Pelvic Organ Prolapse (POP)Phase 4SUSINCT07856654
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
A Phase 4 study testing Suzetrigine in people with Pelvic Organ Prolapse (POP) and Postoperative Pain, run by Aditi Talkad at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Postoperative Pain, Urogynecology
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ≥ 40 years and ≤ 80
- BMI >=18.0 and <= 40.0
- Can read and speak English or Spanish
- Undergoing major urogynecologic surgery, defined as having at least one of the following:
- Robotic-assisted laparoscopic sacrocolpopexy
- Uterosacral ligament suspension (laparoscopic or vaginal approach)
Show all 10Show fewer
- Uterosacral hysteropexy
- Sacrospinous hysteropexy
- Sacrospinous ligament fixation
- Conversion to laparotomy during primary surgery for prolapse repair
Who cannot join
- • Current narcotic use defined as daily use for more than 7 consecutive days in the 3 months prior to surgery, or current treatment for opioid use disorder.
- Any opioid use within 30 days prior to the scheduled procedure date.
- Significant hepatic disease, defined as AST or ALT >3 times the upper limit of normal or Child-Pugh class B or C.
- Diagnosis of chronic pain syndrome or fibromyalgia
- Inability to provide written informed consent
- History of significant respiratory, cardiovascular, metabolic, neurologic, or psychiatric disease as deemed clinically significant by study team
Show all 13Show fewer
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years or QT prolongation (QTcF >450 ms) or pacemaker/ICD
- Severe kidney disease define as Estimated glomerular filtration rate (eGFR) of ≤ 30ml/min
- Inability to receive or respond to text messages via mobile phone
- Receives transversus abdominis plane (TAP) block
- Allergy to any of the study medications
- Use of moderate or strong CYP3A inducers or inhibitors, including prescription medications, over-the-counter medications, and herbal supplements known to significantly affect CYP3A metabolism (e.g., ketoconazole, clarithromycin, rifampin, carbamazepine, phenytoin, ritonavir, and St. John's Wort).
- Pregnant or breastfeeding or planning to become pregnant within 30 days following last dose of study drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas at Austin Dell Medical School, Department of Women's Health
Austin, Texas, 78705
Aditi Talkad, MD, 404-434-3889, aditi.talkad@ascension.org
About this study
The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse.
Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome.
Read more
The main questions it aims to answer are:
- Does suzetrigine reduce postoperative pain scores compared to placebo?
- Does suzetrigine reduce the need for opioid rescue medication after surgery?
Researchers will compare participants receiving suzetrigine to participants receiving placebo, both on top of standard postoperative pain management, to see if suzetrigine lowers pain scores and opioid consumption after apical suspension surgery.
Read the detailed description
Suzetrigine is a first-in-class, selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. It was approved by the FDA in 2025 as a non-opioid alternative for moderate-to-severe pain following Phase 3 studies in abdominoplasty and bunionectomy. This single-center, randomized, double-blinded, placebo-controlled trial evaluates whether a suzetrigine-based postoperative analgesic regimen reduces opioid consumption and improves pain control compared with standard opioid-inclusive care following apical suspension surgery for pelvic organ prolapse. The study will enroll participants in a 1:1 ratio and assess pain, opioid consumption, adverse events, and patient-reported recovery over 7 days postoperatively.
- Being tested
- Suzetrigine, Placebo
- Keywords
- postoperative pain, suzetrigine, pelvic organ prolapse, urogynecology
- Medical subject headings
- Pelvic Organ Prolapse, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called Experimental Group
Suzetrigine (JOURNAVX), an oral, first-in-class, selective NaV1.8 inhibitor, administered as a 100 mg (2-tablet) loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours). Suzetrigine is FDA-approved for moderate-to-severe acute pain and provides peripheral analgesia without opioid-related CNS effects.
PlaceboDrug
Also called Control Group
Placebo, matched in appearance to suzetrigine and formulated by the site's investigational pharmacy, administered as a 2-tablet loading dose on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive suzetrigine 100 mg (2 tablets) as a loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by previously set score and based on the patient's reported pain score. Receives: Drug: Suzetrigine |
| Control Group | Experimental | Participants will receive matching placebo as a loading dose (2 tablets) on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by the patient's reported pain score. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain will be assessed using the Visual Analog Scale with change from baseline compared between patients receiving adjunctive suzetrigine versus standard multimodal postoperative pain management alone. This will assessed on a daily survey postoperatively.
