Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
| Status: | Withdrawn |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2016 |
| Start Date: | January 2014 |
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.
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.
1. 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.
2. 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.
3. 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.
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.
2. 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.
3. 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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