Genital ProlapseNCT02050568
Mechanism of Incontinence Before and After Genital Prolapse Surgery
An observational study of Genital Prolapse, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Prolapse
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The suitable women are invited to volunteer at the outpatient clinic, at the Department of Gynaecology, at Herlev hospital.
Who may be able to join
- Women with anterior genital prolapse ≥ grade 2 (according to the pelvic-organ-prolapse quantification system (POP-Q) (19)), who are awaiting genital prolapse surgery
- or
- women with posterior genital prolapse ≥ grade 2 who are awaiting genital prolapse surgery,
Who cannot join
- Simultaneous prolapse ≥ grade 2 in the anterior or posterior part of the vagina
- Former genital prolapse surgery
- Former surgical removal of the uterus
- Former surgical treatment of urinary incontinence
- Neurological disorder
- Bladder overactivity
- Pregnancy
- Women under the age of 18
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynaecology and Obstetrics, Herlev Hospital
Herlev, 2730
About this study
Official title: Measuring the Mechanism of Incontinence With Urethral Pressure Reflectometry, Before and After Genital Prolapse Surgery
Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method stands alone in its field.
9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is characterized by a portion of the vaginal canal protruding from the opening of the vagina). However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with preoperative SUI actually experience an improvement in their condition. Efforts have been made to predict the likelihood of a patient having SUI after genital prolapse surgery; however the tests have shown disappointing positive and negative predictive values.
Read more
A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery and the sling is associated with some risks, such as bleeding and bladder injury. There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. Thus, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery.
The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery. UPR may become an important tool in the preoperative assessment, helping clinicians give better information and guidance to their patients.
Read the detailed description
Aim of the project
Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method has been validated and used in five DMSc and Ph.D. theses and stands alone in its field. (1-5)
A great percentage of women undergoing surgery for genital prolapse (characterized by a portion of the vaginal canal protruding from the opening of the vagina) develop SUI after surgery, researchers have yet to find the answer to why this occurs. Thus, there is a great need for knowledge regarding the mechanism of continence in women with genital prolapse.
The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery.
Background
Genital prolapse is a common problem for women. A Scottish study has revealed that 9.5 % of all women undergo genital prolapse surgery during their lives. (6) Unfortunately, SUI is frequently seen after this operation. A randomized study conducted amongst women with genital prolapse, without preoperative SUI, showed that 32 % developed SUI after the operation. (7) The sunken bladder, seen in genital prolapse of the anterior (front) part of the vagina, is believed to mask SUI as it leads to a kinking of the urethra and/or compression of the urethra and since the bladder is sewn into place during surgery, the kinking or compression is eliminated. (8) Urinary tract symptoms are traditionally associated with anterior genital prolapse; however, a Danish study has revealed that SUI is just as common in women after repair of genital prolapse of the posterior (back) part of the vagina, maybe even due to the same mechanisms (compression of the urethra). (9) Efforts have been made to predict the likelihood of a patient developing SUI after genital prolapse surgery, however, the most common test, has shown disappointing positive predictive values ranging from 23 % to 53 % and negative predictive values from 74 % to 86 %. (10;11)
A mid-urethral sling is gold standard for treatment of SUI. (12) To avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery. To avoid one patient from undergoing surgery for SUI, six to ten patients must be treated with a sling during their genital prolapse surgery. (13) A Dutch study conducted on 907 women, showed that 39 % of those women who already had preoperative SUI, actually experienced an improvement in their condition. Therefore, they believe it may be reasonable to await the effects of prolapse surgery instead of performing concomitant anti-incontinence surgery. (14) Also, the mid-urethral sling is associated with some risks and complications; a survey conducted on 809 women, showed that 20.9 % had postoperative complications, such as bladder injury and bleeding. (15) There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. (13;16-18) Therefore, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery.
UPR
UPR measures pressure and cross-sectional area simultaneously by means of acoustic reflectometry. A very thin and highly flexible polyurethane bag is placed in the urethra; the bag is connected to a probe by a PVC tube. A digital signal processor generates sound, which is sent from the probe into the bag. The reflections from the bag are recorded and relayed to a computer where they are converted to profiles of the urethra.
At the moment the device only exists as 3 prototypes.
