NocturiaSOPPONCT02060331
Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
An observational study of Nocturia and Pelvic Organ Prolapse, run by Loyola University at 1 site in United States.
Trial summary
In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia, Pelvic Organ Prolapse
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulatory Urogynecology Clinic
Who may be able to join
- Female gender
- Bothersome nocturia (presence of ≥1 void per night averaged over 4 weeks with ≥5/10 on 0-10 bother scale)
- Age >18 years
- Apical stage III-IV pelvic organ prolapse as defined by the Pelvic Organ Prolapse Quantification (POP-Q) Staging Criteria: Stage III - leading edge > +1 cm but < +(total vaginal length-2) cm, Stage IV - leading edge ≥ +(tvl-2) cm
- Undergoing surgical correction (colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension) for POP by Drs. Mueller, Brincat, and/or Brubaker
Who cannot join
- Obstructive sleep apnea (clinically diagnosed on sleep study or patients with excessive daytime sleepiness or nighttime apneic periods as identified by patient or spouse)
- Diuretic use (ie for hypertension)
- Renal insufficiency (Chronic Kidney Disease Stage 3-5, measured or estimated Glomerular Filtration Rate <60) as determined by history and/or serum basic metabolic panel
- Neurogenic detrusor hyperreflexia, detrusor areflexia, detrusor sphincter dyssynergia, chronic urinary catheterization
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators hypothesize that in some women compression of the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that prolapse while the patient lays supine overnight results in nighttime post-obstructive diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes obstruction due to descent of the bladder floor which leads to compression of the bilateral ureters between the uterus and the borders of the genital opening. No large prospective studies, however, have evaluated the possible impact of this phenomenon on patients or the possible post-operative changes following surgical correction of POP.
Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries, and urine studies, the investigators aim to evaluate the pre-operative and post-operative voiding habits and urinary parameters of women with severe pelvic organ prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients with >90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also offer high rates of success. The investigators aim to determine whether surgical correction of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension, results in improvement and/or resolution of nocturia and post-obstructive diuresis.
Read the detailed description
- Significance or Clinical Relevance of Project: Numerous women undergo pelvic organ prolapse surgery every year. The most common reasons for surgical management of POP include symptoms immediately related to the prolapsing organs, such as pelvic pressure, vaginal bulge sensation, vaginal mucosal irritation, as well as defecatory dysfunction, limitations on sexual intercourse, and aesthetic dissatisfaction. When counseling patients about possible surgical management of POP, clinicians would be remiss if they did not address the potential quality of life improvement surgery may provide from a urinary standpoint, as well as possible decreased risk of renal failure. Stress and urge incontinence and urinary urgency are frequently alleviated by restoration of the pelvic floor support, however, nocturia may be treated as well.
- Relevant Research of Others: Several case reports exist describing urinary obstruction, bilateral hydronephrosis, and acute or chronic renal failure that can occur with severe pelvic organ prolapse. No larger scale prospective descriptive studies exist, however, demonstrating the urinary symptoms or pathophysiology behind the urinary tract obstruction that may accompany pelvic organ prolapse. Also, no prospective studies exist to evaluate the improvement in those symptoms and relief of physiologic obstruction after surgical correction of pelvic organ prolapse.
- Methods/Materials:
Women referred to the urogynecology clinic for management of apical Stage III-IV POP with bothersome nocturia as noted in their initial urogynecologic evaluation who opt for surgical management will be identified for inclusion in the study. In addition to routine urogynecologic and pre-operative work-up, after consenting for the study, they will be asked to complete pre- and post-operative Nocturia, Nocturnal Enuresis, and Sleep interruption Questionnaires (NNES-Q) (appendix), voiding diaries (appendix), and awake and asleep renal nocturia urine panels. Women will serve as their own pre- and post-operative control subjects.
Enrolled patients will be educated on how to perform the voiding diary and awake and asleep renal nocturia urine panel. The voiding diary will require the patient to measure the date, time, voided urine amount (using a urine hat placed over a toilet), degree of incontinence (dry, moist, soaked), presence or absence of urge to urinate, activity immediately prior to urination episode, and fluid intake for three non-consecutive twenty-four hour periods. The awake and asleep renal nocturia urine panels will require the patient to collect her urine output into two laboratory provided basins for one twenty-four hour period. The "renal nocturia, awake" urine panel will be obtained from urine collected from 0600-1800. The "renal nocturia, asleep" urine panel will be obtained from urine collected from 1800-0600, ie through the following day.
