, 12 weeks and 12 months post-operatively. The follow up visits will include a POP-Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI-I questionnaire. All participants will also be assessed for any suture-related complications. 12 month POP-Q exam will be completed by one of the providers who will be blinded to the suture type.
There will be no additional follow up visits for participation in the study. The follow up appointments at 2-4 weeks, 12 weeks and 12 months are the times of usually scheduled post-operative follow up.
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 Suture | Experimental | Other: Absorbable Suture and Permanent SutureAbsorbable suture for sacrospinous ligament suspension |
| Permanent Suture | Experimental | Other: Absorbable Suture and Permanent SuturePermanent suture for sacrospinous ligament suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Females
- Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers
Key exclusion criteria (4 listed)
- Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
- Patients with current gynecologic malignancies
- Patients with history of pelvic radiation
- Patients with history of prolapse repair surgery
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 |
|---|---|---|
| Absorbable Suture and Permanent SutureAbsorbable Suture and Permanent Suture | Other | Absorbable Suture, Permanent Suture |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
Time frame: 12 months
Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.
3 secondary outcomes
Prolapse Recurrence
Time frame: 12 months
PGI-I
Time frame: 12 months
Suture-related Complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 24142054Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013 Nov;24(11):1783-90. doi: 10.1007/s00192-013-2169-9.
- Background: PubMed 24807341Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
- Background: PubMed 15808370Beer M, Kuhn A. Surgical techniques for vault prolapse: a review of the literature. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):144-55. doi: 10.1016/j.ejogrb.2004.06.042.
- Background: PubMed 24075365Tseng LH, Chen I, Chang SD, Lee CL. Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery--a systemic review. Taiwan J Obstet Gynecol. 2013 Sep;52(3):311-7. doi: 10.1016/j.tjog.2012.11.002.
- Background: PubMed 29677302Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.
- Background: PubMed 31585239Hamdy MA, Ahmed WAS, Taha OT, Abolill ZM, Elshahat AM, Aboelroose AA. Late suture site complications of sacrospinous ligament fixation. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:126-130. doi: 10.1016/j.ejogrb.2019.08.024. Epub 2019 Sep 19.
- BackgroundSailesh Ray, Atin Halder, Mimi Gangopadhyay, Saswati Halder, and Partha Pratim Pal.Comparison of Two Different Suture Materials for Transvaginal Sacrospinous Fixation of the Vault: A Prospective Randomized Trial. Journal of Gynecologic Surgery.Dec 2013.281-286.http://doi.org/10.1089/gyn.2012.0150
- Background: PubMed 32047968Kowalski JT, Genadry R, Ten Eyck P, Bradley CS. A randomized controlled trial of permanent vs absorbable suture for uterosacral ligament suspension. Int Urogynecol J. 2021 Apr;32(4):785-790. doi: 10.1007/s00192-020-04244-1. Epub 2020 Feb 11.
- Background: PubMed 15902168Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.
- Background: PubMed 24618964Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.
- Derived from this study: PubMed 41296059Khin K, Holubyeva A, Gao T, Adair S, Wasenda E, Botros C, Caraballo R, Dhariwal L. Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial. Int Urogynecol J. 2026 May;37(5):1229-1235. doi: 10.1007/s00192-025-06439-w. Epub 2025 Nov 26.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Laura Dhariwal, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Suture and Permanent Suture in people with Pelvic Organ Prolapse and Uterovaginal Prolapse, run by Atlantic Health System 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 3 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 13 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (POP-Q) exam 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?
On the ClinicalTrials.gov record for NCT05688059, which also lists 11 linked publications.
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 13 Apr 2025.