Measured: Baseline (preoperative) to 7 days postoperatively
Secondary outcomes (3)
Cumulative Postoperative Opioid Consumption
Total opioid consumption, measured in morphine milligram equivalents (MME), will be assessed via daily patient-reported surveys collected through postoperative day 7 and compared between patients receiving suzetrigine versus placebo groups.
Measured: 7 days postoperatively
Patient-Reported Outcomes and Satisfaction With Postoperative Recovery
Patient-perceived control over pain management will be assessed using selected items from the American Pain Society Patient Outcome Questionnaire-Revised (APS-POQ-R), adapted for outpatient use following discharge.
Measured: 7 days postoperatively
Treatment Tolerability
Treatment tolerability, including incidence of side effects, will be assessed via daily patient-reported surveys collected through postoperative day 7 and compared between patients receiving suzetrigine versus placebo.
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, Placebo Controlled, Randomized Control Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aditi Talkad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aditi Talkad, University of Texas at Austin
- Investigators
- Amanda White, MD, Principal investigator, University of Texas at Austin Dell Medical School, Department of Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856654
- Sponsor's protocol ID
- STUDY00009223
- Acronym
- SUSI
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on individual participant data (IPD) sharing has not yet been finalized. This will be determined prior to study completion, pending institutional data-sharing policy review and consideration of participant privacy given the study's relatively small, single-site sample size.
Publications
Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
PubMed 37530822Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.
PubMed 28186223Bertoch T, D'Aunno D, McCoun J, Solanki D, Taber L, Urban J, Oswald J, Swisher MW, Tian S, Miao X, Correll DJ, Negulescu P, Bozic C, Weiner SG. Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. 2025 Jun 1;142(6):1085-1099. doi: 10.1097/ALN.0000000000005460. Epub 2025 Mar 21.
PubMed 40117446Nilsson W, Narwold E, Turner L, Shepherd J. Comparing Post-Operative Pain Outcomes in Pelvic Organ Prolapse Surgery With and Without a Hysterectomy. Int Urogynecol J. 2025 Aug;36(8):1649-1654. doi: 10.1007/s00192-025-06162-6. Epub 2025 May 10.
PubMed 40347243Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95. doi: 10.15585/mmwr.rr7103a1.
PubMed 36327391By the 2023 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria(R) for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372. Epub 2023 May 4.
PubMed 37139824Willis-Gray MG, Young JC, Pate V, Jonsson Funk M, Wu JM. Perioperative opioid prescriptions associated with stress incontinence and pelvic organ prolapse surgery. Am J Obstet Gynecol. 2020 Dec;223(6):894.e1-894.e9. doi: 10.1016/j.ajog.2020.07.004. Epub 2020 Jul 9.
PubMed 32653459Agrawal P, Choi U, Liao B, Kohn TP, Kohn J, Dumas K, Clifton M. Perioperative Pain Management With Opioid Analgesics in Colpopexy Increases Risk of New Persistent Opioid Usage. Urogynecology (Phila). 2023 Feb 1;29(2):183-190. doi: 10.1097/SPV.0000000000001305.
PubMed 36735432Swenson CW, Kamdar NS, Seiler K, Morgan DM, Lin P, As-Sanie S. Definition development and prevalence of new persistent opioid use following hysterectomy. Am J Obstet Gynecol. 2018 Nov;219(5):486.e1-486.e7. doi: 10.1016/j.ajog.2018.06.010. Epub 2018 Jun 19.
PubMed 29928864AlAshqar A, Ishiwata R, Moss C, Andersen KM, Yanek L, Bicket MC, Alexander GC, Borahay MA. Predictors of new persistent opioid use after benign hysterectomy in the United States. Am J Obstet Gynecol. 2022 Jul;227(1):68.e1-68.e24. doi: 10.1016/j.ajog.2022.02.030. Epub 2022 Mar 3.