Six to thirteen weeks post-operatively, enrolled patients will be asked to repeat the NNES-Q questionnaire, voiding diary, and awake and asleep renal nocturia urine panels as described above.
Patients who complete all of the aforementioned questionnaires and studies will be reimbursed with a $25 check. This compensation will be disclosed to potential study candidates prior to enrollment in the study.
The data obtained will be de-identified and then entered into SPSS v. 20 software for statistical analysis.
- Conditions
- Nocturia, Pelvic Organ Prolapse
- Keywords
- Nocturia, Pelvic Organ Prolapse, Nocturnal Polyuria, Post-obstructive Diuresis
- Medical subject headings
- Nocturia, 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 |
|---|---|---|
| Pelvic Organ Prolapse with Nocturia | Pelvic Organ Prolapse with Nocturia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia.
To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate significant symptomatic improvement in nocturia as measured by the NNES-Q questionnaire.
Measured: 1 year
Secondary outcomes (2)
Impact of surgical treatment of apical pelvic organ prolapse on nocturnal polyuria.
To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate a significant post-operative improvement in their nocturnal polyuria based on voiding diaries.
Measured: 1 year
Impact of surgical treatment of apical pelvic organ prolapse on urine osmolality parameters.
To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate a significant post-operative improvement in their ability to concentrate urine based on urine osmolality parameters.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014 (estimated)
Why it stopped: Difficult to recruit to.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mueller, Loyola University
- Investigators
- Elizabeth Mueller, MD, Principal investigator, Loyola University Medical Center Department of Urology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060331
- Sponsor's protocol ID
- 206058
- Acronym
- SOPPO
- Status last verified
- Jun 2016
- First submitted
- 10 Feb 2014
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Madersbacher S, Cornu JN. Nocturnal polyuria: it's all about definition, and be Patient! Eur Urol. 2013 Mar;63(3):548-50. doi: 10.1016/j.eururo.2012.10.043. Epub 2012 Nov 2. No abstract available.
PubMed 23141934Yanik FF, Akpolat T, Kocak I. Acute renal failure--an unusual consequence of uterine prolapse. Nephrol Dial Transplant. 1998 Oct;13(10):2648-50. doi: 10.1093/ndt/13.10.2648. No abstract available.
PubMed 9794579Gomes CM, Rovner ES, Banner MP, Ramchandani P, Wein AJ. Simultaneous upper and lower urinary tract obstruction associated with severe genital prolapse: diagnosis and evaluation with magnetic resonance imaging. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(2):144-6. doi: 10.1007/s001920170082.
PubMed 11374515Beverly CM, Walters MD, Weber AM, Piedmonte MR, Ballard LA. Prevalence of hydronephrosis in patients undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 1997 Jul;90(1):37-41. doi: 10.1016/S0029-7844(97)00240-8.
PubMed 9207809Abbasy S, Kenton K. Obliterative procedures for pelvic organ prolapse. Clin Obstet Gynecol. 2010 Mar;53(1):86-98. doi: 10.1097/GRF.0b013e3181cd4252.
PubMed 20142646Bing MH, Moller LA, Jennum P, Mortensen S, Lose G. Validity and reliability of a questionnaire for evaluating nocturia, nocturnal enuresis and sleep-interruptions in an elderly population. Eur Urol. 2006 Apr;49(4):710-9. doi: 10.1016/j.eururo.2005.11.034. Epub 2006 Jan 13.
PubMed 16442700Chuang FR, Lee CH, Chen CS, Weng HH, Wang IK. Bilateral moderate hydroureteronephrosis due to uterine prolapse: two case reports and review of the literature. Ren Fail. 2003 Sep;25(5):879-84. doi: 10.1081/jdi-120024303.
PubMed 14575296Floyd MS Jr, Casey RG, Bredin HC. Procidentia: a reversible cause of hydronephrosis in an 80-year-old woman. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1179-81. doi: 10.1007/s00192-008-0587-x. Epub 2008 Mar 11.
