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CompletedNCT05518175POPSUpdated Jan 26, 2026

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

An interventional study of Traditional laparoscopy and Single site laparoscopy in Sterility, Female, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Sterility, Female

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Keywords

  • laparoscopy
  • quality of recovery
  • vaginal natural orifice transluminal endoscopic surgery
03

In context

Infertility, Female

540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.

This study's enrollment of 255 is above the median of 100 across 371 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
255 participants (actual)

Study arms

  • Active comparator
    Route A: Traditional laparoscopy

    Procedure: Traditional laparoscopy

  • Experimental
    Route B: Single site laparoscopy

    Procedure: Single site laparoscopy

  • Experimental
    Route C:V-Notes surgery

    Procedure: V-Notes surgery

Interventions

  • ProcedureTraditional laparoscopy

    Utilizes three or four ports for access and retrieval.

  • ProcedureSingle site laparoscopy

    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.

  • ProcedureV-Notes surgery

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Cosmesis as assessed by the Body Image Questionnaire

    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

    Time frame: 2 weeks post surgery

  2. Cosmesis as assessed by the Body Image Questionnaire

    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

    Time frame: 6 weeks post surgery

  3. Cosmesis as assessed by the Body Image Questionnaire

    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

    Time frame: 3 months post surgery

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

    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.

    Time frame: Baseline, 3 months post surgery

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

    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)

    Time frame: 24 hours post surgery

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

    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)

    Time frame: 2 weeks post surgery

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

    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)

    Time frame: 6 weeks post surgery

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

    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)

    Time frame: 3 months post surgery

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

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

    Time frame: 3 months post surgery

  10. Patient satisfaction as assessed by the satisfaction scale

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

    Time frame: 3 months post surgery

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518175
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Randa Jalloul (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 26, 2022
Start date
Nov 15, 2022
Primary completion
Mar 7, 2025
Completion
Jun 5, 2025
Last update
Jan 26, 2026

Study contacts

Randa J Jalloul, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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