Material and methods
The suitable women are expected to be included and examined over a two-year period. The participants will be informed about the study in our outpatient clinic, by a doctor. To qualify as a participant there are a set of inclusion and exclusion criteria that must be met.
With a drop-out rate of 15 %, a sample size of 30 will ensure sufficient statistical power.
Women with either anterior or posterior genital prolapse will be examined, and each group will consist of 30 women. The POP-Q system (pelvic-organ-prolapse quantification system) will be applied for grading of the genital prolapse, and the patients will be asked to complete ICIQ-SF questionnaires (International Consultation on Incontinence Questionnaire Short Form). The patients will be examined with UPR while relaxing, squeezing and straining, before and six weeks after surgery. The preoperative measurements will be conducted with and without the anterior/posterior part of the vagina held in place by a vaginal pessary. A stress test, where the women are asked to cough three times after their bladders are filled with 300 ml of saline, will also be conducted, also with and without the anterior/posterior part of the vagina held in place by a vaginal pessary.
In order to investigate the reproducibility of measurements, all preoperative examinations will be repeated in 15 women with anterior genital prolapse and 15 women with posterior genital prolapse.
- Conditions
- Genital Prolapse
- Keywords
- Genital prolapse, Genital prolapse surgery, Stress urinary incontinence, Urethral Pressure Reflectometry
- Medical subject headings
- Urinary Incontinence, Stress
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 |
|---|---|---|
| Anterior genital prolapse | Women with anterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery. | |
| Posterior genital prolapse | Women with posterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in UPR parameters before and after surgery.
The purpose is to see if and how the patients' parameters change after surgery.
Measured: Before surgery and minimum 6 weeks postoperatively.
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 startOct 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (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 Genital 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Sahar Sandra Khayyami, Herlev Hospital
- Investigators
- Niels Klarskov, MD Lecturer, Study director, University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev Hospital, DenmarkYasmine SS Khayyami, MD, Principal investigator, University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050568
- Sponsor's protocol ID
- H-4-2013-069
- Status last verified
- Mar 2015
- First submitted
- 29 Jan 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry during intra-abdominal pressure increase-an improved technique to characterize the urethral closure function in continent and stress urinary incontinent women. Neurourol Urodyn. 2013 Nov;32(8):1103-8. doi: 10.1002/nau.22368. Epub 2013 Mar 26.
PubMed 23532678Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
PubMed 22381095Aagaard M, Klarskov N, Sonksen J, Bagi P, Colstrup H, Lose G. Urethral pressure reflectometry; a novel technique for simultaneous recording of pressure and cross-sectional area: a study of feasibility in the prostatic urethra. BJU Int. 2012 Oct;110(8):1178-83. doi: 10.1111/j.1464-410X.2012.10997.x. Epub 2012 Mar 15.
PubMed 22416900Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.
PubMed 23132420Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
PubMed 21825892Abdel-Fattah M, Familusi A, Fielding S, Ford J, Bhattacharya S. Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study. BMJ Open. 2011 Nov 14;1(2):e000206. doi: 10.1136/bmjopen-2011-000206. Print 2011.
PubMed 22102637Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, Altman D. Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh. Neurourol Urodyn. 2010 Apr;29(4):527-31. doi: 10.1002/nau.20811.
PubMed 19731311Marinkovic SP, Stanton SL. Incontinence and voiding difficulties associated with prolapse. J Urol. 2004 Mar;171(3):1021-8. doi: 10.1097/01.ju.0000111782.37383.e2.
PubMed 14767263Mouritsen L, Larsen JP. Symptoms, bother and POPQ in women referred with pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):122-7. doi: 10.1007/s00192-002-1024-1. Epub 2003 Apr 26.
PubMed 12851756Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.
PubMed 18185903Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PubMed 19941278Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2012 Jul;23(7):831-41. doi: 10.1007/s00192-012-1803-2. Epub 2012 May 11.
PubMed 22576328Dwyer PL. Women with occult stress incontinence should not routinely have a mid-urethral sling with prolapse surgery. Int Urogynecol J. 2012 Jul;23(7):827-9. doi: 10.1007/s00192-012-1690-6. Epub 2012 Mar 14.
