Pelvic Organ ProlapseNCT02049996
Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
An observational study of Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- 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 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been scheduled for a vaginal hysterectomy with either vaginal or robot-assisted prolapse repairs with Cincinnati Urogynecology Associates will be approached for participation in the study. Eligible subjects are patients of Cincinnati Urogynecology Associates, aged 18-90, planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse, as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal. All subjects will undergo general anesthesia. Eligible subjects must be able to speak and read English, and be able to understand the informed consent statement.
Who may be able to join
- patients of Cincinnati Urogynecology Associates
- aged 18-90
- planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal.
- undergoing general anesthesia
- able to speak and read English
- able to understand the informed consent statement
Who cannot join
- scheduled for repairs not involving a hysterectomy
- use of mesh in the vaginal prolapse repair
- obliterative procedures to the vagina
- concurrent removal of a suburethral sling
- anterior, posterior or apical vaginal mesh kit at the time of their surgery
- performance of vaginal 'relaxing incisions' at the time of vaginal surgery
Show all 9Show fewer
- concurrent anal incontinence repair such as a sphincteroplasty
- presence of uterine, cervical or ovarian malignancy
- use of regional anesthesia for their surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Is There a Difference in Pain and Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Compared to Robotic Colpopexy? A Prospective Cohort Study
The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair.
We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.
Read the detailed description
Since the introduction of the DaVinci robotic system (Intuitive Surgical, Sunnyvale, CA), there has been considerable debate regarding its use, cost-effectiveness, and subsequent impact on patient care. While some studies have examined surgical outcomes and analyzed costs of this technique compared to open, laparoscopic, and vaginal approaches, it remains unclear whether one route is superior.
Indeed, data evaluating robotic-assisted and laparoscopic approaches to hysterectomy have shown similar patient results, but some reports note higher costs and longer operating times with robotics. Others suggest contrary information, with comparable surgical time, reduced blood loss, shorter hospital stay, and lower rate of conversion to laparotomy using robotic-assisted hysterectomy compared to laparoscopic or abdominal. Research contrasting robot-assisted laparoscopic myomectomy with abdominal myomectomy posit greater cost associated with the robotic procedure, but enhanced benefit of decreased blood loss, complication rates, and length of stay.
However, these issues have not been explored in urogynecologic patients. A single study comparing robotic versus vaginal urogynecologic procedures in elderly women showed robotic surgery to be associated with fewer postoperative complications than the vaginal route. Nevertheless the procedures were not always performed in conjunction with hysterectomy, and the analysis was retrospective.
In our practice, vaginal hysterectomy is the preferred method when correcting uterovaginal prolapse. We then address the reconstruction either vaginally or robotically. Vaginal repairs are comprised of the following: a vaginal vault suspension using the uterosacral ligaments, enterocele repair, anterior repair, and posterior/rectocele repair. The robotic procedure performed is a robotic sacral colpopexy using lightweight, polypropylene mesh, as well as a posterior/rectocele repair transvaginally. Both of these techniques are well-researched, effective approaches to addressing prolapse in a durable way. However, it is not clear whether one is superior in patient-related quality of life outcomes. We seek to compare patient quality of life by assessing differences in subjective impressions of pain following these procedures
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Quality of life, Robotic surgery, Vaginal surgery, Prolapse repair, Vaginal hysterectomy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted prolapse repair | Subjects already scheduled for robotic-assisted prolapse repair in conjunction with vaginal hysterectomy | |
| Vaginal prolapse repair | Subjects already scheduled for vaginal prolapse repair in conjunction with vaginal hysterectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of pain on the morning of post-operative day 1
Subjective assessment of pain on the morning of post-operative day 1, prior to discharge, on a 150 mm visual analog scale (Surgical Pain Scale) The average pain that day at rest and the WORST pain that day will be the primary outcomes of pain.
Measured: One day (the day after surgery)
Secondary outcomes (12)
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit on a 150 mm visual analog scale (Surgical Pain Scale).
Measured: 2 week postoperative visit
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit on a 150 mm visual analog scale (Surgical Pain Scale).
Measured: 6 week postoperative visit
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
Measured: 1 day (Baseline, day of surgery)
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
Measured: 2 week postoperative visit
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
Measured: 6 week postoperative visit
Intraoperative time
Length of surgery
Measured: Intraoperative
Estimated blood loss
Estimated blood loss during surgery.
Measured: Intraoperative
Surgical complications
Complications that occur during surgery.
Measured: Intraoperative
Voiding trial results
Results of voiding trial which assesses postoperative bladder function.
Measured: 1 day (day after surgery)
Hospital length of stay
Length of stay in the hospital for surgery and postoperative care.
Measured: 1-2 days
POP-Q preoperatively and postoperatively
Comparison measurement of prolapse using pelvic organ prolapse quantification scale (POP-Q) preoperatively and postoperatively.
Measured: several weeks
Hemoglobin/hematocrit measurement
Measurement of blood count (hemoglobin/hematocrit levels) on postoperative day 1.
Measured: 1 day (postoperative day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren B. Westermann, DO, Principal investigator, TriHealth Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049996
- Sponsor's protocol ID
- 13090-13-060
- Status last verified
- Sep 2016
- First submitted
- 28 Jan 2014
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.
PubMed 18439499Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.
PubMed 19793478Orady M, Hrynewych A, Nawfal AK, Wegienka G. Comparison of robotic-assisted hysterectomy to other minimally invasive approaches. JSLS. 2012 Oct-Dec;16(4):542-8. doi: 10.4293/108680812X13462882736899.
PubMed 23484561Advincula AP, Xu X, Goudeau S 4th, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):698-705. doi: 10.1016/j.jmig.2007.06.008.
PubMed 17980329Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
PubMed 8694033McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. doi: 10.1016/j.jamcollsurg.2005.03.034.
PubMed 16038823Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
PubMed 9817135Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
PubMed 20207063Saceanu S, Cela V, Surlin V, Angelescu CM, Patrascu S, Georgescu I, Genazzani A. Hysterectomy for benign uterine pathology: comparison between robotic assisted laparoscopy, classic laparoscopy and laparotomy. Chirurgia (Bucur). 2013 May-Jun;108(3):346-50.
PubMed 23790783Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013 Jan-Mar;17(1):100-6. doi: 10.4293/108680812X13517013317914.
PubMed 23743379Robinson BL, Parnell BA, Sandbulte JT, Geller EJ, Connolly A, Matthews CA. Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of perioperative complications in elderly women. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):230-7. doi: 10.1097/SPV.0b013e318299a66c.
PubMed 23797528Crisp CC, Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, Estanol MV, Fellner AN, Pauls RN. Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 10.1016/j.ajog.2012.06.040. Epub 2012 Jun 20.
PubMed 22863282Westermann LB, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):95-100. doi: 10.1097/SPV.0000000000000368.
PubMed 28067743
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference in Pain and Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Compared to Robotic Colpopexy? A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02049996
- Acronym / sponsor ID
- 13090-13-060
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Quality of life, Robotic surgery, Vaginal surgery, Prolapse repair, Vaginal hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 2014 (estimated)
- 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 purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair.
We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.
Detailed description
Since the introduction of the DaVinci robotic system (Intuitive Surgical, Sunnyvale, CA), there has been considerable debate regarding its use, cost-effectiveness, and subsequent impact on patient care. While some studies have examined surgical outcomes and analyzed costs of this technique compared to open, laparoscopic, and vaginal approaches, it remains unclear whether one route is superior.
Indeed, data evaluating robotic-assisted and laparoscopic approaches to hysterectomy have shown similar patient results, but some reports note higher costs and longer operating times with robotics. Others suggest contrary information, with comparable surgical time, reduced blood loss, shorter hospital stay, and lower rate of conversion to laparotomy using robotic-assisted hysterectomy compared to laparoscopic or abdominal. Research contrasting robot-assisted laparoscopic myomectomy with abdominal myomectomy posit greater cost associated with the robotic procedure, but enhanced benefit of decreased blood loss, complication rates, and length of stay.
However, these issues have not been explored in urogynecologic patients. A single study comparing robotic versus vaginal urogynecologic procedures in elderly women showed robotic surgery to be associated with fewer postoperative complications than the vaginal route. Nevertheless the procedures were not always performed in conjunction with hysterectomy, and the analysis was retrospective.
