Last reviewed · How we verify
NCT05747027: PROD
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
NA trial testing Laparoscopic abdominal ventral rectopexy in Obstructed Defecation in 15 participants. Terminated before completion.
30 May 2025
Quick facts
| Lead sponsor | Endeavor Health |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 16 May 2024 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 May 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Laparoscopic abdominal ventral rectopexy
- Transvaginal sacrospinous rectopexy
Conditions studied
- Obstructed Defecation — all drugs for Obstructed Defecation →
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
Sponsor
Endeavor Health — full company profile →
Who can join
Adults 18 to 80, female only, with Obstructed Defecation or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population. Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms. During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05747027
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05747027 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Endeavor Health
- Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05747027.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing