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Completed

NCT Number: NCT05518175

Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial)

The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.

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Key information

Conditions

Sterility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
  • non-prolapsed uterus
  • Patients should able to provide written consent

Exclusion criteria

  • Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
  • Postpartum (immediate) tubal sterilization
  • Tubal sterilization during a cesarean section

Treatment and study plan

Traditional laparoscopy

Procedure

Utilizes three or four ports for access and retrieval.

Single site laparoscopy

Procedure

One port is placed via a 2 to 3 cm umbilical/fascia incision. With this technique, there is a single incision, hidden in the umbilicus.

V-Notes surgery

Procedure

One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.

Primary outcomes

  1. Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire

    Time frame: 24 hours after surgery

    This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome

Secondary outcomes

  1. Cosmesis as assessed by the Body Image Questionnaire

    Time frame: 2 weeks post surgery

    This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image

  2. Cosmesis as assessed by the Body Image Questionnaire

    Time frame: 6 weeks post surgery

    This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image

  3. Cosmesis as assessed by the Body Image Questionnaire

    Time frame: 3 months post surgery

    This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image

  4. Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)

    Time frame: Baseline, 3 months post surgery

    This has 9 items that address sexual dysfunctions. Each of these items are scored on a six-point scale ranging from 0 to 5, higher the score the better sexual function.

  5. Pain as assessed by the Resting Visual Analog Scale (VAS)

    Time frame: 24 hours post surgery

    Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)

  6. Pain as assessed by the Resting Visual Analog Scale (VAS)

    Time frame: 2 weeks post surgery

    Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)

  7. Pain as assessed by the Resting Visual Analog Scale (VAS)

    Time frame: 6 weeks post surgery

    Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)

  8. Pain as assessed by the Resting Visual Analog Scale (VAS)

    Time frame: 3 months post surgery

    Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)

  9. Pain as assessed by the Dynamic Visual Analog Scale (VAS)

    Time frame: 3 months post surgery

    Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain after a voluntary cough (dynamic VAS)

  10. Patient satisfaction as assessed by the satisfaction scale

    Time frame: 3 months post surgery

    Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes

Acronym: POPS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2022
Registry last updated
Jan 26, 2026

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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