Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot 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.
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.
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