PubMed 22415701Lensen EJ, Withagen MI, Kluivers KB, Milani AL, Vierhout ME. Urinary incontinence after surgery for pelvic organ prolapse. Neurourol Urodyn. 2013 Jun;32(5):455-9. doi: 10.1002/nau.22327. Epub 2012 Sep 28.
PubMed 23024012Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol. 2005 Jul;193(1):45-52. doi: 10.1016/j.ajog.2004.11.004.
PubMed 16021057
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Mechanism of Incontinence With Urethral Pressure Reflectometry, Before and After Genital Prolapse Surgery
- ClinicalTrials.gov ID
- NCT02050568
- Acronym / sponsor ID
- H-4-2013-069
- Conditions
- Genital Prolapse
- Keywords
- Genital prolapse, Genital prolapse surgery, Stress urinary incontinence, Urethral Pressure Reflectometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- 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.
Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method stands alone in its field.
9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is characterized by a portion of the vaginal canal protruding from the opening of the vagina). However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with preoperative SUI actually experience an improvement in their condition. Efforts have been made to predict the likelihood of a patient having SUI after genital prolapse surgery; however the tests have shown disappointing positive and negative predictive values.
A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery and the sling is associated with some risks, such as bleeding and bladder injury. There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. Thus, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery.
The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery. UPR may become an important tool in the preoperative assessment, helping clinicians give better information and guidance to their patients.
Detailed description
Aim of the project
Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method has been validated and used in five DMSc and Ph.D. theses and stands alone in its field. (1-5)
A great percentage of women undergoing surgery for genital prolapse (characterized by a portion of the vaginal canal protruding from the opening of the vagina) develop SUI after surgery, researchers have yet to find the answer to why this occurs. Thus, there is a great need for knowledge regarding the mechanism of continence in women with genital prolapse.
The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery.
Background
Genital prolapse is a common problem for women. A Scottish study has revealed that 9.5 % of all women undergo genital prolapse surgery during their lives. (6) Unfortunately, SUI is frequently seen after this operation. A randomized study conducted amongst women with genital prolapse, without preoperative SUI, showed that 32 % developed SUI after the operation. (7) The sunken bladder, seen in genital prolapse of the anterior (front) part of the vagina, is believed to mask SUI as it leads to a kinking of the urethra and/or compression of the urethra and since the bladder is sewn into place during surgery, the kinking or compression is eliminated. (8) Urinary tract symptoms are traditionally associated with anterior genital prolapse; however, a Danish study has revealed that SUI is just as common in women after repair of genital prolapse of the posterior (back) part of the vagina, maybe even due to the same mechanisms (compression of the urethra). (9) Efforts have been made to predict the likelihood of a patient developing SUI after genital prolapse surgery, however, the most common test, has shown disappointing positive predictive values ranging from 23 % to 53 % and negative predictive values from 74 % to 86 %. (10;11)
A mid-urethral sling is gold standard for treatment of SUI. (12) To avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery. To avoid one patient from undergoing surgery for SUI, six to ten patients must be treated with a sling during their genital prolapse surgery. (13) A Dutch study conducted on 907 women, showed that 39 % of those women who already had preoperative SUI, actually experienced an improvement in their condition. Therefore, they believe it may be reasonable to await the effects of prolapse surgery instead of performing concomitant anti-incontinence surgery. (14) Also, the mid-urethral sling is associated with some risks and complications; a survey conducted on 809 women, showed that 20.9 % had postoperative complications, such as bladder injury and bleeding. (15) There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. (13;16-18) Therefore, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery.
UPR
UPR measures pressure and cross-sectional area simultaneously by means of acoustic reflectometry. A very thin and highly flexible polyurethane bag is placed in the urethra; the bag is connected to a probe by a PVC tube. A digital signal processor generates sound, which is sent from the probe into the bag. The reflections from the bag are recorded and relayed to a computer where they are converted to profiles of the urethra.
At the moment the device only exists as 3 prototypes.
Material and methods
The suitable women are expected to be included and examined over a two-year period. The participants will be informed about the study in our outpatient clinic, by a doctor. To qualify as a participant there are a set of inclusion and exclusion criteria that must be met.
With a drop-out rate of 15 %, a sample size of 30 will ensure sufficient statistical power.