PubMed 18330482
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
- ClinicalTrials.gov ID
- NCT02060331
- Acronym / sponsor ID
- SOPPO / 206058
- Conditions
- Nocturia, Pelvic Organ Prolapse
- Keywords
- Nocturia, Pelvic Organ Prolapse, Nocturnal Polyuria, Post-obstructive Diuresis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit to.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (estimated)
- First posted
- 12 Feb 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.
In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators hypothesize that in some women compression of the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that prolapse while the patient lays supine overnight results in nighttime post-obstructive diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes obstruction due to descent of the bladder floor which leads to compression of the bilateral ureters between the uterus and the borders of the genital opening. No large prospective studies, however, have evaluated the possible impact of this phenomenon on patients or the possible post-operative changes following surgical correction of POP.
Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries, and urine studies, the investigators aim to evaluate the pre-operative and post-operative voiding habits and urinary parameters of women with severe pelvic organ prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients with >90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also offer high rates of success. The investigators aim to determine whether surgical correction of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension, results in improvement and/or resolution of nocturia and post-obstructive diuresis.
Detailed description
- Significance or Clinical Relevance of Project: Numerous women undergo pelvic organ prolapse surgery every year. The most common reasons for surgical management of POP include symptoms immediately related to the prolapsing organs, such as pelvic pressure, vaginal bulge sensation, vaginal mucosal irritation, as well as defecatory dysfunction, limitations on sexual intercourse, and aesthetic dissatisfaction. When counseling patients about possible surgical management of POP, clinicians would be remiss if they did not address the potential quality of life improvement surgery may provide from a urinary standpoint, as well as possible decreased risk of renal failure. Stress and urge incontinence and urinary urgency are frequently alleviated by restoration of the pelvic floor support, however, nocturia may be treated as well.
- Relevant Research of Others: Several case reports exist describing urinary obstruction, bilateral hydronephrosis, and acute or chronic renal failure that can occur with severe pelvic organ prolapse. No larger scale prospective descriptive studies exist, however, demonstrating the urinary symptoms or pathophysiology behind the urinary tract obstruction that may accompany pelvic organ prolapse. Also, no prospective studies exist to evaluate the improvement in those symptoms and relief of physiologic obstruction after surgical correction of pelvic organ prolapse.
- Methods/Materials:
Women referred to the urogynecology clinic for management of apical Stage III-IV POP with bothersome nocturia as noted in their initial urogynecologic evaluation who opt for surgical management will be identified for inclusion in the study. In addition to routine urogynecologic and pre-operative work-up, after consenting for the study, they will be asked to complete pre- and post-operative Nocturia, Nocturnal Enuresis, and Sleep interruption Questionnaires (NNES-Q) (appendix), voiding diaries (appendix), and awake and asleep renal nocturia urine panels. Women will serve as their own pre- and post-operative control subjects.
Enrolled patients will be educated on how to perform the voiding diary and awake and asleep renal nocturia urine panel. The voiding diary will require the patient to measure the date, time, voided urine amount (using a urine hat placed over a toilet), degree of incontinence (dry, moist, soaked), presence or absence of urge to urinate, activity immediately prior to urination episode, and fluid intake for three non-consecutive twenty-four hour periods. The awake and asleep renal nocturia urine panels will require the patient to collect her urine output into two laboratory provided basins for one twenty-four hour period. The "renal nocturia, awake" urine panel will be obtained from urine collected from 0600-1800. The "renal nocturia, asleep" urine panel will be obtained from urine collected from 1800-0600, ie through the following day.
Six to thirteen weeks post-operatively, enrolled patients will be asked to repeat the NNES-Q questionnaire, voiding diary, and awake and asleep renal nocturia urine panels as described above.
Patients who complete all of the aforementioned questionnaires and studies will be reimbursed with a $25 check. This compensation will be disclosed to potential study candidates prior to enrollment in the study.