In our practice, vaginal hysterectomy is the preferred method when correcting uterovaginal prolapse. We then address the reconstruction either vaginally or robotically. Vaginal repairs are comprised of the following: a vaginal vault suspension using the uterosacral ligaments, enterocele repair, anterior repair, and posterior/rectocele repair. The robotic procedure performed is a robotic sacral colpopexy using lightweight, polypropylene mesh, as well as a posterior/rectocele repair transvaginally. Both of these techniques are well-researched, effective approaches to addressing prolapse in a durable way. However, it is not clear whether one is superior in patient-related quality of life outcomes. We seek to compare patient quality of life by assessing differences in subjective impressions of pain following these procedures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted prolapse repair | – | –Subjects already scheduled for robotic-assisted prolapse repair in conjunction with vaginal hysterectomy |
| Vaginal prolapse repair | – | –Subjects already scheduled for vaginal prolapse repair in conjunction with vaginal hysterectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been scheduled for a vaginal hysterectomy with either vaginal or robot-assisted prolapse repairs with Cincinnati Urogynecology Associates will be approached for participation in the study. Eligible subjects are patients of Cincinnati Urogynecology Associates, aged 18-90, planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse, as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal. All subjects will undergo general anesthesia. Eligible subjects must be able to speak and read English, and be able to understand the informed consent statement.
Key inclusion criteria (6 listed)
- patients of Cincinnati Urogynecology Associates
- aged 18-90
- planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal.
- undergoing general anesthesia
- able to speak and read English
Key exclusion criteria (9 listed)
- scheduled for repairs not involving a hysterectomy
- use of mesh in the vaginal prolapse repair
- obliterative procedures to the vagina
- concurrent removal of a suburethral sling
- anterior, posterior or apical vaginal mesh kit at the time of their surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective assessment of pain on the morning of post-operative day 1
Time frame: One day (the day after surgery)
Subjective assessment of pain on the morning of post-operative day 1, prior to discharge, on a 150 mm visual analog scale (Surgical Pain Scale) The average pain that day at rest and the WORST pain that day will be the primary outcomes of pain.
12 secondary outcomes
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
Time frame: 2 week postoperative visit
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
Time frame: 6 week postoperative visit
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit
Time frame: 1 day (Baseline, day of surgery)
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
Time frame: 2 week postoperative visit
Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
Time frame: 6 week postoperative visit
Intraoperative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Surgical complications
Time frame: Intraoperative
Voiding trial results
Time frame: 1 day (day after surgery)
Hospital length of stay
Time frame: 1-2 days
POP-Q preoperatively and postoperatively
Time frame: several weeks
Hemoglobin/hematocrit measurement
Time frame: 1 day (postoperative day 1)
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 9 Sep 2016.
- Background: PubMed 18439499Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.
- Background: PubMed 19793478Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.
- Background: PubMed 23484561Orady M, Hrynewych A, Nawfal AK, Wegienka G. Comparison of robotic-assisted hysterectomy to other minimally invasive approaches. JSLS. 2012 Oct-Dec;16(4):542-8. doi: 10.4293/108680812X13462882736899.
- Background: PubMed 17980329Advincula AP, Xu X, Goudeau S 4th, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):698-705. doi: 10.1016/j.jmig.2007.06.008.
- Background: PubMed 8694033Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
- Background: PubMed 16038823McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. doi: 10.1016/j.jamcollsurg.2005.03.034.
- Background: PubMed 9817135Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
- Results publication: PubMed 20207063Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
- Results publication: PubMed 23790783Saceanu S, Cela V, Surlin V, Angelescu CM, Patrascu S, Georgescu I, Genazzani A. Hysterectomy for benign uterine pathology: comparison between robotic assisted laparoscopy, classic laparoscopy and laparotomy. Chirurgia (Bucur). 2013 May-Jun;108(3):346-50.
- Results publication: PubMed 23743379Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013 Jan-Mar;17(1):100-6. doi: 10.4293/108680812X13517013317914.
- Results publication: PubMed 23797528Robinson BL, Parnell BA, Sandbulte JT, Geller EJ, Connolly A, Matthews CA. Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of perioperative complications in elderly women. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):230-7. doi: 10.1097/SPV.0b013e318299a66c.
- Results publication: PubMed 22863282Crisp CC, Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, Estanol MV, Fellner AN, Pauls RN. Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 10.1016/j.ajog.2012.06.040. Epub 2012 Jun 20.
- 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.
Lauren B. Westermann, DO principal investigator
TriHealth Good Samaritan Hospital
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 TriHealth Inc. 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 6 inclusion and 9 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 9 Sep 2016. 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?
Subjective assessment of pain on the morning of post-operative day 1 (time frame: One day (the day after surgery)). 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 NCT02049996, which also lists 13 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 9 Sep 2016.