PubMed 35248573Wright JD, Huang Y, Melamed A, Tergas AI, St Clair CM, Hou JY, Khoury-Collado F, Ananth CV, Neugut AI, Hershman DL. Use and Misuse of Opioids After Gynecologic Surgical Procedures. Obstet Gynecol. 2019 Aug;134(2):250-260. doi: 10.1097/AOG.0000000000003358.
PubMed 31306333Selle JM, Strozza DM, Branda ME, Gebhart JB, Trabuco EC, Occhino JA, Linder BJ, El Nashar SA, Madsen AM. A bundle of opioid-sparing strategies to eliminate routine opioid prescribing in a urogynecology practice. Am J Obstet Gynecol. 2024 Aug;231(2):278.e1-278.e17. doi: 10.1016/j.ajog.2024.05.043. Epub 2024 May 25.
PubMed 38801934Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25.
PubMed 28551445Yuan AS, Propst KA, Ross JH, Wallace SL, Paraiso MFR, Park AJ, Chapman GC, Ferrando CA. Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial. Am J Obstet Gynecol. 2024 Mar;230(3):340.e1-340.e13. doi: 10.1016/j.ajog.2023.10.027. Epub 2023 Oct 18.
PubMed 37863158Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
PubMed 31201808
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT07856654
- Acronym / sponsor ID
- SUSI / STUDY00009223
- Keywords
- postoperative pain, suzetrigine, pelvic organ prolapse, urogynecology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aditi TalkadUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 2 Oct 2026 (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.
The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse.
Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome.
The main questions it aims to answer are:
- Does suzetrigine reduce postoperative pain scores compared to placebo?
- Does suzetrigine reduce the need for opioid rescue medication after surgery?
Researchers will compare participants receiving suzetrigine to participants receiving placebo, both on top of standard postoperative pain management, to see if suzetrigine lowers pain scores and opioid consumption after apical suspension surgery.
Detailed description
Suzetrigine is a first-in-class, selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. It was approved by the FDA in 2025 as a non-opioid alternative for moderate-to-severe pain following Phase 3 studies in abdominoplasty and bunionectomy. This single-center, randomized, double-blinded, placebo-controlled trial evaluates whether a suzetrigine-based postoperative analgesic regimen reduces opioid consumption and improves pain control compared with standard opioid-inclusive care following apical suspension surgery for pelvic organ prolapse. The study will enroll participants in a 1:1 ratio and assess pain, opioid consumption, adverse events, and patient-reported recovery over 7 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double Blind, Placebo Controlled, Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: SuzetrigineParticipants will receive suzetrigine 100 mg (2 tablets) as a loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by previously set score and based on the patient's reported pain score. |
| Control Group | Experimental | Drug: PlaceboParticipants will receive matching placebo as a loading dose (2 tablets) on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by the patient's reported pain score. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women ≥ 40 years and ≤ 80
- BMI >=18.0 and <= 40.0
- Can read and speak English or Spanish
- Undergoing major urogynecologic surgery, defined as having at least one of the following:
Key exclusion criteria (13 listed)
- • Current narcotic use defined as daily use for more than 7 consecutive days in the 3 months prior to surgery, or current treatment for opioid use disorder.
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 |
|---|---|---|
| SuzetrigineAlso: Experimental GroupSuzetrigine (JOURNAVX), an oral, first-in-class, selective NaV1.8 inhibitor, administered as a 100 mg (2-tablet) loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours). Suzetrigine is FDA-approved for moderate-to-severe acute pain and provides peripheral analgesia without opioid-related CNS effects. | Drug | Experimental Group |
| PlaceboAlso: Control GroupPlacebo, matched in appearance to suzetrigine and formulated by the site's investigational pharmacy, administered as a 2-tablet loading dose on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours). | Drug | Control Group |
Primary outcome
Postoperative Pain Score
Time frame: Baseline (preoperative) to 7 days postoperatively
Postoperative pain will be assessed using the Visual Analog Scale with change from baseline compared between patients receiving adjunctive suzetrigine versus standard multimodal postoperative pain management alone. This will assessed on a daily survey postoperatively.