The data obtained will be de-identified and then entered into SPSS v. 20 software for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Organ Prolapse with Nocturia | – | –Pelvic Organ Prolapse with Nocturia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory Urogynecology Clinic
Key inclusion criteria (5 listed)
- Female gender
- Bothersome nocturia (presence of ≥1 void per night averaged over 4 weeks with ≥5/10 on 0-10 bother scale)
- Age >18 years
- Apical stage III-IV pelvic organ prolapse as defined by the Pelvic Organ Prolapse Quantification (POP-Q) Staging Criteria: Stage III - leading edge > +1 cm but < +(total vaginal length-2) cm, Stage IV - leading edge ≥ +(tvl-2) cm
- Undergoing surgical correction (colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension) for POP by Drs. Mueller, Brincat, and/or Brubaker
Key exclusion criteria (4 listed)
- Obstructive sleep apnea (clinically diagnosed on sleep study or patients with excessive daytime sleepiness or nighttime apneic periods as identified by patient or spouse)
- Diuretic use (ie for hypertension)
- Renal insufficiency (Chronic Kidney Disease Stage 3-5, measured or estimated Glomerular Filtration Rate <60) as determined by history and/or serum basic metabolic panel
- Neurogenic detrusor hyperreflexia, detrusor areflexia, detrusor sphincter dyssynergia, chronic urinary catheterization
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
Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia.
Time frame: 1 year
To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate significant symptomatic improvement in nocturia as measured by the NNES-Q questionnaire.
2 secondary outcomes
Impact of surgical treatment of apical pelvic organ prolapse on nocturnal polyuria.
Time frame: 1 year
Impact of surgical treatment of apical pelvic organ prolapse on urine osmolality parameters.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Background: PubMed 23141934Madersbacher S, Cornu JN. Nocturnal polyuria: it's all about definition, and be Patient! Eur Urol. 2013 Mar;63(3):548-50. doi: 10.1016/j.eururo.2012.10.043. Epub 2012 Nov 2. No abstract available.
- Background: PubMed 9794579Yanik FF, Akpolat T, Kocak I. Acute renal failure--an unusual consequence of uterine prolapse. Nephrol Dial Transplant. 1998 Oct;13(10):2648-50. doi: 10.1093/ndt/13.10.2648. No abstract available.
- Background: PubMed 11374515Gomes CM, Rovner ES, Banner MP, Ramchandani P, Wein AJ. Simultaneous upper and lower urinary tract obstruction associated with severe genital prolapse: diagnosis and evaluation with magnetic resonance imaging. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(2):144-6. doi: 10.1007/s001920170082.
- Background: PubMed 9207809Beverly CM, Walters MD, Weber AM, Piedmonte MR, Ballard LA. Prevalence of hydronephrosis in patients undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 1997 Jul;90(1):37-41. doi: 10.1016/S0029-7844(97)00240-8.
- Background: PubMed 20142646Abbasy S, Kenton K. Obliterative procedures for pelvic organ prolapse. Clin Obstet Gynecol. 2010 Mar;53(1):86-98. doi: 10.1097/GRF.0b013e3181cd4252.
- Background: PubMed 16442700Bing MH, Moller LA, Jennum P, Mortensen S, Lose G. Validity and reliability of a questionnaire for evaluating nocturia, nocturnal enuresis and sleep-interruptions in an elderly population. Eur Urol. 2006 Apr;49(4):710-9. doi: 10.1016/j.eururo.2005.11.034. Epub 2006 Jan 13.
- Background: PubMed 14575296Chuang FR, Lee CH, Chen CS, Weng HH, Wang IK. Bilateral moderate hydroureteronephrosis due to uterine prolapse: two case reports and review of the literature. Ren Fail. 2003 Sep;25(5):879-84. doi: 10.1081/jdi-120024303.
- Background: PubMed 18330482Floyd MS Jr, Casey RG, Bredin HC. Procidentia: a reversible cause of hydronephrosis in an 80-year-old woman. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1179-81. doi: 10.1007/s00192-008-0587-x. Epub 2008 Mar 11.
- 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.
Elizabeth Mueller, MD principal investigator
Loyola University Medical Center Department of Urology and Obstetrics
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 Nocturia and Pelvic Organ Prolapse, run by Loyola University 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 5 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: withdrawn, as of the sponsor's last update on 2 Jun 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 was withdrawn before enrolling participants, so there are no results.
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?
Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia. (time frame: 1 year). 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 NCT02060331, which also lists 8 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 Jun 2016.