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NCT Number: NCT03539107

Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)

Exclusion criteria

  • Patients who require prolonged Foley catheter or suprapubic catheter

Treatment and study plan

Retrograde bladder fill

Procedure

Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.

spontaneous void

Other

Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.

Primary outcomes

  1. Failure rate

    Time frame: Up to 2 days post op

    The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .

Secondary outcomes

  1. False pass rate

    Time frame: up to 30 days after discharge.

    The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty .

  2. Force of stream (FOS)

    Time frame: Up to 2 days post op.

    Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).

  3. Force of stream (FOS)

    Time frame: Up to 2 days post-surgery.

    Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).

  4. Patient Satisfaction Questionnaire for Voiding Assessment-method used

    Time frame: Up to 2 days post-surgery.

    This question asks "How satisfied were you with the method we used to evaluate how well you could urinate after our surgery?" It is measured on a continuum from 0 (very dissatisfied) to 100 (very satisfied).

  5. Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions

    Time frame: Up to 2 days post-surgery.

    This question asks "Did you experience any negative emotions such as fear or anxiety when we were evaluating urination after our surgery?" It is measured on a continuum from 0 (many negative emotions) to 100 (no negative emotions).

  6. Patient Satisfaction Questionnaire for Voiding Assessment-recommend method

    Time frame: Up to 2 days post-surgery.

    This question asks "How likely would you be to recommend to a friend or family member, the method we used to evaluate your urination after our surgery, if they were in the same situation?" It is measured on a continuum from 0 (very unlikely) to 100 (very likely).

  7. Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method

    Time frame: Up to 2 days post-surgery.

    This question asks "How convenient was the method we used to evaluate your urination after our surgery (e.g. time, ease etc.)? It is measured on a continuum from 0 (very inconvenient) to 100 (very convenient).

  8. Patient Satisfaction Questionnaire for Voiding Assessment-preferred method

    Time frame: Up to 2 days post-surgery.

    This question asks the patient: "If it was all up to you, which It is measured on a continuum from 0 (strongly prefer backfill before catheter) to 100 (strongly prefer no backfill before catheter removal).

  9. Postoperative pain score

    Time frame: One day post-surgery.

    This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced.

  10. Urinary tract infection (UTI)

    Time frame: Up to 30 days post surgery.

    UTI is defined as culture-proven bladder infection or, in the absence of a culture, clinical suspicion of a bladder infection that resulted in treatment.

  11. Post-operative complications

    Time frame: Up to 30 days post-surgery.

    Post-operative complications assessed by medical record review.

  12. Length of hospital stay

    Time frame: Up to 2 days post-surgery.

    Length of hospital stay assessed by medical record review.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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