Women with either anterior or posterior genital prolapse will be examined, and each group will consist of 30 women. The POP-Q system (pelvic-organ-prolapse quantification system) will be applied for grading of the genital prolapse, and the patients will be asked to complete ICIQ-SF questionnaires (International Consultation on Incontinence Questionnaire Short Form). The patients will be examined with UPR while relaxing, squeezing and straining, before and six weeks after surgery. The preoperative measurements will be conducted with and without the anterior/posterior part of the vagina held in place by a vaginal pessary. A stress test, where the women are asked to cough three times after their bladders are filled with 300 ml of saline, will also be conducted, also with and without the anterior/posterior part of the vagina held in place by a vaginal pessary.
In order to investigate the reproducibility of measurements, all preoperative examinations will be repeated in 15 women with anterior genital prolapse and 15 women with posterior genital prolapse.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior genital prolapse | – | –Women with anterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery. |
| Posterior genital prolapse | – | –Women with posterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The suitable women are invited to volunteer at the outpatient clinic, at the Department of Gynaecology, at Herlev hospital.
Key inclusion criteria (3 listed)
- Women with anterior genital prolapse ≥ grade 2 (according to the pelvic-organ-prolapse quantification system (POP-Q) (19)), who are awaiting genital prolapse surgery
- or
- women with posterior genital prolapse ≥ grade 2 who are awaiting genital prolapse surgery,
Key exclusion criteria (8 listed)
- Simultaneous prolapse ≥ grade 2 in the anterior or posterior part of the vagina
- Former genital prolapse surgery
- Former surgical removal of the uterus
- Former surgical treatment of urinary incontinence
- Neurological disorder
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
Changes in UPR parameters before and after surgery.
Time frame: Before surgery and minimum 6 weeks postoperatively.
The purpose is to see if and how the patients' parameters change after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: PubMed 23532678Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry during intra-abdominal pressure increase-an improved technique to characterize the urethral closure function in continent and stress urinary incontinent women. Neurourol Urodyn. 2013 Nov;32(8):1103-8. doi: 10.1002/nau.22368. Epub 2013 Mar 26.
- Background: PubMed 22381095Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
- Background: PubMed 22416900Aagaard M, Klarskov N, Sonksen J, Bagi P, Colstrup H, Lose G. Urethral pressure reflectometry; a novel technique for simultaneous recording of pressure and cross-sectional area: a study of feasibility in the prostatic urethra. BJU Int. 2012 Oct;110(8):1178-83. doi: 10.1111/j.1464-410X.2012.10997.x. Epub 2012 Mar 15.
- Background: PubMed 23132420Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.
- Background: PubMed 21825892Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
- Background: PubMed 22102637Abdel-Fattah M, Familusi A, Fielding S, Ford J, Bhattacharya S. Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study. BMJ Open. 2011 Nov 14;1(2):e000206. doi: 10.1136/bmjopen-2011-000206. Print 2011.
- Background: PubMed 19731311Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, Altman D. Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh. Neurourol Urodyn. 2010 Apr;29(4):527-31. doi: 10.1002/nau.20811.
- Background: PubMed 14767263Marinkovic SP, Stanton SL. Incontinence and voiding difficulties associated with prolapse. J Urol. 2004 Mar;171(3):1021-8. doi: 10.1097/01.ju.0000111782.37383.e2.
- Background: PubMed 12851756Mouritsen L, Larsen JP. Symptoms, bother and POPQ in women referred with pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):122-7. doi: 10.1007/s00192-002-1024-1. Epub 2003 Apr 26.
- Background: PubMed 18185903Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.
- Background: PubMed 19941278Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
- Background: PubMed 22576328Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2012 Jul;23(7):831-41. doi: 10.1007/s00192-012-1803-2. Epub 2012 May 11.
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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.
Niels Klarskov, MD Lecturer study director
University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev Hospital, Denmark
Yasmine SS Khayyami, MD principal investigator
University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev hospital, Denmark
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 Genital Prolapse, run by Herlev Hospital at 1 site in Denmark.
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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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 Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niels Klarskov, MD Lecturer (0045 38 68 14 06, niels.klarskov@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in UPR parameters before and after surgery. (time frame: Before surgery and minimum 6 weeks 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 NCT02050568, 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 18 Mar 2015.