3 secondary outcomes
Cumulative Postoperative Opioid Consumption
Time frame: 7 days postoperatively
Patient-Reported Outcomes and Satisfaction With Postoperative Recovery
Time frame: 7 days postoperatively
Treatment Tolerability
Time frame: 7 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 37530822Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
- Background: PubMed 28186223Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.
- Background: PubMed 40117446Bertoch T, D'Aunno D, McCoun J, Solanki D, Taber L, Urban J, Oswald J, Swisher MW, Tian S, Miao X, Correll DJ, Negulescu P, Bozic C, Weiner SG. Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. 2025 Jun 1;142(6):1085-1099. doi: 10.1097/ALN.0000000000005460. Epub 2025 Mar 21.
- Background: PubMed 40347243Nilsson W, Narwold E, Turner L, Shepherd J. Comparing Post-Operative Pain Outcomes in Pelvic Organ Prolapse Surgery With and Without a Hysterectomy. Int Urogynecol J. 2025 Aug;36(8):1649-1654. doi: 10.1007/s00192-025-06162-6. Epub 2025 May 10.
- Background: PubMed 36327391Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95. doi: 10.15585/mmwr.rr7103a1.
- Background: PubMed 37139824By the 2023 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria(R) for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372. Epub 2023 May 4.
- Background: PubMed 32653459Willis-Gray MG, Young JC, Pate V, Jonsson Funk M, Wu JM. Perioperative opioid prescriptions associated with stress incontinence and pelvic organ prolapse surgery. Am J Obstet Gynecol. 2020 Dec;223(6):894.e1-894.e9. doi: 10.1016/j.ajog.2020.07.004. Epub 2020 Jul 9.
- Background: PubMed 36735432Agrawal P, Choi U, Liao B, Kohn TP, Kohn J, Dumas K, Clifton M. Perioperative Pain Management With Opioid Analgesics in Colpopexy Increases Risk of New Persistent Opioid Usage. Urogynecology (Phila). 2023 Feb 1;29(2):183-190. doi: 10.1097/SPV.0000000000001305.
- Background: PubMed 29928864Swenson CW, Kamdar NS, Seiler K, Morgan DM, Lin P, As-Sanie S. Definition development and prevalence of new persistent opioid use following hysterectomy. Am J Obstet Gynecol. 2018 Nov;219(5):486.e1-486.e7. doi: 10.1016/j.ajog.2018.06.010. Epub 2018 Jun 19.
- Background: PubMed 35248573AlAshqar A, Ishiwata R, Moss C, Andersen KM, Yanek L, Bicket MC, Alexander GC, Borahay MA. Predictors of new persistent opioid use after benign hysterectomy in the United States. Am J Obstet Gynecol. 2022 Jul;227(1):68.e1-68.e24. doi: 10.1016/j.ajog.2022.02.030. Epub 2022 Mar 3.
- Background: PubMed 31306333Wright JD, Huang Y, Melamed A, Tergas AI, St Clair CM, Hou JY, Khoury-Collado F, Ananth CV, Neugut AI, Hershman DL. Use and Misuse of Opioids After Gynecologic Surgical Procedures. Obstet Gynecol. 2019 Aug;134(2):250-260. doi: 10.1097/AOG.0000000000003358.
- Background: PubMed 38801934Selle JM, Strozza DM, Branda ME, Gebhart JB, Trabuco EC, Occhino JA, Linder BJ, El Nashar SA, Madsen AM. A bundle of opioid-sparing strategies to eliminate routine opioid prescribing in a urogynecology practice. Am J Obstet Gynecol. 2024 Aug;231(2):278.e1-278.e17. doi: 10.1016/j.ajog.2024.05.043. Epub 2024 May 25.
- Individual participant dataSharing planned: Undecided. A decision on individual participant data (IPD) sharing has not yet been finalized. This will be determined prior to study completion, pending institutional data-sharing policy review and consideration of participant privacy given the study's relatively small, single-site sample size.
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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.
Amanda White, MD principal investigator
University of Texas at Austin Dell Medical School, Department of Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine in people with Pelvic Organ Prolapse (POP) and Postoperative Pain, run by Aditi Talkad 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aditi Talkad MD (404-434-3889, aditi.talkad@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: Baseline (preoperative) to 7 days postoperatively). 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 NCT07856654, which also lists 20 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 2 Oct 2026.